A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis

NCT06934226 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 77242113PSO30062024-515706-77-00
• Study Type: interventional
• Target: 752
• Locations: 12 countries
• Sites: 152

Brief Summary

The main purpose of this study is to assess how well JNJ-77242113 works when compared to placebo and ustekinumab in participants with moderate to severe plaque psoriasis.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• JNJ-77242113 and Placebo Group: Percentage of Participants with Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater than or Equal to (>=) 2 Grade Improvement from Baseline at Week 16

  IGA score is given based on the investigator's assessment of the participant's plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's plaque psoriasis is assessed as: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

  Week 16

• JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16

  PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this 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 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants achieving at least a 90 percent improvement from baseline in the PASI score.

  Week 16

Secondary Outcomes (24)

• JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 75 Response at Week 16

  Week 16

• JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 100 Response at Week 16

  Week 16

• JNJ-77242113 and Placebo Group: Percentage of Participants with IGA Score of 0 at Week 16

  Week 16

• JNJ-77242113 and Ustekinumab Group: Percentage of Participants with IGA Score of 0 at Week 28

  Week 28

• JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 90 Response at Week 28

  Week 28

Study Arms (3)

Arm 1: JNJ 77242113

EXPERIMENTAL

Participants will receive JNJ-77242113 once daily from Week 0 through Week 104. All participant will receive ustekinumab matching placebo at Week 0, 4 and 16 to maintain the blind.

Drug: JNJ-77242113; Drug: Matching Placebo to Ustekinumab

Arm 2: Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for ustekinumab at Week 0, 4 and 16 and JNJ-77242113 from Week 16 through Week 104.

Drug: JNJ-77242113; Drug: Matching Placebo to JNJ-77242113; Drug: Matching Placebo to Ustekinumab

Arm 3: Ustekinumab

ACTIVE COMPARATOR

Participants will receive Ustekinumab at Week 0, Week 4, and Week 16 followed by JNJ-77242113 once daily from Week 28 through Week 104. Participants will receive both Ustekinumab and placebo for JNJ-77242113 to maintain the blind through Week 28.

Drug: JNJ-77242113; Drug: Matching Placebo to JNJ-77242113; Drug: Ustekinumab

Interventions

JNJ-77242113 DRUG

JNJ-77242113 will be administered orally.

Arm 1: JNJ 77242113; Arm 2: Placebo; Arm 3: Ustekinumab

Matching Placebo to JNJ-77242113 DRUG

Matching placebo will be administered orally.

Arm 2: Placebo; Arm 3: Ustekinumab

Ustekinumab DRUG

Ustekinumab will be administered subcutaneously.

Also known as: STELARA, CNTO 1275

Arm 3: Ustekinumab

Matching Placebo to Ustekinumab DRUG

Matching placebo will be administered subcutaneously.

Arm 1: JNJ 77242113; Arm 2: Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), prior to the first administration of study intervention
• Total body surface area (BSA) greater than or equal to (\>=)10 percent (%) at screening and baseline
• Total psoriasis area and severity index (PASI) \>=12 at screening and baseline
• Total investigator global assessment (IGA) \>=3 at screening and baseline
• Candidate for phototherapy or systemic treatment for plaque psoriasis

You may not qualify if:

• Nonplaque form of psoriasis (for example \[e.g.\], erythrodermic, guttate, or pustular)
• Current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
• Known allergies, hypersensitivity, or intolerance to JNJ-77242113, ustekinumab, or its excipients
• Major surgical procedure within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study
• Transplanted organ (with exception of a corneal transplant greater than \[\>\] 12 weeks before the first administration of study intervention)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (160)

Cahaba Research Inc

Birmingham, Alabama, 35244, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

T Joseph Raoof Md Inc

Encino, California, 91436, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Dermatologist Medical Group of North County, Inc.

Oceanside, California, 92056, United States

Location

NorCal Clinical Research

Rocklin, California, 95765, United States

Location

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

MedDerm Associates

San Diego, California, 92103, United States

Location

Southern California Dermatology

Santa Ana, California, 92701, United States

Location

Olive View-UCLA Education & Research Institute

Sylmar, California, 91342, United States

Location

University of Conn Health Center

Farmington, Connecticut, 06030, United States

Location

Driven Research LLC

Coral Gables, Florida, 33134, United States

Location

Bioclinical Research Alliance Inc.

