Ixekizumab History and Updates

209 events · 2010 – present

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

FDA Approvals

Label Revisions

215

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-04Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Ixekizumab since 2010, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (8)

2026

Primary completionIxekizumab Phase 3 Trial for Psoriasis and Obesity Completes Primary Phase· Jan 8, 2026

2025

Primary completionIxekizumab + Tirzepatide Phase 3 Trial for Psoriatic Arthritis & Obesity…· Nov 18, 2025
Results postedIxekizumab Hits 86% PASI-75 in Plaque Psoriasis, 84% ACR20 in Psoriatic…· Aug 22, 2025
Results postedIxekizumab Phase 2 Trial for Major Depressive Disorder Reports Mean MADRS Change· May 20, 2025

2020

Pivotal publicationIxekizumab Pivotal Trial for Non-Radiographic Axial Spondyloarthritis Published· Jan 1, 2020

2017

Pivotal publicationIxekizumab for active psoriatic arthritis after TNF inhibitor failure: 24-week…· Jan 1, 2017

2016

Pivotal publicationIxekizumab Phase 3 UNCOVER-3 Trial Results Published for Plaque Psoriasis· Jan 1, 2016

2015

Pivotal publicationIxekizumab Phase 3 Trial Results Published for Moderate-to-Severe Psoriasis· Jan 1, 2015

Upcoming & expected milestones

Trial startedAug 1, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07352566

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Primary completionFeb 28, 2027· ClinicalTrials.gov

Primary completion: NCT06786936

Evaluating the Role of IL-17 as an Orchestrator of Peripheral-central Cross Talk in Depressive Symptoms

Primary completionFeb 28, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT04589325

Ixekizumab Diabetes Intervention Trial (I-DIT)

Primary completionSep 30, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT07138898

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Primary completionDec 31, 2027· ClinicalTrials.gov

NA primary completion: NCT05503875

Immunoclassification of Psoriasis: a Strategy for Precision Medicine

Primary completionDec 31, 2027· ClinicalTrials.gov

Phase 4 primary completion: NCT04537689

Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis

Primary completionFeb 29, 2028· ClinicalTrials.gov

NA primary completion: NCT07443956

Combination of Biologic and Anti-obesity Therapies in Psoriatic Arthritis

Primary completionMar 1, 2028· ClinicalTrials.gov

Phase 4 primary completion: NCT06398106

Proactive TDM Versus Standard Use of Biologics in Psoriasis

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 7, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06945107

A Study of Switching to Picankibart in Chinese Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antib

Primary completionMay 31, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT05309616

Effects of Interleukin (IL)-17A Inhibition on Idiopathic Subglottic Stenosis

Primary completionMay 19, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT05309616

Effects of Interleukin (IL)-17A Inhibition on Idiopathic Subglottic Stenosis

Primary completionMar 31, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT07200986

Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects

Trial startedMar 9, 2026· ClinicalTrials.gov

NA trial started: NCT07443956

Combination of Biologic and Anti-obesity Therapies in Psoriatic Arthritis

Trial registeredMar 2, 2026· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT07443956

Combination of Biologic and Anti-obesity Therapies in Psoriatic Arthritis

Trial registeredJan 20, 2026· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07352566

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Primary completionJan 8, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06588283

Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight

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

NA primary completion: NCT06811558

Ixekizumab Versus Secukizumab in Over 70-year-old Patients with Psoriasis

Primary completionNov 18, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT06588296

Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight

Trial registeredOct 1, 2025· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT07200986

Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects

Trial startedSep 30, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT07138898

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Trial startedSep 17, 2025· ClinicalTrials.gov

Phase 1 trial started: NCT07200986

Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects

Trial registeredAug 24, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07138898

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Results postedAug 22, 2025· ClinicalTrials.gov

Trial results posted: NCT05855967

A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India

Primary completionJun 30, 2025· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT06374979

