Upadacitinib History and Updates

250 events · 2014 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 12, 2026.

FDA Approvals

Label Revisions

350

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-12Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Upadacitinib since 2014, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (18)

2026

Primary completionUpadacitinib Phase 3 Trial for Atopic Dermatitis Sleep Disturbance Withdrawn· Jan 5, 2026

2025

FDA approval (supplemental)Rinvoq (Upadacitinib) Receives FDA Supplemental Approval for Efficacy· Oct 10, 2025
Primary completionUpadacitinib Phase 3 Vitiligo Trial Reaches Primary Completion· Sep 23, 2025
Results postedUpadacitinib Atopic Dermatitis Trial Shows EASI 90/75/100 Scores at Week 24· Jul 29, 2025
FDA approval (supplemental)Rinvoq (Upadacitinib) Receives FDA Supplemental Approval for Efficacy· Apr 28, 2025
Results postedUpadacitinib Shows Improved Remission, Reduced Corticosteroid Use in Giant…· Mar 7, 2025
Results postedUpadacitinib Shows Superior Efficacy vs. Dupilumab in Atopic Dermatitis Trial· Feb 14, 2025
Pivotal publicationUpadacitinib Phase 3 Trial Results Published for Giant-Cell Arteritis· Jan 1, 2025

2024

FDA approvalRinvoq (Upadacitinib) Receives FDA Approval for New Dosage Form· Apr 26, 2024

2022

Pivotal publicationUpadacitinib Phase 3 Trial Results Published for Non-Radiographic Axial…· Jan 1, 2022

2021

Primary completionUpadacitinib Shows Significant Improvement in Atopic Dermatitis Symptoms· Mar 11, 2021
Pivotal publicationUpadacitinib Psoriatic Arthritis Trial Results Published· Jan 1, 2021
Pivotal publicationUpadacitinib Shows Efficacy in Moderate-to-Severe Atopic Dermatitis Pivotal…· Jan 1, 2021
Pivotal publicationUpadacitinib Efficacy and Safety Results Published for Atopic Dermatitis· Jan 1, 2021

2020

Pivotal publicationUpadacitinib Phase 3 Study vs. Abatacept for Rheumatoid Arthritis Published· Jan 1, 2020

2019

Pivotal publicationUpadacitinib Monotherapy Shows Efficacy in Rheumatoid Arthritis· Jan 1, 2019

2018

Pivotal publicationUpadacitinib SELECT-BEYOND: Safety, Efficacy in Biologic-Refractory RA· Jan 1, 2018
Pivotal publicationUpadacitinib: Pivotal Safety and Efficacy Data for Rheumatoid Arthritis…· Jan 1, 2018

Upcoming & expected milestones

Primary completionJun 30, 2026· ClinicalTrials.gov

Primary completion: NCT06144567

Response to Upadacitinib of Enthesitis Evaluated by Ultrasound in Patients With Psoriatic Arthritis

Primary completionJun 30, 2026· ClinicalTrials.gov

Primary completion: NCT05094128

A Study to Assess Disease Activity in Adult Participants With Axial Spondyloarthritis Who Receive Upadacitinib in a Real-world Setting

Trial startedJul 1, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07502339

Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis

Trial startedJul 31, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07588568

A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis

Primary completionJul 31, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05814627

Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants

Primary completionAug 1, 2026· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT06873100

Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis

Trial startedAug 1, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07352566

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

FDA approval (supplemental)Aug 19, 2026· FDA

FDA approved supplemental application for Rinvoq (upadacitinib) — Manufacturing (CMC) (NDA 218347 S-3)

Sponsor: ABBVIE. Class: Manufacturing (CMC).

Primary completionAug 31, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT07425899

A Phase 1 Study of the Safety and How the Body Processes ABBV-722 and Upadacitinib After Multiple Oral Doses in Healthy Adult Participants

Primary completionAug 31, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06389136

A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab

Primary completionSep 30, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT07008846

Efficacy of Tofacitinib, Methotrexate Combination Therapy Versus Upadacitinib, Methotrexate Combination Therapy in Moderate to Severe Rheuma

Primary completionDec 30, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06862284

Therapeutic Effect of Upadacitinib in Primary Sjögren's Syndrome

Primary completionDec 31, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06928272

