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JNJ-77242113 for Plaque Psoriasis

Phase 3
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Candidate for phototherapy or systemic treatment for plaque psoriasis
Total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 24 through week 156
Awards & highlights

Study Summary

This trial aims to determine how well JNJ-77242113 works in people with moderate to severe plaque psoriasis, compared to a placebo and deucravacitinib.

Who is the study for?
This trial is for people with moderate to severe plaque psoriasis who need phototherapy or systemic treatment. They should have had psoriasis, possibly with arthritis, for at least 6 months and it must cover more than 10% of their body surface area.Check my eligibility
What is being tested?
The study tests the effectiveness of JNJ-77242113 against a placebo and another drug called Deucravacitinib in treating plaque psoriasis. Participants will be randomly assigned to receive one of these treatments.See study design
What are the potential side effects?
Potential side effects may include typical reactions seen with immune-modulating drugs such as infections, liver enzyme changes, blood count variations, fatigue, headache, skin irritation at injection sites and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am eligible for light therapy or medication for my plaque psoriasis.
Select...
My body surface area is at least 10%.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 24 through week 156
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 24 through week 156 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2-Grade Improvement From Baseline to Week 16
Secondary outcome measures
Change From Baseline in Body Surface Area (BSA) at Week 16
Change from Baseline in PASI Total Score at Week 16
JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving DLQI Score of 0 or 1 at Weeks 16 and 24
+31 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: JNJ-77242113Experimental Treatment3 Interventions
Participants will receive JNJ-77242113 from Week 0 through Week 156 and deucravacitinib matching placebo from Week 0 through Week 24.
Group II: DeucravacitinibActive Control4 Interventions
Participants will receive deucravacitinib from Week 0 through Week 24 and matching placebo for JNJ-77242113 from Week 0 through Week 24 and JNJ-77242113 from Week 24 through Week 156.
Group III: PlaceboPlacebo Group3 Interventions
Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for deucravacitinib from Week 0 through Week 24 and JNJ-77242113 from Week 16 through Week 156.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-77242113
2022
Completed Phase 2
~640

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
976 Previous Clinical Trials
6,383,942 Total Patients Enrolled
Janssen Research & Development, LLC ClinicaltrialStudy DirectorJanssen Research & Development, LLC
1 Previous Clinical Trials
675 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being recruited for participation in this clinical study?

"To conduct this research, a total of 750 eligible individuals who meet the specified inclusion criteria are required. Participants may enroll in this clinical study from multiple locations including Tokyo Medical University Hospital in Tokyo, Florida and Dawes Fretzin Clinical Research Group, LLC in Indianapolis, Ohio."

Answered by AI

Are participants currently being enrolled for this study?

"Indeed, according to the details provided on clinicaltrials.gov, this research study is actively seeking eligible candidates. The initial posting of the clinical trial was made on February 5th, 2024 and it underwent its most recent update on January 31st, 2024. A total of 750 participants are being sought from a pool of potential enrollees across 51 different locations."

Answered by AI

What are the potential risks associated with JNJ-77242113 when administered to individuals?

"JNJ-77242113 is rated as a 3 on the safety scale by our team at Power, given that this trial is in Phase 3 and has evidence supporting its effectiveness, along with multiple rounds of data confirming its safety."

Answered by AI

Can you confirm if there is a significant number of medical facilities conducting this clinical study within the United States?

"This clinical trial is being conducted at Tokyo Medical University Hospital in Tokyo, Florida, Dawes Fretzin Clinical Research Group, LLC in Indianapolis, Ohio, and Forcare Clinical Research, Inc. in Tampa, South dakota. Additionally, there are 51 other locations where the study is taking place."

Answered by AI

Who else is applying?

What site did they apply to?
Medical Dermatology Specialists
What portion of applicants met pre-screening criteria?
Met criteria
~500 spots leftby Mar 2025