255 Participants Needed

A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis

(FRONTIER 1 Trial)

Recruiting at 100 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Janssen Research & Development, LLC
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before starting. If you've used specific psoriasis treatments like IL-23R, IL-17, IL-12/23, or TNF-alpha therapies, you need to stop them at least 12 weeks or 5 half-lives before the trial. B cell-depleting agents must be stopped 26 weeks prior.

Who Is on the Research Team?

JR

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

Inclusion Criteria

You have a BSA greater than or equal to 10% at screening and baseline.
Participant has a total Psoriasis area and severity index (PASI) >=12 at screening and baseline
Participant has a total Investigator global assessment (IGA) >=3 at screening and baseline
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

≤ 4 weeks

Treatment

Participants receive JNJ-77242113 or placebo for 16 weeks to evaluate efficacy and safety in moderate-to-severe plaque psoriasis

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • JNJ-77242113
How Is the Trial Designed?
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

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