A Long-term Extension Study of JNJ-77242113 in Participants With Moderate-to-Severe Plaque Psoriasis

NCT05364554 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: CR1091552021-004320-1677242113PSO2002
• Study Type: interventional
• Target: 227
• Locations: 10 countries
• Sites: 60

Brief Summary

The purpose of this study is to evaluate long-term clinical response of JNJ-77242113 treatment in participants with moderate-to-severe plaque psoriasis.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 36

  Percentage of participants achieving PASI 75 score (greater than or equal to \[\>=\] 75 percent \[%\] improvement in PASI from baseline of the originating study \[77242113PSO2001\]) at Week 36 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.

  Week 36

Secondary Outcomes (10)

• Percentage of Participants Achieving PASI 90 Score at Week 36

  Week 36

• Percentage of Participants Achieving PASI 100 Score at Week 36

  Week 36

• Change From Baseline in PASI Total Score at Week 36

  Baseline and Week 36

• Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 36

  Week 36

• Change from Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 36

  Baseline and Week 36

Study Arms (6)

Group 1: JNJ-77242113 Dose 1 Once Daily (QD)

EXPERIMENTAL

Participants originally randomized to JNJ-77242113 Dose 1 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 QD from Week 0 through Week 36 in this study.

Drug: JNJ-77242113

Group 2: JNJ-77242113 Dose 2 QD

EXPERIMENTAL

Participants originally randomized to JNJ-77242113 Dose 2 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 2 QD from Week 0 through Week 36 in this study.

Drug: JNJ-77242113

Group 3: JNJ-77242113 Dose 3 QD

EXPERIMENTAL

Participants originally randomized to JNJ-77242113 Dose 3 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study.

Drug: JNJ-77242113

Group 4: JNJ-77242113 Dose 1 Twice Daily (BID)

EXPERIMENTAL

Participants originally randomized to JNJ-77242113 Dose 1 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 BID from Week 0 through Week 36 in this study.

Drug: JNJ-77242113

Group 5: JNJ-77242113 Dose 3 BID

EXPERIMENTAL

Participants originally randomized to JNJ-77242113 Dose 3 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 BID from Week 0 through Week 36 in this study.

Drug: JNJ-77242113

Group 6: JNJ-77242113 Dose 3 QD

EXPERIMENTAL

Participants originally randomized to placebo in originating Study 77242113PSO2001 will receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study.

Drug: JNJ-77242113

Interventions

JNJ-77242113 DRUG

JNJ-77242113 tablet will be administered orally.

Group 1: JNJ-77242113 Dose 1 Once Daily (QD); Group 2: JNJ-77242113 Dose 2 QD; Group 3: JNJ-77242113 Dose 3 QD; Group 4: JNJ-77242113 Dose 1 Twice Daily (BID); Group 5: JNJ-77242113 Dose 3 BID; Group 6: JNJ-77242113 Dose 3 QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have completed the Week 16 visit in Protocol 77242113PSO2001
• Must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study
• Must agree to discontinue all topical therapies that could affect psoriasis or the psoriasis area severity index (PASI) or investigator's global assessment (IGA) evaluation, other than nonmedicated emollient and salicylic acid shampoos, prior to first administration of study intervention
• Agree not to receive a live virus or live bacterial vaccination during the study, or within 4 weeks after the last administration of study intervention

You may not qualify if:

• Was permanently discontinued from study intervention in Protocol 77242113PSO2001 for any reason
• Has received any biologic therapy or experimental therapy since completion of the originating study, 77242113PSO2001
• Has received any live virus or bacterial vaccination within 12 weeks before the first administration of study intervention
• Has received the bacille Calmette-Guerin (BCG) vaccine within 12 months of the first administration of study intervention
• Currently has hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or has other clinically active liver disease, or tests positive for HBsAg or anti-HCV

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (60)

Pacific Skin Institute

Sacramento, California, 95815, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Forcare Clinical Research Inc

Tampa, Florida, 33613, United States

Location

Arlington Dermatology

Rolling Meadows, Illinois, 60008, United States

Location

Indiana Clinical Trial Center

Plainfield, Indiana, 46168, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Vivida Dermatology

Las Vegas, Nevada, 89119, United States

Location

Windsor Dermatology, PC

East Windsor, New Jersey, 08520, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