Long Covid (LC)-REVITALIZE - A Long Covid Repurposed Drug Study

Primary completionDec 31, 2026· ClinicalTrials.gov

Phase 4 primary completion: NCT06520397

Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease

Primary completionDec 31, 2026· ClinicalTrials.gov

Primary completion: NCT06573593

Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study

Primary completionDec 31, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT07149467

Ustekinumab and Upadacitinib for Induction and Maintenance Therapy in Patients With Refractory Crohn's Disease: A Multicenter, Randomized, P

Primary completionJan 31, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT06701331

Safety and Efficacy of Upadacitinib in Combination With Topical Corticosteroids in Children From 2 to Less Than 12 Years of Age in Japan Wit

Primary completionMar 30, 2027· ClinicalTrials.gov

Phase 4 primary completion: NCT07546097

Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis（UPFRONT）

Primary completionMar 31, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT05843643

Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic

Primary completionApr 30, 2027· ClinicalTrials.gov

Primary completion: NCT05094128

A Study to Assess Disease Activity in Adult Participants With Axial Spondyloarthritis Who Receive Upadacitinib in a Real-world Setting

Primary completionMay 31, 2027· ClinicalTrials.gov

Phase 1 primary completion: NCT03725007

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile

Primary completionMay 31, 2027· ClinicalTrials.gov

Phase 4 primary completion: NCT07018206

Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis

Primary completionMay 31, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT06660693

Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis

Primary completionJun 8, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT06227910

A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease

Primary completionJun 30, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT06332534

Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Dis

Primary completionJun 30, 2027· ClinicalTrials.gov

EARLY_Phase 1 primary completion: NCT06684522

Upadacitinib as a Novel Treatment for Refractory Eyelid Dermatitis

Primary completionJul 30, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT07064889

The Combination of Upadacitinib and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia

Primary completionJul 31, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT03006068

A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)

Primary completionSep 30, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT03345823

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Co

Primary completionSep 30, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT07138898

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Primary completionDec 15, 2027· ClinicalTrials.gov

Primary completion: NCT06016517

Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis

Primary completionDec 31, 2027· ClinicalTrials.gov

Primary completion: NCT07487311

A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat In

Primary completionFeb 1, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT07492251

Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Randomized Placebo-cont

Primary completionMar 31, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT05889182

A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to S

Primary completionMar 31, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT06118411

A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo

Primary completionApr 1, 2028· ClinicalTrials.gov

Phase 4 primary completion: NCT07550673

Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE）

Primary completionAug 1, 2028· ClinicalTrials.gov

Phase 4 primary completion: NCT07502339

Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis

Primary completionAug 31, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT05782907

Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With

Primary completionAug 31, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT04161898

A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK)

Primary completionSep 30, 2028· ClinicalTrials.gov

Phase 4 primary completion: NCT06454188

A Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients With Active Psoriatic Arthritis

Primary completionDec 31, 2028· ClinicalTrials.gov

Primary completion: NCT06780683

Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease

Primary completionDec 31, 2028· ClinicalTrials.gov

Phase 4 primary completion: NCT07510191

TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response

Primary completionDec 31, 2028· ClinicalTrials.gov

Primary completion: NCT03358693

Molecular Signatures in Inflammatory Skin Disease

Primary completionFeb 28, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT07023302

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants in Japan With Alopecia Areata

Primary completionApr 1, 2029· ClinicalTrials.gov

Phase 4 primary completion: NCT06687551

JAK Inhibitor Dose TAPering Strategy Study

Primary completionJun 30, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT05609630

Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Move

Primary completionDec 31, 2029· ClinicalTrials.gov

Phase 4 primary completion: NCT07258771

Upadacitinib Combined With Corticosteroids vs Corticosteroid Monotherapy Induction for Inpatients and Outpatients With Acute Severe Ulcerati

Primary completionFeb 28, 2030· ClinicalTrials.gov

Phase 2 primary completion: NCT07588568

A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis

Primary completionApr 30, 2030· ClinicalTrials.gov

Phase 3 primary completion: NCT06012240

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata

Primary completionJun 1, 2030· ClinicalTrials.gov

Phase 4 primary completion: NCT07352566

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Past events

2026

Primary completionJun 1, 2026· ClinicalTrials.gov

NA primary completion: NCT06454461

Efficacy of Upadacitinib After NECS in Vitiligo

Trial startedJun 1, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07492251

Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Randomized Placebo-cont

Trial startedMay 31, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07018206

Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis

Primary completionMay 31, 2026· ClinicalTrials.gov

Phase 4 primary completion: NCT05867329

Feasibility Pilot Sequential Multiple Assignment Randomized Trial (SMART) for Acute Severe Ulcerative Colitis

Trial startedMay 31, 2026· ClinicalTrials.gov

Trial started: NCT07448363

Atopic Dermatitis Treated With Dupilumab and JAK Inhibitors in Costa Rica

Trial registeredMay 19, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07597577

Upadacitinib in Isolated Small Bowel Versus Non-Small Bowel Crohn's Disease

Trial registeredMay 15, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07588568

A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis

Trial startedMay 1, 2026· ClinicalTrials.gov

Trial started: NCT06016517

Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis

Trial registeredApr 24, 2026· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07550673

Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE）

Trial registeredApr 22, 2026· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07546097

Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis（UPFRONT）

Trial startedApr 20, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07550673

Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE）

Trial registeredApr 3, 2026· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07510191

TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response

Primary completionMar 31, 2026· ClinicalTrials.gov

EARLY_Phase 1 primary completion: NCT06684522

Upadacitinib As a Novel Treatment for Refractory Eyelid Dermatitis

Trial registeredMar 31, 2026· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07502339

Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis

Trial registeredMar 25, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07492251

Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Randomized Placebo-cont

Trial startedMar 23, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07546097

Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis（UPFRONT）

Trial registeredMar 23, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07487311

A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat In

Trial registeredMar 16, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07472309

Effectiveness and Safety of Upadacitinib for Acute Severe Ulcerative Colitis

Trial registeredMar 4, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07448363

Atopic Dermatitis Treated With Dupilumab and JAK Inhibitors in Costa Rica

Primary completionMar 3, 2026· ClinicalTrials.gov

Primary completion: NCT07472309

Effectiveness and Safety of Upadacitinib for Acute Severe Ulcerative Colitis

Trial registeredMar 2, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07442045

Real-World Effectiveness and Safety of Upadacitinib Plus Vedolizumab vs Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulce

Trial startedMar 1, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07510191

TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response

Trial startedFeb 26, 2026· ClinicalTrials.gov

Phase 1 trial started: NCT07425899

A Phase 1 Study of the Safety and How the Body Processes ABBV-722 and Upadacitinib After Multiple Oral Doses in Healthy Adult Participants

Trial registeredFeb 23, 2026· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT07425899

A Phase 1 Study of the Safety and How the Body Processes ABBV-722 and Upadacitinib After Multiple Oral Doses in Healthy Adult Participants

Trial registeredJan 20, 2026· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07352566

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Trial startedJan 16, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07258771

Upadacitinib Combined With Corticosteroids vs Corticosteroid Monotherapy Induction for Inpatients and Outpatients With Acute Severe Ulcerati

Trial startedJan 7, 2026· ClinicalTrials.gov

Trial started: NCT07487311

A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat In

Primary completionJan 5, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06390722

A Study to Assess the Effect of Upadacitinib in Atopic Dermatitis-induced Sleep Disturbance in Adults With Moderate to Severe Atopic Dermati

Trial startedJan 1, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07352566

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

2025

Primary completionDec 31, 2025· ClinicalTrials.gov

Primary completion: NCT06630715

Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis.

Primary completionDec 31, 2025· ClinicalTrials.gov

Phase 4 primary completion: NCT06773403

Upadacitinib for Prurigo Nodularis

Primary completionDec 31, 2025· ClinicalTrials.gov

Primary completion: NCT06937788

Replication of the Heads Up Atopic Dermatitis Trial With Registry Data

Primary completionDec 30, 2025· ClinicalTrials.gov

Phase 1 primary completion: NCT06902987

Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease

Trial registeredDec 2, 2025· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07258771

Upadacitinib Combined With Corticosteroids vs Corticosteroid Monotherapy Induction for Inpatients and Outpatients With Acute Severe Ulcerati

Primary completionOct 31, 2025· ClinicalTrials.gov

NA primary completion: NCT06095596

Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis

FDA approval (supplemental)Oct 10, 2025· FDA

FDA approved supplemental application for Rinvoq (upadacitinib) — Efficacy (NDA 211675 S-28)

Sponsor: ABBVIE. Class: Efficacy.

