77242113PSO3006: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Ustekinumab Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ 77242113 for the Treatment of Participants With Moderate to Severe Plaque Ps
| Registry | NCT06934226, acronym ICONIC-ASCEND |
|---|---|
| Status | Active not recruiting |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 752 (Actual) |
| Sponsor | Janssen Research & Development, LLC (Industry) |
| Conditions | Plaque Psoriasis |
| Interventions | JNJ-77242113, Matching Placebo to JNJ-77242113, Ustekinumab, Matching Placebo to Ustekinumab (Drug) |
| Dates | start 2025-04-15, primary completion 2025-11-17, completion 2027-08-20 (estimated), first posted 2025-04-18, last updated 2026-09-25 |
| Locations | 160 sites in United States, Argentina, Australia, Austria, Belgium, Canada, Denmark, Germany and 5 more countries |
Related Papers Related Patents Related Grants Related Experts
All trials for Plaque Psoriasis All trials of JNJ-77242113 All trials of Matching Placebo to JNJ-77242113
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm 1: JNJ 77242113 | Experimental | Drug: JNJ-77242113; Drug: Matching Placebo to Ustekinumab | 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. |
| Arm 2: Placebo | Placebo comparator | Drug: JNJ-77242113; Drug: Matching Placebo to JNJ-77242113; Drug: Matching Placebo to Ustekinumab | 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. |
| Arm 3: Ustekinumab | Active comparator | Drug: JNJ-77242113; Drug: Matching Placebo to JNJ-77242113; Drug: Ustekinumab | 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. |
Sex: All, ages: 12 Years to any
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
| Facility | City | Country | Status |
|---|---|---|---|
| Cahaba Research Inc | Birmingham, Alabama | United States | |
| California Dermatology & Clinical Research Institute | Encinitas, California | United States | |
| T Joseph Raoof Md Inc | Encino, California | United States | |
| First OC Dermatology | Fountain Valley, California | United States | |
| Dermatologist Medical Group of North County, Inc. | Oceanside, California | United States | |
| NorCal Clinical Research | Rocklin, California | United States | |
| Integrative Skin Science and Research | Sacramento, California | United States | |
| MedDerm Associates | San Diego, California | United States | |
| Southern California Dermatology | Santa Ana, California | United States | |
| Olive View-UCLA Education & Research Institute | Sylmar, California | United States | |
| University of Conn Health Center | Farmington, Connecticut | United States | |
| Driven Research LLC | Miami, Florida | United States | |
| Bioclinical Research Alliance Inc. | Miami, Florida | United States | |
| Renstar Medical Research | Ocala, Florida | United States | |
| Forcare Clinical Research Inc | Tampa, Florida | United States | |
| Hamilton Research LLC | Alpharetta, Georgia | United States | |
| Northshore Medical Group | Skokie, Illinois | United States | |
| Indiana Clinical Trial Center | Plainfield, Indiana | United States | |
| University of Iowa | Iowa City, Iowa | United States | |
| Equity Medical | Bowling Green, Kentucky | United States | |
| Tufts Medical Center | Boston, Massachusetts | United States | |
| Metro Boston Clinical Partners | Brighton, Massachusetts | United States | |
| The Derm Institute of West Michigan | Caledonia, Michigan | United States | |
| Henry Ford Hospital | Detroit, Michigan | United States | |
| Hamzavi Dermatology | Fort Gratiot, Michigan | United States | |
| Somerset Skin Centre | Troy, Michigan | United States | |
| Minnesota Clinical Study Center | New Brighton, Minnesota | United States | |
| Cleaver Dermatology | Kirksville, Missouri | United States | |
| MediSearch Clinical Trials | Saint Joseph, Missouri | United States | |
| Mount Sinai Doctors Dermatology | New York, New York | United States | |
| Sadick Research Group | New York, New York | United States | |
| Wilmington Dermatology Center | Wilmington, North Carolina | United States | |
| Optima Research | Boardman, Ohio | United States | |