Efficacy and Safety of Ixekizumab in Patients with Refractory Guttate Psoriasis

Results postedJun 5, 2025· ClinicalTrials.gov

Trial results posted: NCT04527380

A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juven

Trial startedJun 2, 2025· ClinicalTrials.gov

Trial started: NCT06786936

Evaluating the Role of IL-17 as an Orchestrator of Peripheral-central Cross Talk in Depressive Symptoms

Trial startedMay 31, 2025· ClinicalTrials.gov

Phase 2/Phase 3 trial started: NCT06374979

Efficacy and Safety of Ixekizumab in Patients with Refractory Guttate Psoriasis

Trial startedMay 27, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06945107

A Study of Switching to Picankibart in Chinese Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antib

Results postedMay 20, 2025· ClinicalTrials.gov

Trial results posted: NCT04979910

Targeting IL-17A for Treatment-Resistant Depression

Trial registeredApr 25, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06945107

A Study of Switching to Picankibart in Chinese Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antib

Trial startedFeb 20, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT05309616

Effects of Interleukin (IL)-17A Inhibition on Idiopathic Subglottic Stenosis

Trial registeredFeb 6, 2025· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT06811558

Ixekizumab Versus Secukizumab in Over 70-year-old Patients with Psoriasis

Trial startedFeb 1, 2025· ClinicalTrials.gov

NA trial started: NCT06811558

Ixekizumab Versus Secukizumab in Over 70-year-old Patients with Psoriasis

Primary completionJan 30, 2025· ClinicalTrials.gov

Phase 4 primary completion: NCT04340076

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

Trial registeredJan 22, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06786936

Evaluating the Role of IL-17 as an Orchestrator of Peripheral-central Cross Talk in Depressive Symptoms

2024

Primary completionDec 30, 2024· ClinicalTrials.gov

Phase 4 primary completion: NCT06085079

Ixekizumab for the Management of Refractory Non-Infectious Uveitis: A Proof-of-Concept Study

Trial startedDec 20, 2024· ClinicalTrials.gov

Phase 4 trial started: NCT06398106

Proactive TDM Versus Standard Use of Biologics in Psoriasis

Primary completionOct 19, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT04610476

Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

Primary completionSep 30, 2024· ClinicalTrials.gov

NA primary completion: NCT05042635

Sequential Treatment of Psoriasis With Traditional Chinese and Western Medicine

Trial startedSep 30, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06588283

Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight

Trial startedSep 24, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06588296

Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight

Trial registeredSep 19, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06588283

Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight

Trial registeredSep 19, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06588296

Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight

FDA approval (supplemental)Aug 20, 2024· FDA

FDA approved supplemental application for Taltz (ixekizumab) — Labeling (BLA 125521 S-32)

Sponsor: ELI LILLY AND CO. Class: Labeling.

Primary completionAug 8, 2024· ClinicalTrials.gov

Phase 4 primary completion: NCT05855967

A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India

Trial registeredMay 3, 2024· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06398106

Proactive TDM Versus Standard Use of Biologics in Psoriasis

Trial registeredApr 19, 2024· ClinicalTrials.gov

Phase 2/Phase 3 trial registered on ClinicalTrials.gov: NCT06374979

Efficacy and Safety of Ixekizumab in Patients with Refractory Guttate Psoriasis

Primary completionApr 12, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT04979910

Targeting IL-17A for Treatment-Resistant Depression

Primary completionApr 4, 2024· ClinicalTrials.gov

Phase 4 primary completion: NCT05080218

COVID-19 VaccinE Response in Rheumatology Patients

Primary completionMar 25, 2024· ClinicalTrials.gov

EARLY_Phase 1 primary completion: NCT05030415

Ixekizumab in Adult Patients With Lichen Planus and Lichen Planopilaris

Primary completionFeb 19, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT04527380

A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juven

2023

Trial registeredOct 16, 2023· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06085079

Ixekizumab for the Management of Refractory Non-Infectious Uveitis: A Proof-of-Concept Study

FDA approval (supplemental)Sep 13, 2023· FDA

FDA approved supplemental application for Taltz (ixekizumab) — Labeling (BLA 125521 S-28)

Sponsor: ELI LILLY AND CO. Class: Labeling.

