Deucravacitinib History and Updates

179 events · 2021 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 18, 2026.

FDA Approvals

Label Revisions

176

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-17Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Deucravacitinib since 2021, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (14)

2026

Results postedDeucravacitinib Hidradenitis Suppurativa Trial Terminated, Placebo Shows…· May 29, 2026
Primary completionDeucravacitinib Plaque Psoriasis Trial vs. Zasocitinib Completes Primary Phase· Apr 22, 2026
Results postedDeucravacitinib Shows Strong Response in Genital Psoriasis in Phase 4 Trial· Apr 17, 2026
FDA approval (supplemental)Sotyktu (Deucravacitinib) Receives FDA Supplemental Approval for Efficacy· Mar 6, 2026

2025

Results postedDeucravacitinib Trial for Palmoplantar Pustulosis Terminated, No ppPASI-50…· Dec 16, 2025
Results postedDeucravacitinib: Breast Milk and Plasma Concentrations Measured in Lactating…· Dec 3, 2025
Results postedDeucravacitinib Shows Superior ACR 20 Response in Psoriatic Arthritis· Oct 24, 2025
Results postedDeucravacitinib Improves CLASI Activity in Discoid and Subacute Cutaneous Lupus· Sep 10, 2025
Results postedDeucravacitinib Significantly Improves QoL in Plaque Psoriasis Trial· Sep 10, 2025
Results postedDeucravacitinib Phase 2 Trial Shows Response in Lichen Planopilaris· Jun 8, 2025
Results postedDeucravacitinib Phase 3 Trial Improves Psoriatic Arthritis ACR20 and DAS28-CRP· Apr 13, 2025
Results postedDeucravacitinib Shows Significant Improvement in Moderate-to-Severe Scalp…· Mar 13, 2025
Results postedDeucravacitinib Alopecia Areata Trial Shows No Improvement vs. Placebo· Feb 28, 2025
Pivotal publicationDeucravacitinib: ICONIC-ADVANCE 1 & 2 Study Published for Plaque Psoriasis· Jan 1, 2025

Upcoming & expected milestones

Primary completionJun 30, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06725264

Tyrosine Kinase 2 (TYK2) for GA and CS

Primary completionJun 30, 2026· ClinicalTrials.gov

Phase 4 primary completion: NCT05858645

Correction of Psoriatic T Cell Signatures by Deucravacitinib

Primary completionJul 1, 2026· ClinicalTrials.gov

Primary completion: NCT07564271

Clinical Characteristics and Mechanism Research of Deucravacitinib in the Idiopathic Inflammatory Myopathies

Trial startedAug 1, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07352566

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Primary completionAug 30, 2026· ClinicalTrials.gov

Primary completion: NCT06999941

A Real-world Study of Deucravacitinib in the Treatment of Moderate to Severe Plaque Psoriasis With Eczematous Features

Primary completionSep 30, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT07508488

Deucravacitinib in the Treatment of Cicatricial Alopecias

Primary completionOct 19, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05617677

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus

Primary completionOct 19, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05620407

A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupu

Primary completionNov 5, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06327321

Vitiligo Treatment by Targeting TYK2 Mediated Responses

Primary completionNov 18, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05946941

A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome

Primary completionJan 31, 2027· ClinicalTrials.gov

Primary completion: NCT06710470

A Study on the Safety of Deucravacitinib Exposure in Pregnant Women and Their Offspring

Primary completionMar 11, 2027· ClinicalTrials.gov

Primary completion: NCT06512337

A Observational Study to Evaluate Deucravacitinib in Patients With Moderate Plaque Psoriasis in China

Primary completionJul 5, 2027· ClinicalTrials.gov

Primary completion: NCT07256015

Deucravacitinib for Patients With Moderate/Severe Psoriasis: A Real-Life Experience in Italy

Primary completionDec 10, 2027· ClinicalTrials.gov

Primary completion: NCT05744466

A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis

Primary completionDec 15, 2027· ClinicalTrials.gov

Phase 4 primary completion: NCT07280702

Deucravacitinib-TNFi Combination Therapy for Difficult-to-Control Psoriatic Disease