University of Pittsburgh Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

Location

Modern Research Associates

Dallas, Texas, 75231, United States

Location

Center for Clinical Studies

Houston, Texas, 77004, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

Dermatrials Research

Hamilton, Ontario, L8N 1Y2, Canada

Location

Alliance Clinical Trials

Waterloo, Ontario, N2J 1C4, Canada

Location

XLR8 Medical Research

Windsor, Ontario, N8T 1E6, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2H2B5, Canada

Location

Centre Hospitalier Le Mans

Le Mans, 72037, France

Location

Hopital Charles Nicolle

Rouen, 76031, France

Location

HIA Sainte Anne

Toulon, 83800, France

Location

Fachklinik Bad Bentheim

Bad Bentheim, 48455, Germany

Location

ISA - Interdisciplinary Study Association GmbH

Berlin, 10789, Germany

Location

CRS Clinical Research Services Berlin GmbH

Berlin, 13627, Germany

Location

Niesmann & Othlinghaus GbR

Bochum, 44793, Germany

Location

Rosenpark Research GmbH

Darmstadt, 64283, Germany

Location

Universitatsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

Derma-Study-Center Friedrichshafen GmbH

Friedrichshafen, 88045, Germany

Location

MensingDerma research GmbH

Hamburg, 22391, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitatsklinikum Schleswig Holstein Kiel

Kiel, 24105, Germany

Location

Gemeinschaftspraxis Scholz/Sebastian/Schilling

Mahlow, 15831, Germany

Location

Hautarztpraxis

Witten, 58453, Germany

Location

Takagi Dermatological Clinic

Obihiro-shi, 080-0013, Japan

Location

Kume Clinic

Sakai, 593 8324, Japan

Location

Sapporo Skin Clinic

Sapporo, 060-0063, Japan

Location

Shizuoka General Hospital

Shizuoka, 420-8527, Japan

Location

Shirasaki Dermatology Clinic

Takaoka, 933-0871, Japan

Location

Toyama Prefectural Central Hospital

Toyama, 930 8550, Japan

Location

Nomura Dermatology Clinic

Yokohama, 221 0825, Japan

Location

Nzoz Zdrowie Osteo-Medic

Bialystok, 15-351, Poland

Location

Dermed Centrum Medyczne Sp z o o

Lodz, 90-265, Poland

Location

Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C

Osielsko, 86031, Poland

Location

Klinika Ambroziak Estederm Sp. z o.o

Warsaw, 02-953, Poland

Location

Wro Medica

Wroclaw, 51-685, Poland

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

KyungHee University Hospital

Seoul, 102-1703, South Korea

Location

Hosp. Univ. Germans Trias I Pujol

Barcelona, 08916, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp. Univ. I Politecni La Fe

Valencia, 46026, Spain

Location

Hosp. de Manises

Valencia, 46940, Spain

Location

Chang Gung Memorial Hospital

Kaohsiung City, 83342, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Chang-Gung Memorial Hospital, LinKou Branch

Taoyuan District, 333, Taiwan

Location

Guys and St Thomas NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (2)

• Strawn D, Krueger JG, Bissonnette R, Eyerich K, Ferris LK, Paller AS, Pinter A, Richards D, Chen EY, Paget K, Horowitz D, Parast R, Rusbuldt JJ, Sendecki J, Bhagat S, Tomsho LP, Chou CH, Polak ME, Keyes BE, Bozenhardt E, Xiong Y, Zhou W, DeKlotz C, Newbold P, Waterworth DM, Miller M, Ota T, Yang YW, Leung MW, Miller LS, Cuff CA, McRae B, Ruane D, Kannan AK. Icotrokinra induces early and sustained pharmacodynamic responses in phase IIb study of patients with moderate-to-severe psoriasis. JCI Insight. 2025 Dec 22;10(24):e193563. doi: 10.1172/jci.insight.193563. eCollection 2025 Dec 22.

  PMID: 41424381 DERIVED

• LaRoche JK, Lanier J, Alvarenga R, Collins M, Costelloe T, Chiau A, Whetherly H, De Soete W, Faludi J, Rens K. Climate footprint of industry-sponsored in-human clinical trials: life cycle assessments of clinical trials spanning multiple phases and disease areas. BMJ Open. 2025 Feb 19;15(2):e085364. doi: 10.1136/bmjopen-2024-085364.

  PMID: 39971605 DERIVED

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 6, 2022
• Study Start: June 10, 2022
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

JP (7); GB (2); US (14); FR (3); DE (12); ES (4); CA (4); KR (5); PL (5); TW (4)