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JNJ-77242113 for Plaque Psoriasis

Phase 3

Waitlist Available

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

Must not have

Current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances

Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 24 through week 156

Awards & highlights

Pivotal Trial

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.

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.

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

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I am eligible for light therapy or medication for my plaque psoriasis.

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My body surface area is at least 10%.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe or worsening problems with my kidneys, liver, heart, blood vessels, lungs, stomach, hormones, nerves, blood, joints, mind, or metabolism.

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My psoriasis is not the plaque type but another form like guttate or pustular.

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My psoriasis was triggered or worsened by certain medications.

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I am not allergic to JNJ-77242113, deucravacitinib, or their ingredients.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 6Eligibility criteria met