Primary completionDec 31, 2027· ClinicalTrials.gov

Phase 4 primary completion: NCT07013838

The Efficacy and Safety of Deucravacitinib in Takayasu's Arteritis

Primary completionApr 1, 2028· ClinicalTrials.gov

Primary completion: NCT07017699

A Study to Assess Deucravacitinib Safety in Pregnancy

Primary completionApr 30, 2028· ClinicalTrials.gov

Primary completion: NCT06701513

A Real-world Study to Evaluate the Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in France (RePhlect)

Primary completionJun 30, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT07508488

Deucravacitinib in the Treatment of Cicatricial Alopecias

Primary completionJun 30, 2028· ClinicalTrials.gov

Phase 4 primary completion: NCT05858645

Correction of Psoriatic T Cell Signatures by Deucravacitinib

Primary completionSep 30, 2028· ClinicalTrials.gov

Primary completion: NCT06258668

Real-World Safety and Effectiveness of Sotyktu (Deucravacitinib) in Patients With Moderate-to-Severe Plaque Psoriasis in Korea

Primary completionJan 1, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT04772079

A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe

Primary completionOct 12, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT06979453

A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe

Primary completionDec 31, 2029· ClinicalTrials.gov

Primary completion: NCT06382987

A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect)

Primary completionMar 6, 2030· ClinicalTrials.gov

Phase 3 primary completion: NCT06869551

A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic

Primary completionJun 1, 2030· ClinicalTrials.gov

Phase 4 primary completion: NCT07352566

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Primary completionJan 16, 2031· ClinicalTrials.gov

Phase 3 primary completion: NCT07116967

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

Primary completionNov 30, 2031· ClinicalTrials.gov

Primary completion: NCT06952465

A Study Comparing the Risk of Serious Infections and Malignancies With Deucravacitinib or Biologics in Japanese Patients With Psoriasis

Past events

2026

Results postedMay 29, 2026· ClinicalTrials.gov

Trial results posted: NCT05997277

Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo Hidradenitis Suppurativa (HS).

Trial startedMay 11, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07508488

Deucravacitinib in the Treatment of Cicatricial Alopecias

Primary completionMay 5, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06327321

Vitiligo Treatment by Targeting TYK2 Mediated Responses

Trial registeredMay 4, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07564271

Clinical Characteristics and Mechanism Research of Deucravacitinib in the Idiopathic Inflammatory Myopathies

Trial startedApr 30, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07508488

Deucravacitinib in the Treatment of Cicatricial Alopecias

Primary completionApr 22, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06973291

A Study Comparing Zasocitinib (TAK-279) With Deucravacitinib in Adults With Plaque Psoriasis

Results postedApr 17, 2026· ClinicalTrials.gov

Trial results posted: NCT06042920

A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis

Trial startedApr 15, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07280702

Deucravacitinib-TNFi Combination Therapy for Difficult-to-Control Psoriatic Disease

Trial registeredApr 2, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07508488

Deucravacitinib in the Treatment of Cicatricial Alopecias

Primary completionMar 19, 2026· ClinicalTrials.gov

Phase 4 primary completion: NCT06333860

A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasi

FDA approval (supplemental)Mar 6, 2026· FDA

FDA approved supplemental application for Sotyktu (deucravacitinib) — Efficacy (NDA 214958 S-2)

Sponsor: BRISTOL. Class: Efficacy.

Primary completionJan 31, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06532136

Deucravacitinib Rosacea

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 1, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07352566

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

2025

Results postedDec 16, 2025· ClinicalTrials.gov

Trial results posted: NCT05710185

Deucravacitinib for the Treatment of Palmoplantar Pustulosis

Trial registeredDec 12, 2025· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07280702

Deucravacitinib-TNFi Combination Therapy for Difficult-to-Control Psoriatic Disease

Results postedDec 3, 2025· ClinicalTrials.gov

Trial results posted: NCT06476834

A Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants

Trial startedDec 3, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06979453

A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe

Primary completionDec 1, 2025· ClinicalTrials.gov

EARLY_Phase 1 primary completion: NCT05124080

An Investigator Initiated Open Label Study Evaluating the Efficacy and Tolerability of Oral Deucravacitinib for the Treatment of Nail Psoria