FDA approval (supplemental)Oct 10, 2025· FDA

FDA approved supplemental application for Rinvoq (upadacitinib) — Labeling (NDA 218347 S-5)

Sponsor: ABBVIE. Class: Labeling.

Primary completionSep 30, 2025· ClinicalTrials.gov

Primary completion: NCT07442045

Real-World Effectiveness and Safety of Upadacitinib Plus Vedolizumab vs Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulce

Trial startedSep 30, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT07138898

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Primary completionSep 23, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT06118411

A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo

Trial startedSep 10, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT07149467

Ustekinumab and Upadacitinib for Induction and Maintenance Therapy in Patients With Refractory Crohn's Disease: A Multicenter, Randomized, P

Trial startedSep 10, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06928272

Long Covid (LC)-REVITALIZE - A Long Covid Repurposed Drug Study

Trial registeredSep 2, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07149467

Ustekinumab and Upadacitinib for Induction and Maintenance Therapy in Patients With Refractory Crohn's Disease: A Multicenter, Randomized, P

Trial registeredAug 24, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07138898

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

FDA approval (supplemental)Aug 12, 2025· FDA

FDA approved supplemental application for Rinvoq (upadacitinib) — Manufacturing (CMC) (NDA 211675 S-29)

Sponsor: ABBVIE. Class: Manufacturing (CMC).

Trial startedJul 30, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT07064889

The Combination of Upadacitinib and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia

Results postedJul 29, 2025· ClinicalTrials.gov

Trial results posted: NCT05507580

A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic D

Trial registeredJul 23, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07080346

Upadacitinib for Refractory Behcet's Syndrome

Trial registeredJul 15, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07064889

The Combination of Upadacitinib and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia

Trial startedJun 19, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT07023302

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants in Japan With Alopecia Areata

Trial registeredJun 16, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07023302

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants in Japan With Alopecia Areata

Trial registeredJun 12, 2025· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07018206

Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis

Trial registeredJun 6, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07008846

Efficacy of Tofacitinib, Methotrexate Combination Therapy Versus Upadacitinib, Methotrexate Combination Therapy in Moderate to Severe Rheuma

Primary completionJun 6, 2025· ClinicalTrials.gov

Phase 4 primary completion: NCT06773403

Upadacitinib for Prurigo Nodularis

Trial startedMay 10, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT07008846

Efficacy of Tofacitinib, Methotrexate Combination Therapy Versus Upadacitinib, Methotrexate Combination Therapy in Moderate to Severe Rheuma

FDA approval (supplemental)Apr 28, 2025· FDA

FDA approved supplemental application for Rinvoq (upadacitinib) — Efficacy (NDA 211675 S-25)

Sponsor: ABBVIE. Class: Efficacy.

Trial registeredApr 22, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06937788

Replication of the Heads Up Atopic Dermatitis Trial With Registry Data

Trial startedApr 16, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06660693

Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis

Trial registeredApr 15, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06928272

Long Covid (LC)-REVITALIZE - A Long Covid Repurposed Drug Study

Trial registeredApr 10, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06922331

Upadacitinib for Refractory IBD in Asian Children and Elderly: Age-Stratified Analysis

Trial registeredMar 30, 2025· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06902987

Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease

FDA approval (supplemental)Mar 26, 2025· FDA

FDA approved supplemental application for Rinvoq (upadacitinib) — Labeling (NDA 211675 S-27)

Sponsor: ABBVIE. Class: Labeling.

FDA approval (supplemental)Mar 26, 2025· FDA

FDA approved supplemental application for Rinvoq (upadacitinib) — Labeling (NDA 218347 S-2)

Sponsor: ABBVIE. Class: Labeling.

