Assessing JNJ-77242113 for treating moderate to severe plaque psoriasis
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 Psoriasis
This study is testing a new medication called JNJ-77242113 to see if it can help people with moderate to severe plaque psoriasis feel better compared to a placebo and an existing treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 675 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | ustekinumab |
| Locations | 116 sites (Birmingham, Alabama and 115 other locations) |
| Trial ID | NCT06934226 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of JNJ-77242113 compared to a placebo and ustekinumab in individuals with moderate to severe plaque psoriasis. Participants will be assessed based on their total body surface area affected by psoriasis and severity scores. The study aims to determine how well JNJ-77242113 performs in alleviating symptoms compared to existing treatments. It is a Phase 3 interventional trial, indicating a focus on confirming effectiveness and monitoring side effects.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with moderate to severe plaque psoriasis, with a significant body surface area affected.
Not a fit: Patients with nonplaque forms of psoriasis or those with drug-induced psoriasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from moderate to severe plaque psoriasis.
How similar studies have performed: Previous studies have shown promise in treating plaque psoriasis with similar biologic approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Birmingham, Alabama and 115 other locations
- Cahaba Research Inc — Birmingham, Alabama, United States (Recruiting)
- Integrative Skin Science and Research — Sacramento, California, United States (Recruiting)
- Southern California Dermatology — Santa Ana, California, United States (Recruiting)
- Driven Research LLC — Coral Gables, Florida, United States (Recruiting)
- Bioclinical Research Alliance Inc. — Miami, Florida, United States (Recruiting)
- Renstar Medical Research — Ocala, Florida, United States (Recruiting)
- Forcare Clinical Research Inc — Tampa, Florida, United States (Recruiting)
- Hamilton Research LLC — Alpharetta, Georgia, United States (Recruiting)
- Indiana Clinical Trial Center — Plainfield, Indiana, United States (Recruiting)
- Equity Medical — Bowling Green, Kentucky, United States (Recruiting)
- Metro Boston Clinical Partners — Brighton, Massachusetts, United States (Recruiting)
- The Derm Institute of West Michigan — Caledonia, Michigan, United States (Recruiting)
- Henry Ford Hospital — Detroit, Michigan, United States (Recruiting)
- Hamzavi Dermatology — Fort Gratiot, Michigan, United States (Recruiting)
- Somerset Skin Centre — Troy, Michigan, United States (Recruiting)
- Minnesota Clinical Study Center — New Brighton, Minnesota, United States (Recruiting)
- Cleaver Dermatology — Kirksville, Missouri, United States (Recruiting)
- MediSearch Clinical Trials — Saint Joseph, Missouri, United States (Recruiting)
- Sadick Research Group — New York, New York, United States (Recruiting)
- Wilmington Dermatology Center — Wilmington, North Carolina, United States (Recruiting)
- Optima Research — Boardman, Ohio, United States (Recruiting)
- Oregon Medical Research Center — Portland, Oregon, United States (Recruiting)
- Oregon Dermatology and Research Center — Portland, Oregon, United States (Recruiting)
- Clinical Research Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Health Concepts — Rapid City, South Dakota, United States (Recruiting)
- Advanced Research Experts PLLC — Nashville, Tennessee, United States (Recruiting)
- Arlington Research Center, Inc. — Arlington, Texas, United States (Recruiting)
- Modern Research Associates PLLC — Dallas, Texas, United States (Recruiting)
- Center for Clinical Studies — Houston, Texas, United States (Recruiting)
- Progressive Clinical Research — San Antonio, Texas, United States (Recruiting)
- Texas Dermatology and Laser Specialists — San Antonio, Texas, United States (Recruiting)
- Center for Clinical Studies — Webster, Texas, United States (Recruiting)
- Kalo Clinical Research — West Valley City, Utah, United States (Recruiting)
- Frontier Derm Partners CRO, LLC — Mill Creek, Washington, United States (Recruiting)
- Mindout Research — Buenos Aires, Argentina (Recruiting)
- Instituto de Neumonologia y Dermatologia — Buenos Aires, Argentina (Recruiting)
- Investigaciones Medicas IMOBA SRL — Caba, Argentina (Recruiting)
- Ciprec — Caba, Argentina (Recruiting)
- Halitus Instituto Medico S.A. - Dermatologia y Estetica — Caba, Argentina (Recruiting)
- Mautalen Salud e Investigacion — Caba, Argentina (Recruiting)
- Instituto De Especialidades De La Salud SRL — Rosario, Argentina (Recruiting)
- Instituto de Investigaciones Medicas Tucuman — Tucuman, Argentina (Recruiting)
- Cornerstone Dermatology — Coorparoo, Australia (Recruiting)
- Premier Specialists — Kogarah, Australia (Recruiting)
- The Alfred Hospital — Melbourne, Australia (Recruiting)
- Royal Melbourne Hospital — Melbourne, Australia (Recruiting)
- ISHI dermatology — Mitcham, Australia (Recruiting)
- AZ St. Lucas — Gent, Belgium (Recruiting)
- Ghent University Hospital — Ghent, Belgium (Recruiting)
- CCA Medical Research Corporation — Ajax, Ontario, Canada (Recruiting)
+66 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.