Trial registeredDec 1, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07256015

Deucravacitinib for Patients With Moderate/Severe Psoriasis: A Real-Life Experience in Italy

Primary completionNov 30, 2025· ClinicalTrials.gov

NA primary completion: NCT07000630

Efficacy and Tolerability of Deucravacitinib in the Management of Palmoplantar Pustulosis

Results postedOct 24, 2025· ClinicalTrials.gov

Trial results posted: NCT04908202

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)

Trial startedOct 5, 2025· ClinicalTrials.gov

Trial started: NCT07564271

Clinical Characteristics and Mechanism Research of Deucravacitinib in the Idiopathic Inflammatory Myopathies

Primary completionSep 30, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT06136403

A 44-week Monocentric Open Study Assessing the Efficacy and Safety of Deucravacitinib in Adults With Inflammatory Genodermatoses

Trial startedSep 22, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT07116967

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

Results postedSep 10, 2025· ClinicalTrials.gov

Trial results posted: NCT04857034

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus

Results postedSep 10, 2025· ClinicalTrials.gov

Trial results posted: NCT05701995

A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting

Primary completionSep 2, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT06444399

Deucravacitinib (BMS-986165) for Pityriasis Rubra Pilaris

Primary completionAug 18, 2025· ClinicalTrials.gov

Primary completion: NCT06104644

A Study to Evaluate Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis in Germany

Trial registeredAug 12, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07116967

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

Trial startedAug 5, 2025· ClinicalTrials.gov

Trial started: NCT07256015

Deucravacitinib for Patients With Moderate/Severe Psoriasis: A Real-Life Experience in Italy

Trial startedJul 9, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06973291

A Study Comparing Zasocitinib (TAK-279) With Deucravacitinib in Adults With Plaque Psoriasis

Trial startedJun 20, 2025· ClinicalTrials.gov

NA trial started: NCT07000630

Efficacy and Tolerability of Deucravacitinib in the Management of Palmoplantar Pustulosis

Trial startedJun 15, 2025· ClinicalTrials.gov

Phase 4 trial started: NCT07013838

The Efficacy and Safety of Deucravacitinib in Takayasu's Arteritis

Primary completionJun 13, 2025· ClinicalTrials.gov

Phase 1 primary completion: NCT06566768

Study to Evaluate Drug Levels of Various Solid Gastro-retentive Formulations of Deucravacitinib (BMS-986165) in Healthy Participants

Trial registeredJun 12, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07017699

A Study to Assess Deucravacitinib Safety in Pregnancy

Trial registeredJun 10, 2025· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07013838

The Efficacy and Safety of Deucravacitinib in Takayasu's Arteritis

Results postedJun 8, 2025· ClinicalTrials.gov

Trial results posted: NCT06091956

A Study of Deucravacitinib to Treat LPP and FFA

Trial registeredJun 3, 2025· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT07000630

Efficacy and Tolerability of Deucravacitinib in the Management of Palmoplantar Pustulosis

Trial registeredMay 31, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06999941

A Real-world Study of Deucravacitinib in the Treatment of Moderate to Severe Plaque Psoriasis With Eczematous Features

Trial registeredMay 20, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06979453

A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe

Trial registeredMay 15, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06973291

A Study Comparing Zasocitinib (TAK-279) With Deucravacitinib in Adults With Plaque Psoriasis

Trial registeredMay 1, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06952465

A Study Comparing the Risk of Serious Infections and Malignancies With Deucravacitinib or Biologics in Japanese Patients With Psoriasis

Primary completionApr 25, 2025· ClinicalTrials.gov

Phase 4 primary completion: NCT06042920

A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis

Trial startedApr 24, 2025· ClinicalTrials.gov

Trial started: NCT06999941

A Real-world Study of Deucravacitinib in the Treatment of Moderate to Severe Plaque Psoriasis With Eczematous Features

Results postedApr 13, 2025· ClinicalTrials.gov

Trial results posted: NCT04908189

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)