Trial startedJun 27, 2023· ClinicalTrials.gov

Phase 4 trial started: NCT05855967

A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India

Trial registeredMay 12, 2023· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05855967

A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India

Trial startedJan 1, 2023· ClinicalTrials.gov

NA trial started: NCT05503875

Immunoclassification of Psoriasis: a Strategy for Precision Medicine

2022

Trial startedNov 9, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT04589325

Ixekizumab Diabetes Intervention Trial (I-DIT)

Trial registeredAug 17, 2022· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT05503875

Immunoclassification of Psoriasis: a Strategy for Precision Medicine

FDA approval (supplemental)Jul 27, 2022· FDA

FDA approved supplemental application for Taltz (ixekizumab) — Labeling (BLA 125521 S-24)

Sponsor: ELI LILLY AND CO. Class: Labeling.

Results postedJun 28, 2022· ClinicalTrials.gov

Trial results posted: NCT04285229

A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis

Results postedJun 6, 2022· ClinicalTrials.gov

Trial results posted: NCT03137160

An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum

Trial startedJun 1, 2022· ClinicalTrials.gov

Phase 4 trial started: NCT06085079

Ixekizumab for the Management of Refractory Non-Infectious Uveitis: A Proof-of-Concept Study

FDA approval (supplemental)May 4, 2022· FDA

FDA approved supplemental application for Taltz (ixekizumab) — Efficacy (BLA 125521 S-23)

Sponsor: ELI LILLY AND CO. Class: Efficacy.

Results postedApr 8, 2022· ClinicalTrials.gov

Trial results posted: NCT04259346

A Study of Two Formulations of Ixekizumab in Healthy Participants

Trial registeredApr 4, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05309616

Effects of Interleukin (IL)-17A Inhibition on Idiopathic Subglottic Stenosis

2021

Trial startedNov 15, 2021· ClinicalTrials.gov

Phase 4 trial started: NCT05080218

COVID-19 VaccinE Response in Rheumatology Patients

Trial registeredOct 15, 2021· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05080218

COVID-19 VaccinE Response in Rheumatology Patients

Trial startedOct 1, 2021· ClinicalTrials.gov

NA trial started: NCT05042635

Sequential Treatment of Psoriasis With Traditional Chinese and Western Medicine

Trial registeredSep 13, 2021· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT05042635

Sequential Treatment of Psoriasis With Traditional Chinese and Western Medicine

Trial registeredSep 1, 2021· ClinicalTrials.gov

EARLY_Phase 1 trial registered on ClinicalTrials.gov: NCT05030415

Ixekizumab in Adult Patients With Lichen Planus and Lichen Planopilaris

Trial startedAug 27, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04979910

Targeting IL-17A for Treatment-Resistant Depression

Results postedAug 13, 2021· ClinicalTrials.gov

Trial results posted: NCT03942042

A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis

Trial startedAug 12, 2021· ClinicalTrials.gov

EARLY_Phase 1 trial started: NCT05030415

Ixekizumab in Adult Patients With Lichen Planus and Lichen Planopilaris

Trial registeredJul 28, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04979910

Targeting IL-17A for Treatment-Resistant Depression

Results postedJun 25, 2021· ClinicalTrials.gov

Trial results posted: NCT03364309

A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis

Results postedJun 18, 2021· ClinicalTrials.gov

Trial results posted: NCT03129100

A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis

Trial startedApr 13, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT04527380

A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juven

Primary completionMar 31, 2021· ClinicalTrials.gov

Phase 3 primary completion: NCT04285229

A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis

Primary completionMar 31, 2021· ClinicalTrials.gov

Phase 3 primary completion: NCT04724629

Survival TRial Using CytoKines in COVID-19 (STRUCK Trial)

FDA approval (supplemental)Mar 10, 2021· FDA

FDA approved supplemental application for Taltz (ixekizumab) — Labeling (BLA 125521 S-14)

Sponsor: ELI LILLY AND CO. Class: Labeling.