Trial registeredMar 12, 2025· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT06873100

Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis

Trial startedMar 10, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06862284

Therapeutic Effect of Upadacitinib in Primary Sjögren's Syndrome

Results postedMar 7, 2025· ClinicalTrials.gov

Trial results posted: NCT03725202

A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis

Trial registeredMar 6, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06862284

Therapeutic Effect of Upadacitinib in Primary Sjögren's Syndrome

Results postedFeb 14, 2025· ClinicalTrials.gov

Trial results posted: NCT05601882

A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Ad

Trial registeredJan 17, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06780683

Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease

Results postedJan 14, 2025· ClinicalTrials.gov

Trial results posted: NCT04451772

A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Partici

Trial registeredJan 14, 2025· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06773403

Upadacitinib for Prurigo Nodularis

Results postedJan 9, 2025· ClinicalTrials.gov

Trial results posted: NCT04195698

Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis

Trial registeredJan 6, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06758947

Use of Selective JAK Inhibitor in ILD and Skin Tightness of Systemic Sclerosis Versus MMF

Trial startedJan 2, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06227910

A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease

Trial startedJan 1, 2025· ClinicalTrials.gov

Phase 4 trial started: NCT06687551

JAK Inhibitor Dose TAPering Strategy Study

Pivotal publicationJan 1, 2025· PubMed

A Phase 3 Trial of Upadacitinib for Giant-Cell Arteritis. (N Engl J Med)

SELECT-GCA — A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis

2024

Primary completionDec 31, 2024· ClinicalTrials.gov

Primary completion: NCT06922331

Upadacitinib for Refractory IBD in Asian Children and Elderly: Age-Stratified Analysis

Trial startedDec 31, 2024· ClinicalTrials.gov

EARLY_Phase 1 trial started: NCT06684522

Upadacitinib As a Novel Treatment for Refractory Eyelid Dermatitis

Trial startedDec 22, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06701331

Safety and Efficacy of Upadacitinib in Combination With Topical Corticosteroids in Children From 2 to Less Than 12 Years of Age in Japan Wit

Primary completionDec 20, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT07080346

Upadacitinib for Refractory Behcet's Syndrome

Trial startedDec 4, 2024· ClinicalTrials.gov

NA trial started: NCT06454461

Efficacy of Upadacitinib After NECS in Vitiligo

Trial startedDec 3, 2024· ClinicalTrials.gov

Phase 4 trial started: NCT06454188

A Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients With Active Psoriatic Arthritis

Trial registeredNov 22, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06701331

Safety and Efficacy of Upadacitinib in Combination With Topical Corticosteroids in Children From 2 to Less Than 12 Years of Age in Japan Wit

Trial startedNov 15, 2024· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT06873100

Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis

Trial registeredNov 13, 2024· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06687551

JAK Inhibitor Dose TAPering Strategy Study

Trial registeredNov 12, 2024· ClinicalTrials.gov

EARLY_Phase 1 trial registered on ClinicalTrials.gov: NCT06684522

Upadacitinib As a Novel Treatment for Refractory Eyelid Dermatitis

Primary completionOct 31, 2024· ClinicalTrials.gov

Primary completion: NCT06498167

Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)

Trial registeredOct 28, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06660693

Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis

Primary completionOct 12, 2024· ClinicalTrials.gov

Primary completion: NCT07597577

Upadacitinib in Isolated Small Bowel Versus Non-Small Bowel Crohn's Disease

Trial registeredOct 8, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06630715

Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis.

Results postedOct 8, 2024· ClinicalTrials.gov

Trial results posted: NCT04927975

Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental V

Primary completionSep 30, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT06379958

Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects

Primary completionAug 29, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT03646604

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Participants With Severe Atopic Dermatitis

Trial registeredAug 27, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06573593

Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study

Trial startedAug 19, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06461897

A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to

Trial startedAug 8, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06332534

Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Dis

Trial startedJul 29, 2024· ClinicalTrials.gov

Trial started: NCT06573593

Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study

Trial registeredJul 25, 2024· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06520397

Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease

Trial startedJul 23, 2024· ClinicalTrials.gov

Trial started: NCT06630715

Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis.

Trial startedJul 15, 2024· ClinicalTrials.gov

Phase 4 trial started: NCT06520397

Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease

Trial registeredJul 12, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06498167

Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)

Primary completionJul 11, 2024· ClinicalTrials.gov

Phase 4 primary completion: NCT05507580

A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic D

Trial startedJul 1, 2024· ClinicalTrials.gov

Trial started: NCT06498167

Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)

Trial registeredJun 17, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06461897

A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to

Primary completionJun 15, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT06758947

Use of Selective JAK Inhibitor in ILD and Skin Tightness of Systemic Sclerosis Versus MMF

Trial startedJun 14, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06389136