Primary completionApr 4, 2025· ClinicalTrials.gov

Phase 1 primary completion: NCT06851871

A Study to Evaluate the Bioequivalence Between Immediate Release Tablets and Minitablets of Deucravacitinib (BMS-986165), and the Effect of

Trial startedMar 31, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06725264

Tyrosine Kinase 2 (TYK2) for GA and CS

Trial startedMar 21, 2025· ClinicalTrials.gov

Trial started: NCT07017699

A Study to Assess Deucravacitinib Safety in Pregnancy

Primary completionMar 20, 2025· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT06281106

TYK2 Inhibition in Paradoxical Psoriasis

Trial startedMar 13, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06869551

A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic

Results postedMar 13, 2025· ClinicalTrials.gov

Trial results posted: NCT05478499

Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis

Trial registeredMar 11, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06869551

A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic

Trial registeredFeb 28, 2025· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06851871

A Study to Evaluate the Bioequivalence Between Immediate Release Tablets and Minitablets of Deucravacitinib (BMS-986165), and the Effect of

Results postedFeb 28, 2025· ClinicalTrials.gov

Trial results posted: NCT05556265

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata

Primary completionFeb 25, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT05997277

Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo Hidradenitis Suppurativa (HS).

Trial startedJan 29, 2025· ClinicalTrials.gov

Trial started: NCT06701513

A Real-world Study to Evaluate the Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in France (RePhlect)

Trial startedJan 24, 2025· ClinicalTrials.gov

Trial started: NCT06952465

A Study Comparing the Risk of Serious Infections and Malignancies With Deucravacitinib or Biologics in Japanese Patients With Psoriasis

Trial startedJan 23, 2025· ClinicalTrials.gov

Phase 1 trial started: NCT06851871

A Study to Evaluate the Bioequivalence Between Immediate Release Tablets and Minitablets of Deucravacitinib (BMS-986165), and the Effect of

Trial startedJan 20, 2025· ClinicalTrials.gov

Trial started: NCT06512337

A Observational Study to Evaluate Deucravacitinib in Patients With Moderate Plaque Psoriasis in China

Pivotal publicationJan 1, 2025· PubMed

Once-daily oral icotrokinra versus placebo and once-daily oral deucravacitinib in participants with moderate-to-severe plaque psoriasis (ICONIC-ADVANCE 1 & 2): (Lancet)

A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)

2024

Trial registeredDec 10, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06725264

Tyrosine Kinase 2 (TYK2) for GA and CS

Primary completionDec 1, 2024· ClinicalTrials.gov

Phase 4 primary completion: NCT05710185

Deucravacitinib for the Treatment of Palmoplantar Pustulosis

Trial startedNov 30, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06532136

Deucravacitinib Rosacea

Trial registeredNov 29, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06710470

A Study on the Safety of Deucravacitinib Exposure in Pregnant Women and Their Offspring

Trial registeredNov 22, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06701513

A Real-world Study to Evaluate the Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in France (RePhlect)

Primary completionNov 15, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT06220604

A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)

Primary completionNov 2, 2024· ClinicalTrials.gov

Phase 4 primary completion: NCT06476834

A Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants

Trial startedOct 7, 2024· ClinicalTrials.gov

Phase 1 trial started: NCT06566768

Study to Evaluate Drug Levels of Various Solid Gastro-retentive Formulations of Deucravacitinib (BMS-986165) in Healthy Participants

Results postedSep 24, 2024· ClinicalTrials.gov

Trial results posted: NCT04877990

A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis

Primary completionSep 17, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT06143878

A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Primary completionSep 5, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT04908202

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)

Primary completionAug 23, 2024· ClinicalTrials.gov

Phase 4 primary completion: NCT05701995

A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting

Primary completionAug 22, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT04857034

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus

Trial registeredAug 22, 2024· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06566768

Study to Evaluate Drug Levels of Various Solid Gastro-retentive Formulations of Deucravacitinib (BMS-986165) in Healthy Participants

Trial startedAug 21, 2024· ClinicalTrials.gov

Trial started: NCT06258668

Real-World Safety and Effectiveness of Sotyktu (Deucravacitinib) in Patients With Moderate-to-Severe Plaque Psoriasis in Korea