Primary completionFeb 19, 2021· ClinicalTrials.gov

Phase 1 primary completion: NCT04259346

A Study of Two Formulations of Ixekizumab in Healthy Participants

Trial registeredJan 26, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04724629

Survival TRial Using CytoKines in COVID-19 (STRUCK Trial)

Trial startedJan 5, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT04724629

Survival TRial Using CytoKines in COVID-19 (STRUCK Trial)

2020

Trial startedDec 10, 2020· ClinicalTrials.gov

Phase 4 trial started: NCT04537689

Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis

Trial registeredOct 30, 2020· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04610476

Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

Trial startedOct 19, 2020· ClinicalTrials.gov

Phase 3 trial started: NCT04610476

Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

Trial registeredOct 19, 2020· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04589325

Ixekizumab Diabetes Intervention Trial (I-DIT)

Trial registeredSep 3, 2020· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT04537689

Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis

Trial registeredAug 26, 2020· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04527380

A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juven

Trial startedAug 20, 2020· ClinicalTrials.gov

Phase 4 trial started: NCT04340076

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

Results postedJul 30, 2020· ClinicalTrials.gov

Trial results posted: NCT03848403

Study of Ixekizumab in Healthy Participants

Results postedJul 28, 2020· ClinicalTrials.gov

Trial results posted: NCT03573323

A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis

Primary completionJul 22, 2020· ClinicalTrials.gov

Phase 4 primary completion: NCT03942042

A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis

Results postedJul 22, 2020· ClinicalTrials.gov

Trial results posted: NCT03073213

A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

Results postedJul 1, 2020· ClinicalTrials.gov

Trial results posted: NCT03485976

Ixekizumab in the Treatment of Pityriasis Rubra Pilaris (PRP)

Results postedJun 24, 2020· ClinicalTrials.gov

Trial results posted: NCT03848416

A Study of Ixekizumab in Healthy Participants

Primary completionJun 4, 2020· ClinicalTrials.gov

Phase 3 primary completion: NCT03364309

A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis

FDA approval (supplemental)May 29, 2020· FDA

FDA approved supplemental application for Taltz (ixekizumab) — Efficacy (BLA 125521 S-19)

Sponsor: ELI LILLY AND CO. Class: Efficacy.

Primary completionMay 26, 2020· ClinicalTrials.gov

Phase 3 primary completion: NCT03129100

A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis

Results postedMay 21, 2020· ClinicalTrials.gov

Trial results posted: NCT03099538

Ixekizumab in the Treatment of Bullous Pemphigoid

Trial startedApr 10, 2020· ClinicalTrials.gov

Phase 3 trial started: NCT04285229

A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis

Trial registeredApr 9, 2020· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT04340076

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

FDA approval (supplemental)Mar 26, 2020· FDA

FDA approved supplemental application for Taltz (ixekizumab) — Efficacy (BLA 125521 S-20)

Sponsor: ELI LILLY AND CO. Class: Efficacy.

Results postedMar 17, 2020· ClinicalTrials.gov

Trial results posted: NCT03073200

Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

Results postedMar 13, 2020· ClinicalTrials.gov

Trial results posted: NCT02757352

A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis

Trial registeredFeb 26, 2020· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04285229

A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis

Trial registeredFeb 6, 2020· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04259346

A Study of Two Formulations of Ixekizumab in Healthy Participants

Trial startedFeb 5, 2020· ClinicalTrials.gov

Phase 1 trial started: NCT04259346

A Study of Two Formulations of Ixekizumab in Healthy Participants

Pivotal publicationJan 1, 2020· PubMed

Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial. (Lancet)

COAST-X — A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis

2019

Results postedNov 19, 2019· ClinicalTrials.gov

Trial results posted: NCT02696785

A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis

Results postedNov 15, 2019· ClinicalTrials.gov

Trial results posted: NCT02584855

A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

Results postedOct 30, 2019· ClinicalTrials.gov

Trial results posted: NCT02696798

A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis

Primary completionOct 14, 2019· ClinicalTrials.gov

Phase 2 primary completion: NCT03485976

Ixekizumab in the Treatment of Pityriasis Rubra Pilaris (PRP)

FDA approval (supplemental)Aug 23, 2019· FDA

FDA approved supplemental application for Taltz (ixekizumab) — Efficacy (BLA 125521 S-16)

Sponsor: ELI LILLY AND CO. Class: Efficacy.