| Apex Dermatology Mayfield Heights | Mayfield Heights, Ohio | United States | |
| Oregon Medical Research Center | Portland, Oregon | United States | |
| Oregon Dermatology and Research Center | Portland, Oregon | United States | |
| Clinical Research Philadelphia | Philadelphia, Pennsylvania | United States | |
| UPMC Department of Dermatology | Pittsburgh, Pennsylvania | United States | |
| Health Concepts | Rapid City, South Dakota | United States | |
| Advanced Research Experts PLLC | Nashville, Tennessee | United States | |
| Arlington Research Center, Inc. | Arlington, Texas | United States | |
| Modern Research Associates PLLC | Dallas, Texas | United States | |
| Center for Clinical Studies 1 | Houston, Texas | United States | |
| Progressive Clinical Research | San Antonio, Texas | United States | |
| Texas Dermatology and Laser Specialists | San Antonio, Texas | United States | |
| Center for Clinical Studies | Webster, Texas | United States | |
| Kalo Clinical Research | West Valley City, Utah | United States | |
| Frontier Derm Partners CRO, LLC | Mill Creek, Washington | United States | |
| Consultora Integral de Salud SRL | Barrio Gral Paz Cba Capital | Argentina | |
| Instituto Medico De Alta Complejidad (IMAC) | Buenos Aires | Argentina | |
| Mindout Research | Buenos Aires | Argentina | |
| Instituto de Neumonologia y Dermatologia | Buenos Aires | Argentina | |
| Buenos Aires Skin | CABA | Argentina | |
| Investigaciones Medicas IMOBA SRL | CABA | Argentina | |
| CIPREC | CABA | Argentina | |
| Halitus Instituto Medico S.A. - Dermatologia y Estetica | Caba | Argentina | |
| Mautalen Salud e Investigacion | CABA | Argentina | |
| Hospital Italiano de Buenos Aires | CABA | Argentina | |
| Instituto De Especialidades De La Salud SRL | Rosario | Argentina | |
| MR Medicina Reumatologica | San Fernando | Argentina | |
| Instituto de Investigaciones Medicas Tucuman | San Miguel de Tucumán | Argentina | |
| Monash Medical Centre | Clayton | Australia | |
| Cornerstone Dermatology | Coorparoo | Australia | |
| Veracity Clinical Research | Greenslopes | Australia | |
| Premier Specialists | Kogarah | Australia | |
| The Alfred Hospital | Melbourne | Australia | |
| Royal Melbourne Hospital | Melbourne | Australia | |
| ISHI dermatology | Mitcham | Australia | |
| Westmead Hospital | Westmead | Australia | |
| LKH Feldkirch | Feldkirch | Austria | |
| Kepler Universitatsklinikum GmbH | Linz | Austria | |
| Universtitatsklinikum St Poelten | Sankt Pölten | Austria | |
| Allgemeines Krankenhaus der Stadt Wien | Vienna | Austria | |
| UZ Brussel | Brussels | Belgium | |
| AZ St. Lucas | Ghent | Belgium | |
| Ghent University Hospital | Ghent | Belgium | |
| Universitair Ziekenhuis Leuven | Leuven | Belgium | |
| Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman | Liège | Belgium | |
| Dermatologie Maldegem | Maldegem | Belgium | |
| Skincare Studio Inc Dermatology Clinical Trials | St. John's, Newfoundland and Labrador | Canada | |
| CCA Medical Research Corporation | Ajax, Ontario | Canada | |
| SimcoDerm Medical and Surgical Dermatology Centre | Barrie, Ontario | Canada | |
| Dermatrials Research | Hamilton, Ontario | Canada | |
| Lovegrove Dermatology | London, Ontario | Canada | |
| Lynderm Research Inc. | Markham, Ontario | Canada | |
| Alliance Clinical Trials | Waterloo, Ontario | Canada | |
| Innovaderm Research Inc. | Montreal, Quebec | Canada | |
| The Centre de recherche Saint-Louis | Québec, Quebec | Canada | |
| Aalborg Sygehus Syd | Aalborg | Denmark | |
| Aarhus University Hospital | Aarhus | Denmark | |
| Gentofte Hospital | Hellerup | Denmark | |
| Bispebjerg Hospital | København NV | Denmark | |
| Odense University Hospital | Odense | Denmark | |
| Sjællands University hospital | Roskilde | Denmark | |
| Klinikum Augsburg | Augsburg | Germany | |
| Fachklinik Bad Bentheim | Bad Bentheim | Germany | |
| ISA - Interdisciplinary Study Association GmbH | Berlin | Germany | |
| Universitatsklinikum Bonn | Bonn | Germany | |
| Studienzentrum an der Hase GbR | Bramsche | Germany | |
| Rosenpark Research GmbH | Darmstadt | Germany |
60 more sites not listed.