Miami, Florida, 33155, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Forcare Clinical Research Inc

Tampa, Florida, 33613, United States

Location

Hamilton Research LLC

Alpharetta, Georgia, 30022, United States

Location

Northshore Medical Group

Skokie, Illinois, 60076, United States

Location

Indiana Clinical Trial Center

Plainfield, Indiana, 46168, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Equity Medical

Bowling Green, Kentucky, 42104, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135, United States

Location

The Derm Institute of West Michigan

Caledonia, Michigan, 49316, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Somerset Skin Centre

Troy, Michigan, 48084, United States

Location

Minnesota Clinical Study Center

New Brighton, Minnesota, 55112, United States

Location

Cleaver Dermatology

Kirksville, Missouri, 63501, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Mount Sinai Doctors Dermatology

New York, New York, 10028, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

Wilmington Dermatology Center

Wilmington, North Carolina, 28405, United States

Location

Optima Research

Boardman, Ohio, 44512, United States

Location

Apex Dermatology Mayfield Heights

Mayfield Heights, Ohio, 44124, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97201, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Clinical Research Philadelphia

Philadelphia, Pennsylvania, 19114, United States

Location

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Advanced Research Experts PLLC

Nashville, Tennessee, 37211, United States

Location

Arlington Research Center, Inc.

Arlington, Texas, 76011, United States

Location

Modern Research Associates PLLC

Dallas, Texas, 75231, United States

Location

Center for Clinical Studies 1

Houston, Texas, 77004, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

Kalo Clinical Research

West Valley City, Utah, 84120, United States

Location

Frontier Derm Partners CRO, LLC

Mill Creek, Washington, 98012, United States

Location

Consultora Integral de Salud SRL

Barrio Gral Paz Cba Capital, X5000, Argentina

Location

Instituto Medico De Alta Complejidad (IMAC)

Buenos Aires, B1643CRO, Argentina

Location

Mindout Research

Buenos Aires, C1417EYG, Argentina

Location

Instituto de Neumonologia y Dermatologia

Buenos Aires, C1425, Argentina

Location

Buenos Aires Skin

CABA, C1055AAO, Argentina

Location

Investigaciones Medicas IMOBA SRL

CABA, C1056ABH, Argentina

Location

CIPREC

CABA, C1061AAS, Argentina

Location

Halitus Instituto Medico S.A. - Dermatologia y Estetica

Caba, C1122AAF, Argentina

Location

Mautalen Salud e Investigacion

CABA, C1128, Argentina

Location

Hospital Italiano de Buenos Aires

CABA, C1199ABB, Argentina

Location

Instituto De Especialidades De La Salud SRL

Rosario, S2000DBS, Argentina

Location

MR Medicina Reumatologica

San Fernando, B1646, Argentina

Location

Instituto de Investigaciones Medicas Tucuman

San Miguel de Tucumán, T4000, Argentina

Location

Monash Medical Centre

Clayton, 3168, Australia

Location

Cornerstone Dermatology

Coorparoo, 4151, Australia

Location

Premier Specialists

Kogarah, 2217, Australia

Location

The Alfred Hospital

Melbourne, 3004, Australia

Location

Royal Melbourne Hospital

Melbourne, 3050, Australia

Location

ISHI dermatology

Mitcham, 3132, Australia

Location

Westmead Hospital

Westmead, 2145, Australia

Location

Veracity Clinical Research

Woolloongabba, 4102, Australia

Location

LKH Feldkirch

Feldkirch, 6800, Austria

Location

Kepler Universitatsklinikum GmbH

Linz, 4020, Austria

Location

Universtitatsklinikum St Polten

Sankt Pölten, 3100, Austria

Location

Allgemeines Krankenhaus der Stadt Wien

Vienna, 1090, Austria

Location

UZ Brussel

Brussels, 1090, Belgium

Location

AZ St. Lucas

Ghent, 9000, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

Universitair Ziekenhuis Leuven

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

Liège, 4000, Belgium

Location

Dermatologie Maldegem

Maldegem, 9990, Belgium

Location

Skincare Studio Inc Dermatology Clinical Trials

St. John's, Newfoundland and Labrador, A1E 1V4, Canada

Location

CCA Medical Research Corporation

Ajax, Ontario, L1S7K8, Canada

Location

SimcoDerm Medical and Surgical Dermatology Centre

Barrie, Ontario, L4M 7G1, Canada

Location

Dermatrials Research

Hamilton, Ontario, L8N 1Y2, Canada

Location

Lovegrove Dermatology

London, Ontario, N6A 5R9, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X3, Canada

Location

Alliance Clinical Trials

Waterloo, Ontario, N2J 1C4, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

Location

The Centre de recherche Saint-Louis

Québec, Quebec, G1W 4R4, Canada

Location

Aalborg Sygehus Syd

Aalborg, 9100, Denmark

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Gentofte Hospital

Hellerup, 2900, Denmark

Location

Bispebjerg Hospital

København NV, 2400, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Sjællands University hospital

Roskilde, 4000, Denmark

Location

Klinikum Augsburg

Augsburg, 86179, Germany

Location

Fachklinik Bad Bentheim

Bad Bentheim, 48455, Germany

Location

ISA - Interdisciplinary Study Association GmbH

Berlin, 10789, Germany

Location

Universitatsklinikum Bonn

Bonn, 53127, Germany

Location

Studienzentrum an der Hase GbR

Bramsche, 49565, Germany

Location

Rosenpark Research GmbH

Darmstadt, 64283, Germany

Location

Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

Dresden, 01307, Germany

Location

Derma-Study-Center Friedrichshafen GmbH

Friedrichshafen, 88045, Germany

Location

Universitaetsklinikum Schleswig Holstein Campus Kiel

Kiel, 24105, Germany

Location

Studienzentrum Dr Schwarz Germany

Langenau, 89129, Germany

Location

Dermatologie Mahlow

Mahlow, 15831, Germany

Location

Gemeinschaftspraxis Dres. Quist

Mainz, 55128, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

Hautarztpraxis

Witten, 58453, Germany

Location

Obudai Egeszsegugyi Centrum Kft

Budapest, 1036, Hungary

Location

Uno Medical Trials Ltd.