Trial startedAug 2, 2024· ClinicalTrials.gov

Trial started: NCT06710470

A Study on the Safety of Deucravacitinib Exposure in Pregnant Women and Their Offspring

Trial registeredAug 1, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06532136

Deucravacitinib Rosacea

Trial startedJul 29, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06444399

Deucravacitinib (BMS-986165) for Pityriasis Rubra Pilaris

Trial registeredJul 22, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06512337

A Observational Study to Evaluate Deucravacitinib in Patients With Moderate Plaque Psoriasis in China

Trial registeredJun 26, 2024· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06476834

A Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants

Trial startedJun 24, 2024· ClinicalTrials.gov

Phase 4 trial started: NCT06476834

A Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants

Trial startedJun 20, 2024· ClinicalTrials.gov

Phase 2/Phase 3 trial started: NCT06281106

TYK2 Inhibition in Paradoxical Psoriasis

Trial registeredJun 5, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06444399

Deucravacitinib (BMS-986165) for Pityriasis Rubra Pilaris

Primary completionMay 21, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT06091956

A Study of Deucravacitinib to Treat LPP and FFA

Trial startedMay 10, 2024· ClinicalTrials.gov

Phase 4 trial started: NCT06333860

A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasi

Trial startedMay 5, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06327321

Vitiligo Treatment by Targeting TYK2 Mediated Responses

Primary completionApr 29, 2024· ClinicalTrials.gov

EARLY_Phase 1 primary completion: NCT05821374

Deucravacitinib in PG

Trial startedApr 29, 2024· ClinicalTrials.gov

EARLY_Phase 1 trial started: NCT05821374

Deucravacitinib in PG

Trial registeredApr 25, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06382987

A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect)

Trial registeredMar 27, 2024· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06333860

A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasi

Trial registeredMar 25, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06327321

Vitiligo Treatment by Targeting TYK2 Mediated Responses

Trial registeredMar 25, 2024· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06329258

Combination of Sotyktu and Enstilar for Plaque Psoriasis

Trial startedMar 18, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06136403

A 44-week Monocentric Open Study Assessing the Efficacy and Safety of Deucravacitinib in Adults With Inflammatory Genodermatoses

Trial startedMar 9, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06220604

A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)

Trial startedMar 1, 2024· ClinicalTrials.gov

EARLY_Phase 1 trial started: NCT05124080

An Investigator Initiated Open Label Study Evaluating the Efficacy and Tolerability of Oral Deucravacitinib for the Treatment of Nail Psoria

Trial registeredFeb 28, 2024· ClinicalTrials.gov

Phase 2/Phase 3 trial registered on ClinicalTrials.gov: NCT06281106

TYK2 Inhibition in Paradoxical Psoriasis

Trial registeredFeb 14, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06258668

Real-World Safety and Effectiveness of Sotyktu (Deucravacitinib) in Patients With Moderate-to-Severe Plaque Psoriasis in Korea

Primary completionFeb 6, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT04908189

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)

Trial startedFeb 1, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06143878

A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Trial registeredJan 24, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06220604

A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)

Trial startedJan 22, 2024· ClinicalTrials.gov

Trial started: NCT06382987

A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect)

Primary completionJan 11, 2024· ClinicalTrials.gov

Phase 4 primary completion: NCT05478499

Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis

Primary completionJan 6, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT05556265

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata

2023

Trial startedNov 30, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05997277

Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo Hidradenitis Suppurativa (HS).