Primary completionJul 18, 2019· ClinicalTrials.gov

Phase 1 primary completion: NCT03848403

Study of Ixekizumab in Healthy Participants

Primary completionJul 15, 2019· ClinicalTrials.gov

Phase 4 primary completion: NCT03573323

A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis

Trial startedJul 5, 2019· ClinicalTrials.gov

Phase 4 trial started: NCT03942042

A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis

Primary completionJun 7, 2019· ClinicalTrials.gov

Phase 1 primary completion: NCT03848416

A Study of Ixekizumab in Healthy Participants

Primary completionJun 6, 2019· ClinicalTrials.gov

Phase 2 primary completion: NCT03099538

Ixekizumab in the Treatment of Bullous Pemphigoid

Primary completionMay 14, 2019· ClinicalTrials.gov

Phase 1 primary completion: NCT03073213

A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

Trial registeredMay 8, 2019· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT03942042

A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis

Results postedApr 2, 2019· ClinicalTrials.gov

Trial results posted: NCT03151551

A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis

Results postedMar 12, 2019· ClinicalTrials.gov

Trial results posted: NCT02993471

A Study of Ixekizumab in Participants With Plaque Psoriasis

Primary completionMar 1, 2019· ClinicalTrials.gov

Phase 3 primary completion: NCT02757352

A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis

Trial registeredFeb 20, 2019· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT03848403

Study of Ixekizumab in Healthy Participants

Trial registeredFeb 20, 2019· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT03848416

A Study of Ixekizumab in Healthy Participants

Primary completionFeb 7, 2019· ClinicalTrials.gov

Phase 3 primary completion: NCT03073200

Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

Trial startedJan 29, 2019· ClinicalTrials.gov

Phase 1 trial started: NCT03848403

Study of Ixekizumab in Healthy Participants

Trial startedJan 29, 2019· ClinicalTrials.gov

Phase 1 trial started: NCT03848416

A Study of Ixekizumab in Healthy Participants

2018

Primary completionNov 15, 2018· ClinicalTrials.gov

Phase 4 primary completion: NCT03151551

A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis

Trial startedNov 9, 2018· ClinicalTrials.gov

Phase 4 trial started: NCT03573323

A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis

Primary completionOct 30, 2018· ClinicalTrials.gov

Phase 3 primary completion: NCT02584855

A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

Primary completionAug 16, 2018· ClinicalTrials.gov

Phase 2 primary completion: NCT03137160

An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum

Results postedJul 18, 2018· ClinicalTrials.gov

Trial results posted: NCT02634801

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis Naive to Systemic Treatment

Trial registeredJun 29, 2018· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT03573323

A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis

Trial startedMay 23, 2018· ClinicalTrials.gov

Phase 2 trial started: NCT03485976

Ixekizumab in the Treatment of Pityriasis Rubra Pilaris (PRP)

Primary completionMay 18, 2018· ClinicalTrials.gov

Phase 3 primary completion: NCT02696798

A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis

FDA approval (supplemental)May 17, 2018· FDA

FDA approved supplemental application for Taltz (ixekizumab) — Efficacy (BLA 125521 S-9)

Sponsor: ELI LILLY AND CO. Class: Efficacy.

Trial startedApr 26, 2018· ClinicalTrials.gov

Phase 3 trial started: NCT03364309

A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis

FDA approval (supplemental)Apr 19, 2018· FDA

FDA approved supplemental application for Taltz (ixekizumab) (BLA 125521 S-2)

Sponsor: ELI LILLY AND CO.