A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab

Trial registeredJun 12, 2024· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT06454461

Efficacy of Upadacitinib After NECS in Vitiligo

Trial registeredJun 12, 2024· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06454188

A Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients With Active Psoriatic Arthritis

Trial startedMay 23, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06390722

A Study to Assess the Effect of Upadacitinib in Atopic Dermatitis-induced Sleep Disturbance in Adults With Moderate to Severe Atopic Dermati

Primary completionApr 30, 2024· ClinicalTrials.gov

Primary completion: NCT04530305

Microbiota Analysis to Predict Outcomes of Rheumatoid Arthritis Patients Treated With JAK-inhibitor

Trial registeredApr 30, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06390722

A Study to Assess the Effect of Upadacitinib in Atopic Dermatitis-induced Sleep Disturbance in Adults With Moderate to Severe Atopic Dermati

Trial registeredApr 29, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06389136

A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab

FDA approval (supplemental)Apr 26, 2024· FDA

FDA approved supplemental application for Rinvoq (upadacitinib) — Efficacy (NDA 211675 S-21)

Sponsor: ABBVIE. Class: Efficacy.

FDA approvalApr 26, 2024· FDA

FDA approved Rinvoq (upadacitinib) (NDA 218347)

Sponsor: ABBVIE. Class: Type 3 - New Dosage Form.

FDA approval (supplemental)Apr 26, 2024· FDA

FDA approved supplemental application for Rinvoq (upadacitinib) — Efficacy (NDA 211675 S-22)

Sponsor: ABBVIE. Class: Efficacy.

Trial registeredApr 23, 2024· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06379958

Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects

Trial startedApr 9, 2024· ClinicalTrials.gov

Phase 4 trial started: NCT06773403

Upadacitinib for Prurigo Nodularis

Trial startedApr 8, 2024· ClinicalTrials.gov

Phase 1 trial started: NCT06379958

Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects

Primary completionApr 4, 2024· ClinicalTrials.gov

Phase 4 primary completion: NCT05080218

COVID-19 VaccinE Response in Rheumatology Patients

Trial registeredMar 27, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06332534

Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Dis

Primary completionMar 19, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT05601882

A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Ad

Trial registeredFeb 23, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06274996

Efficacy and Safety Analysis of Upadacitinib in Inflammatory Bowel Disease

Primary completionFeb 6, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT03725202

A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis

Trial registeredJan 29, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06227910

A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease

Trial startedJan 25, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT07080346

Upadacitinib for Refractory Behcet's Syndrome

Trial startedJan 17, 2024· ClinicalTrials.gov

Phase 1 trial started: NCT06902987

Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease

Primary completionJan 3, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT04451772

A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Partici

Trial startedJan 1, 2024· ClinicalTrials.gov

Trial started: NCT06780683

Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease

2023

Trial startedDec 31, 2023· ClinicalTrials.gov

Trial started: NCT06144567

Response to Upadacitinib of Enthesitis Evaluated by Ultrasound in Patients With Psoriatic Arthritis

Primary completionDec 31, 2023· ClinicalTrials.gov

Primary completion: NCT06274996

Efficacy and Safety Analysis of Upadacitinib in Inflammatory Bowel Disease

Trial startedDec 19, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT06118411

A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo

Primary completionNov 30, 2023· ClinicalTrials.gov

Phase 3 primary completion: NCT05121298

Discontinuation of Methotrexate in Rheumatoid Arthritis Patients Achieving Clinical Remission by Treatment With Upadacitinib Plus Methotrexa

Trial registeredNov 22, 2023· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06144567

Response to Upadacitinib of Enthesitis Evaluated by Ultrasound in Patients With Psoriatic Arthritis

FDA approval (supplemental)Nov 14, 2023· FDA

FDA approved supplemental application for Rinvoq (upadacitinib) — Labeling (NDA 211675 S-19)

Sponsor: ABBVIE. Class: Labeling.