Budapest, 1152, Hungary

Location

Derma-B Kft

Debrecen, 4031, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

Gyongyosi Bugat Pal Korhaz

Gyöngyös, 3200, Hungary

Location

Synexus Magyarorszag Kft

Gyula, 5700, Hungary

Location

Porcika Klinika - Vasarhelyi Sarkanyfu Kft.

Hódmezővásárhely, 6800, Hungary

Location

Somogy Varmegyei Kaposi Mor Oktato Korhaz

Kaposvár, 7400, Hungary

Location

Bacs-kiskun Megyei Korhaz

Kecskemét, 6000, Hungary

Location

Allergo-Derm Bakos Kft.

Szolnok, 5000, Hungary

Location

Medmare Egeszsegugyi Es Szolgaltato Bt.

Veszprém, 8200, Hungary

Location

Specderm Poznanska sp j

Bialystok, 15 375, Poland

Location

Osteo-Medic s.c A. Racewicz, J Supronik

Bialystok, 15-351, Poland

Location

Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

Elblag, 82 300, Poland

Location

Care Clinic Sp z o o

Katowice, 40 568, Poland

Location

Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna

Krakow, 30 002, Poland

Location

Dermed Centrum Medyczne Sp z o o

Lodz, 90-265, Poland

Location

Etyka Osrodek Badan Klinicznych

Olsztyn, 10-117, Poland

Location

SOLUMED Centrum Medyczne

Poznan, 60 529, Poland

Location

Velocity Nova Sp z o o

Skierniewice, 96 100, Poland

Location

Magdalena Opadczuk Carpe Diem Centrum Medycyny Estetycznej

Warsaw, 02 661, Poland

Location

Klinika Ambroziak Dermatologia

Warsaw, 02 953, Poland

Location

WroMedica

Wroclaw, 51 685, Poland

Location

Centrum Medyczne Oporow

Wroclaw, 52 416, Poland

Location

Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes

Guimarães, 4835 044, Portugal

Location

Unidade Local De Saude Da Regiao De Leiria Epe

Leiria, 2410 197, Portugal

Location

Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos

Lisbon, 1169 050, Portugal

Location

Hosp. Cuf Descobertas

Lisbon, 1998 018, Portugal

Location

Ulssa Hosp. Santo Antonio

Porto, 4099 001, Portugal

Location

Hosp. Gral. Univ. Dr. Balmis

Alicante, 03010, Spain

Location

Hosp. Univ. de Cruces

Barakaldo, 48902, Spain

Location

Hosp. Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hosp. Univ. San Cecilio

Granada, 18016, Spain

Location

Grupo Dermatologico Y Estetico Pedro Jaen

Madrid, 28002, Spain

Location

Hosp. Univ. de La Princesa

Madrid, 28006, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp. de Manises

Manises, 46940, Spain

Location

Hosp. Clinico Univ. de Santiago

Santiago Compostela, 15706, Spain

Location

Hosp. Virgen Macarena

Seville, 41009, Spain

Location

Hosp. Ntra. Sra. de Valme

Seville, 41014, Spain

Location

Hosp. Univ. I Politecni La Fe

Valencia, 46026, Spain

Location

Hosp. de La Marina Baixa

Villajoyosa, 03570, Spain

Location

Hosp. Clinico Univ. Lozano Blesa

Zaragoza, 50009, Spain

Location

Hosp. Univ. Miguel Servet

Zaragoza, 50009, Spain

Location

Dudley Group NHS Foundation Trust

Dudley, DY1 2HQ, United Kingdom

Location

London North West University Healthcare NHS Trust

Harrow, HA1 3UJ, United Kingdom

Location

The Queen Elizabeth Hospital NHS Foundation Trust

Kings Lynn, PE30 4ET, United Kingdom

Location

Guys and St Thomas NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

Royal Berkshire Hospital

Reading, RG1 5AN, United Kingdom

Location

Salford Royal Hospital

Salford, M6 8HD, United Kingdom

Location

University Hospital Southampton

Southampton, So166yd, United Kingdom

Location

Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital

Wakefield, WF1 4DG, United Kingdom

Location

MeSH Terms

Interventions

Ustekinumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: April 15, 2025
• Primary Completion: November 17, 2025
• Study Completion (Estimated): August 20, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

HU (11); PT (5); AU (4); BE (6); GB (8); US (48); ES (15); DE (14); CA (9); DK (6); AR (13); PL (13)