Results postedApr 18, 2018· ClinicalTrials.gov

Trial results posted: NCT02513550

A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis

Trial registeredApr 3, 2018· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT03485976

Ixekizumab in the Treatment of Pityriasis Rubra Pilaris (PRP)

Results postedMar 23, 2018· ClinicalTrials.gov

Trial results posted: NCT02718898

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis

FDA approval (supplemental)Mar 16, 2018· FDA

FDA approved supplemental application for Taltz (ixekizumab) — Labeling (BLA 125521 S-11)

Sponsor: ELI LILLY AND CO. Class: Labeling.

Results postedFeb 28, 2018· ClinicalTrials.gov

Trial results posted: NCT02561806

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis

2017

Results postedDec 14, 2017· ClinicalTrials.gov

Trial results posted: NCT02349295

A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

Primary completionDec 8, 2017· ClinicalTrials.gov

Phase 3 primary completion: NCT02696785

A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis

Trial registeredDec 6, 2017· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03364309

A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis

FDA approval (supplemental)Dec 1, 2017· FDA

FDA approved supplemental application for Taltz (ixekizumab) — Efficacy (BLA 125521 S-4)

Sponsor: ELI LILLY AND CO. Class: Efficacy.

Primary completionNov 21, 2017· ClinicalTrials.gov

Phase 1 primary completion: NCT02993471

A Study of Ixekizumab in Participants With Plaque Psoriasis

Trial startedAug 24, 2017· ClinicalTrials.gov

Phase 4 trial started: NCT03151551

A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis

Trial startedAug 15, 2017· ClinicalTrials.gov

Phase 2 trial started: NCT03099538

Ixekizumab in the Treatment of Bullous Pemphigoid

Results postedJul 25, 2017· ClinicalTrials.gov

Trial results posted: NCT01107457

A Study in Participants With Moderate to Severe Psoriasis

FDA approval (supplemental)Jul 5, 2017· FDA

FDA approved supplemental application for Taltz (ixekizumab) — Labeling (BLA 125521 S-3)

Sponsor: ELI LILLY AND CO. Class: Labeling.

Trial registeredMay 12, 2017· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT03151551

A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis

Trial startedMay 9, 2017· ClinicalTrials.gov

Phase 3 trial started: NCT03129100

A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis

Trial startedMay 4, 2017· ClinicalTrials.gov

Phase 2 trial started: NCT03137160

An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum

Trial registeredMay 2, 2017· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT03137160

An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum

Trial registeredApr 26, 2017· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03129100

A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis

Trial startedApr 13, 2017· ClinicalTrials.gov

Phase 1 trial started: NCT03073213

A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

Trial registeredApr 4, 2017· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT03099538

Ixekizumab in the Treatment of Bullous Pemphigoid

Trial startedMar 28, 2017· ClinicalTrials.gov

Phase 3 trial started: NCT03073200

Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

Trial registeredMar 8, 2017· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03073200

Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

Trial registeredMar 8, 2017· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT03073213

A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

Primary completionFeb 22, 2017· ClinicalTrials.gov

Phase 3 primary completion: NCT02718898

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis

Results postedJan 6, 2017· ClinicalTrials.gov

Trial results posted: NCT02543918

A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants

Pivotal publicationJan 1, 2017· PubMed

Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-we (Lancet)

SPIRIT-P2 — A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

2016

Trial startedDec 22, 2016· ClinicalTrials.gov

Phase 1 trial started: NCT02993471

A Study of Ixekizumab in Participants With Plaque Psoriasis

Trial registeredDec 15, 2016· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT02993471

A Study of Ixekizumab in Participants With Plaque Psoriasis

Primary completionNov 30, 2016· ClinicalTrials.gov

Phase 3 primary completion: NCT02513550

A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis

Primary completionNov 29, 2016· ClinicalTrials.gov

Phase 3 primary completion: NCT02634801

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis Naive to Systemic Treatment

Results postedOct 27, 2016· ClinicalTrials.gov

Trial results posted: NCT01695239

A Study of Ixekizumab in Participants With Active Psoriatic Arthritis

Results postedOct 21, 2016· ClinicalTrials.gov

Trial results posted: NCT01646177

A Study in Participants With Moderate to Severe Psoriasis (UNCOVER-3)