Trial registeredNov 7, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06118411

A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo

Trial startedNov 6, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05782907

Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With

Trial startedNov 1, 2023· ClinicalTrials.gov

NA trial started: NCT06095596

Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis

Trial registeredOct 23, 2023· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT06095596

Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis

Trial startedOct 11, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT06012240

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata

Trial startedOct 2, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05609630

Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Move

Trial startedSep 30, 2023· ClinicalTrials.gov

Phase 4 trial started: NCT05867329

Feasibility Pilot Sequential Multiple Assignment Randomized Trial (SMART) for Acute Severe Ulcerative Colitis

Primary completionSep 11, 2023· ClinicalTrials.gov

Phase 3 primary completion: NCT04195698

Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis

Trial registeredAug 29, 2023· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06016517

Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis

Trial registeredAug 25, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06012240

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata

Trial startedJul 25, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05843643

Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic

Results postedJul 21, 2023· ClinicalTrials.gov

Trial results posted: NCT03978520

A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderatel

Primary completionJun 30, 2023· ClinicalTrials.gov

Phase 4 primary completion: NCT05153200

Early Changes in Pain, Disease Activity, and Ultrasound Evidence of Inflammatory Synovitis in Patients Receiving JAK-inhibitor vs. TNF-inhib

FDA approval (supplemental)Jun 22, 2023· FDA

FDA approved supplemental application for Rinvoq (upadacitinib) — Efficacy (NDA 211675 S-17)

Sponsor: ABBVIE. Class: Efficacy.

Trial startedJun 21, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05889182

A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to S

Trial startedJun 15, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05814627

Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants

Trial startedJun 6, 2023· ClinicalTrials.gov

Trial started: NCT07472309

Effectiveness and Safety of Upadacitinib for Acute Severe Ulcerative Colitis

Trial registeredJun 5, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05889182

A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to S

Trial startedMay 29, 2023· ClinicalTrials.gov

Phase 4 trial started: NCT05507580

A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic D

Trial registeredMay 22, 2023· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05867329

Feasibility Pilot Sequential Multiple Assignment Randomized Trial (SMART) for Acute Severe Ulcerative Colitis

FDA approval (supplemental)May 18, 2023· FDA

FDA approved supplemental application for Rinvoq (upadacitinib) — Efficacy (NDA 211675 S-15)

Sponsor: ABBVIE. Class: Efficacy.

Trial registeredMay 6, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05843643

Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic

Trial registeredApr 18, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05814627

Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants

FDA approval (supplemental)Apr 10, 2023· FDA

FDA approved supplemental application for Rinvoq (upadacitinib) — Labeling (NDA 211675 S-12)

Sponsor: ABBVIE. Class: Labeling.

Trial registeredMar 24, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05782907

Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With

Results postedFeb 6, 2023· ClinicalTrials.gov

Trial results posted: NCT04430855

A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Cha

Trial startedJan 15, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT06758947

Use of Selective JAK Inhibitor in ILD and Skin Tightness of Systemic Sclerosis Versus MMF

Primary completionJan 13, 2023· ClinicalTrials.gov

Phase 2 primary completion: NCT04927975

Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental V

Trial startedJan 1, 2023· ClinicalTrials.gov

Trial started: NCT07442045

Real-World Effectiveness and Safety of Upadacitinib Plus Vedolizumab vs Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulce

Trial startedJan 1, 2023· ClinicalTrials.gov

Trial started: NCT06922331

Upadacitinib for Refractory IBD in Asian Children and Elderly: Age-Stratified Analysis

2022

Trial startedNov 28, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05601882

A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Ad

Results postedNov 23, 2022· ClinicalTrials.gov

Trial results posted: NCT03345849

A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately

Trial registeredNov 8, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05609630

Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Move

Trial registeredNov 1, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05601882

A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Ad

FDA approval (supplemental)Oct 21, 2022· FDA

FDA approved supplemental application for Rinvoq (upadacitinib) — Efficacy (NDA 211675 S-10)

Sponsor: ABBVIE. Class: Efficacy.

Results postedSep 21, 2022· ClinicalTrials.gov

Trial results posted: NCT04169373

A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis

Trial registeredAug 19, 2022· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05507580

A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic D

Primary completionAug 19, 2022· ClinicalTrials.gov

Phase 3 primary completion: NCT03661138

A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to

Results postedAug 15, 2022· ClinicalTrials.gov

Trial results posted: NCT03345836

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Ina

Results postedJul 12, 2022· ClinicalTrials.gov

Trial results posted: NCT02049138

An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Adults With Rheumatoid Arthritis

Results postedJun 30, 2022· ClinicalTrials.gov

Trial results posted: NCT02819635

A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately

FDA approval (supplemental)Apr 29, 2022· FDA

FDA approved supplemental application for Rinvoq (upadacitinib) — Efficacy (NDA 211675 S-3)

Sponsor: ABBVIE. Class: Efficacy.

