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Monoclonal Antibodies

A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis (FRONTIER 1 Trial)

Phase 2

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 weeks

Summary

This trial is testing a new drug called JNJ-77242113 to help people with severe psoriasis. It targets the immune system to reduce skin issues. The study focuses on those who do not respond well to standard treatments.

Eligible Conditions

Plaque Psoriasis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16

Secondary study objectives

Serum albumin, bovine

Change from Baseline in PASI Total Score at Week 16

Change from Baseline in PSSD Signs Score at Week 16

+12 more

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 5: JNJ-77242113 Dose 3 BID and PlaceboExperimental Treatment2 Interventions

Participants will receive JNJ-77242113 Dose 3 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Group II: Group 4: JNJ-77242113 Dose 1 Twice Daily (BID) and PlaceboExperimental Treatment2 Interventions

Participants will receive JNJ-77242113 Dose 1 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Group III: Group 3: JNJ-77242113 Dose 3 QD and PlaceboExperimental Treatment2 Interventions

Participants will receive JNJ-77242113 Dose 3 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Group IV: Group 2: JNJ-77242113 Dose 2 QD and PlaceboExperimental Treatment2 Interventions

Participants will receive JNJ-77242113 Dose 2 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Group V: Group 1: JNJ-77242113 Dose 1 Once Daily (QD) and PlaceboExperimental Treatment2 Interventions

Participants will receive JNJ-77242113 Dose 1 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Group VI: Group 6: PlaceboPlacebo Group1 Intervention

Participants will receive placebo BID from Week 0 through Week 16.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

JNJ-77242113

2022