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Monoclonal Antibodies

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) >=10% 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 see how well JNJ-77242113 works for people with moderate to severe plaque psoriasis when compared to a placebo and deucravacitinib.

Who is the study for?

This trial is for individuals with moderate to severe plaque psoriasis who have had the condition for at least 26 weeks and are candidates for phototherapy or systemic treatment. They must have a PASI score of 12 or more, an IGA of 3 or higher, and psoriasis affecting at least 10% of their body surface area.Check my eligibility

What is being tested?

The study tests the effectiveness of JNJ-77242113 in treating plaque psoriasis compared to a placebo and another medication called deucravacitinib. Participants will be randomly assigned to receive either JNJ-77242113, its matching placebo, deucravacitinib, or its matching placebo.See study design

What are the potential side effects?

Potential side effects may include typical drug reactions such as nausea, headache, possible skin irritation at the application site if topical, fatigue, and any specific risks associated with immune-modulating treatments like increased infection risk.

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...

At least 10% of my body is affected by my condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 24 through week 156

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 at Week 16

Secondary outcome measures

Change From Baseline in Body Surface Area (BSA) at Week 16

Change from Baseline in PASI Score at Week 16

JNJ-77242113 and Deucravacitinib Group: : Percentage of Participants Achieving an IGA Score of 0 or 1 and >=2 Grade Improvement From Baseline at Weeks 16 and 24

+31 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: JNJ-77242113Experimental Treatment2 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 Control3 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

977 Previous Clinical Trials

6,383,974 Total Patients Enrolled

Janssen Research & Development, LLC ClinicaltrialStudy DirectorJanssen Research & Development, LLC

1 Previous Clinical Trials

750 Total Patients Enrolled

Frequently Asked Questions

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

Has the medication JNJ-77242113 received approval from the FDA?

"Based on the fact that this trial is in Phase 3 and has accumulated multiple rounds of safety data along with some evidence of efficacy, our team at Power rates the safety of JNJ-77242113 as a 3."

Answered by AI

Are there any ongoing efforts to enroll participants in this medical study at the moment?

"As per the details provided on clinicaltrials.gov, this research trial is presently seeking participants. It was first listed on March 9th, 2024 and underwent its most recent revision on April 23rd, 2024."

Answered by AI

At how many sites is this particular research study currently being conducted?

"At the moment, 98 sites are actively enrolling participants for this research. These establishments are strategically located in Miami, Encino, and Bay City alongside several other locations. Opting for a nearby facility is crucial to reduce travel commitments if you choose to take part."

Answered by AI

What is the upper limit on the number of individuals enrolled in this clinical trial?

"A total of 675 eligible participants meeting the defined criteria are required for enrollment in this research. Interested individuals may join from various sites, such as Bioclinical Research Alliance Inc. situated in Miami, Florida, and T Joseph Raoof Md Inc. located in Encino, California."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)

2024. "A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06220604.

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