Results postedMar 31, 2022· ClinicalTrials.gov

Trial results posted: NCT03568318

A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe At

Results postedMar 28, 2022· ClinicalTrials.gov

Trial results posted: NCT03607422

A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)

FDA approval (supplemental)Mar 16, 2022· FDA

FDA approved supplemental application for Rinvoq (upadacitinib) — Efficacy (NDA 211675 S-7)

Sponsor: ABBVIE. Class: Efficacy.

Results postedFeb 3, 2022· ClinicalTrials.gov

Trial results posted: NCT03569293

Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)

Results postedFeb 2, 2022· ClinicalTrials.gov

Trial results posted: NCT03738397

A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis

Trial startedJan 31, 2022· ClinicalTrials.gov

Phase 4 trial started: NCT05153200

Early Changes in Pain, Disease Activity, and Ultrasound Evidence of Inflammatory Synovitis in Patients Receiving JAK-inhibitor vs. TNF-inhib

Results postedJan 25, 2022· ClinicalTrials.gov

Trial results posted: NCT03104400

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Respon

Results postedJan 25, 2022· ClinicalTrials.gov

Trial results posted: NCT03104374

A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Respons

Primary completionJan 19, 2022· ClinicalTrials.gov

Phase 2 primary completion: NCT03978520

A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderatel

FDA approval (supplemental)Jan 14, 2022· FDA

FDA approved supplemental application for Rinvoq (upadacitinib) — Efficacy (NDA 211675 S-4)

Sponsor: ABBVIE. Class: Efficacy.

Pivotal publicationJan 1, 2022· PubMed

Upadacitinib for the treatment of active non-radiographic axial spondyloarthritis (SELECT-AXIS 2): a randomised, double-blind, placebo-controlled, phase 3 trial (Lancet)

SELECT-AXIS 2 — A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis

2021

FDA approval (supplemental)Dec 14, 2021· FDA

FDA approved supplemental application for Rinvoq (upadacitinib) — Efficacy (NDA 211675 S-2)

Sponsor: ABBVIE. Class: Efficacy.

FDA approval (supplemental)Dec 14, 2021· FDA

FDA approved supplemental application for Rinvoq (upadacitinib) — Labeling (NDA 211675 S-5)

Sponsor: ABBVIE. Class: Labeling.

Primary completionDec 13, 2021· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT02819635

A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately

Trial registeredDec 10, 2021· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05153200

Early Changes in Pain, Disease Activity, and Ultrasound Evidence of Inflammatory Synovitis in Patients Receiving JAK-inhibitor vs. TNF-inhib

FDA approval (supplemental)Dec 2, 2021· FDA

FDA approved supplemental application for Rinvoq (upadacitinib) — Labeling (NDA 211675 S-8)

Sponsor: ABBVIE. Class: Labeling.

Results postedNov 26, 2021· ClinicalTrials.gov

Trial results posted: NCT03653026

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis

Trial startedNov 22, 2021· ClinicalTrials.gov

Trial started: NCT05094128

A Study to Assess Disease Activity in Adult Participants With Axial Spondyloarthritis Who Receive Upadacitinib in a Real-world Setting

Trial registeredNov 16, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05121298

Discontinuation of Methotrexate in Rheumatoid Arthritis Patients Achieving Clinical Remission by Treatment With Upadacitinib Plus Methotrexa

Trial startedNov 15, 2021· ClinicalTrials.gov

Phase 4 trial started: NCT05080218

COVID-19 VaccinE Response in Rheumatology Patients

Trial registeredOct 26, 2021· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT05094128

A Study to Assess Disease Activity in Adult Participants With Axial Spondyloarthritis Who Receive Upadacitinib in a Real-world Setting

Primary completionOct 15, 2021· ClinicalTrials.gov

Phase 3 primary completion: NCT03345849

A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately

Trial registeredOct 15, 2021· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05080218

COVID-19 VaccinE Response in Rheumatology Patients

Results postedSep 16, 2021· ClinicalTrials.gov

Trial results posted: NCT03823378

A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.