Trial registeredNov 22, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06143878

A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Trial registeredNov 18, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06136403

A 44-week Monocentric Open Study Assessing the Efficacy and Safety of Deucravacitinib in Adults With Inflammatory Genodermatoses

Primary completionNov 13, 2023· ClinicalTrials.gov

Phase 4 primary completion: NCT06329258

Combination of Sotyktu and Enstilar for Plaque Psoriasis

Trial startedNov 7, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT06091956

A Study of Deucravacitinib to Treat LPP and FFA

Trial registeredOct 27, 2023· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06104644

A Study to Evaluate Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis in Germany

Trial registeredOct 23, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06091956

A Study of Deucravacitinib to Treat LPP and FFA

Trial startedOct 9, 2023· ClinicalTrials.gov

Phase 4 trial started: NCT06042920

A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis

Trial startedOct 1, 2023· ClinicalTrials.gov

Phase 4 trial started: NCT05858645

Correction of Psoriatic T Cell Signatures by Deucravacitinib

Trial registeredSep 21, 2023· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06042920

A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis

Trial startedSep 11, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05946941

A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome

Primary completionAug 29, 2023· ClinicalTrials.gov

Phase 2 primary completion: NCT04877990

A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis

Trial registeredAug 18, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05997277

Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo Hidradenitis Suppurativa (HS).

Trial registeredJul 14, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05946941

A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome

Trial startedJul 1, 2023· ClinicalTrials.gov

Phase 4 trial started: NCT05710185

Deucravacitinib for the Treatment of Palmoplantar Pustulosis

Trial registeredMay 15, 2023· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05858645

Correction of Psoriatic T Cell Signatures by Deucravacitinib

Trial registeredApr 20, 2023· ClinicalTrials.gov

EARLY_Phase 1 trial registered on ClinicalTrials.gov: NCT05821374

Deucravacitinib in PG

Trial startedApr 13, 2023· ClinicalTrials.gov

Trial started: NCT06104644

A Study to Evaluate Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis in Germany

Trial registeredFeb 27, 2023· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT05744466

A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis

Trial registeredFeb 2, 2023· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05710185

Deucravacitinib for the Treatment of Palmoplantar Pustulosis

Trial startedJan 31, 2023· ClinicalTrials.gov

Phase 4 trial started: NCT05701995

A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting

Trial registeredJan 27, 2023· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05701995

A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting

Trial startedJan 12, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05617677

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus

Trial startedJan 12, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05620407

A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupu

2022

Trial startedDec 6, 2022· ClinicalTrials.gov

Phase 4 trial started: NCT06329258

Combination of Sotyktu and Enstilar for Plaque Psoriasis

Trial registeredNov 17, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05620407

A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupu

Trial registeredNov 15, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05617677

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus

Trial startedNov 8, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05556265

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata

Trial startedOct 6, 2022· ClinicalTrials.gov

Phase 4 trial started: NCT05478499

Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis

Trial startedSep 30, 2022· ClinicalTrials.gov

Trial started: NCT05744466

A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis

Trial registeredSep 27, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05556265

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata

FDA approvalSep 9, 2022· FDA

FDA approved Sotyktu (deucravacitinib) (NDA 214958)

Sponsor: BRISTOL. Class: Type 1 - New Molecular Entity.

Trial registeredJul 28, 2022· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05478499

Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis

Primary completionJan 3, 2022· ClinicalTrials.gov

Phase 1 primary completion: NCT04949269

A Study to Evaluate the Drug Levels of Deucravacitinib From Tablets After Oral Administration in Healthy Participants

2021

Trial registeredNov 17, 2021· ClinicalTrials.gov

EARLY_Phase 1 trial registered on ClinicalTrials.gov: NCT05124080

An Investigator Initiated Open Label Study Evaluating the Efficacy and Tolerability of Oral Deucravacitinib for the Treatment of Nail Psoria

Trial startedJul 20, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT04949269

A Study to Evaluate the Drug Levels of Deucravacitinib From Tablets After Oral Administration in Healthy Participants

Trial startedJul 15, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT04908189

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)

Trial startedJul 13, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT04908202

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)

Trial startedJul 12, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04857034

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus

Trial registeredJul 2, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04949269

A Study to Evaluate the Drug Levels of Deucravacitinib From Tablets After Oral Administration in Healthy Participants

Trial registeredJun 1, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04908189

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)

Trial registeredJun 1, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04908202

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)

Trial registeredMay 7, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04877990

A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis

Trial startedMay 7, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04877990

A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis

Trial registeredApr 23, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04857034

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus

Trial startedMar 23, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT04772079

A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psorias

Trial registeredFeb 26, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04772079

A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psorias

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.