Results postedOct 21, 2016· ClinicalTrials.gov

Trial results posted: NCT02387801

A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis

Results postedOct 20, 2016· ClinicalTrials.gov

Trial results posted: NCT01597245

A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2)

Results postedSep 30, 2016· ClinicalTrials.gov

Trial results posted: NCT01624233

A Study in Japanese Participants With Moderate-to-Severe Psoriasis

Primary completionSep 9, 2016· ClinicalTrials.gov

Phase 3 primary completion: NCT02349295

A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

Trial startedAug 2, 2016· ClinicalTrials.gov

Phase 3 trial started: NCT02757352

A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis

Primary completionMay 31, 2016· ClinicalTrials.gov

Phase 3 primary completion: NCT02561806

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis

Results postedMay 27, 2016· ClinicalTrials.gov

Trial results posted: NCT01474512

A Phase 3 Study in Participants With Moderate to Severe Psoriasis

Results postedMay 26, 2016· ClinicalTrials.gov

Trial results posted: NCT01777191

Evaluation of Ixekizumab Using Auto-Injector or Prefilled Syringe in Participants With Moderate to Severe Plaque Psoriasis

Trial startedMay 2, 2016· ClinicalTrials.gov

Phase 3 trial started: NCT02696785

A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis

Trial registeredMay 2, 2016· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02757352

A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis

Primary completionApr 30, 2016· ClinicalTrials.gov

Phase 3 primary completion: NCT01870284

Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)

Trial startedApr 30, 2016· ClinicalTrials.gov

Phase 3 trial started: NCT02718898

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis

Trial startedApr 12, 2016· ClinicalTrials.gov

Phase 3 trial started: NCT02696798

A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis

Trial registeredMar 24, 2016· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02718898

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis

FDA approvalMar 22, 2016· FDA

FDA approved Taltz (ixekizumab) (BLA 125521)

Sponsor: ELI LILLY AND CO. Class: Type 1 - New Molecular Entity.

Trial registeredMar 2, 2016· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02696785

A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis

Trial registeredMar 2, 2016· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02696798

A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis

Trial startedJan 20, 2016· ClinicalTrials.gov

Phase 3 trial started: NCT02634801

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis Naive to Systemic Treatment

Pivotal publicationJan 1, 2016· PubMed

Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis. (N Engl J Med)

UNCOVER-3 — A Study in Participants With Moderate to Severe Psoriasis (UNCOVER-3)

2015

Trial registeredDec 18, 2015· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02634801

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis Naive to Systemic Treatment

Primary completionNov 30, 2015· ClinicalTrials.gov

Phase 1 primary completion: NCT02543918

A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants

Trial startedOct 31, 2015· ClinicalTrials.gov

Phase 3 trial started: NCT02561806

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis

Trial registeredOct 23, 2015· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02584855

A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

Primary completionSep 30, 2015· ClinicalTrials.gov

Phase 3 primary completion: NCT02387801

A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis

Trial startedSep 30, 2015· ClinicalTrials.gov

Phase 1 trial started: NCT02543918

A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants

Trial registeredSep 28, 2015· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02561806

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis

Trial startedSep 14, 2015· ClinicalTrials.gov

Phase 3 trial started: NCT02584855

A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

Trial registeredSep 7, 2015· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT02543918

A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants

Trial startedAug 31, 2015· ClinicalTrials.gov

Phase 3 trial started: NCT02513550

A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis

Trial registeredJul 31, 2015· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02513550

A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis

Trial startedApr 30, 2015· ClinicalTrials.gov

Phase 3 trial started: NCT02387801

A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis

Trial registeredMar 13, 2015· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02387801

A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis

Trial registeredJan 28, 2015· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02349295

A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

Pivotal publicationJan 1, 2015· PubMed

Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. (Lancet)

UNCOVER-3 — A Study in Participants With Moderate to Severe Psoriasis (UNCOVER-3)

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.