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

(FRONTIER 1 Trial)

Recruiting at 100 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

Must not be taking: IL-23R agents, IL-17 agents

Disqualifiers: Nonplaque psoriasis, Drug-induced psoriasis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

255 Participants Needed

Trial Summary

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.

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.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

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

Timeline

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

Treatment Details

Interventions

• JNJ-77242113

Participant Groups

Group I: Group 5: JNJ-77242113 Dose 3 BID and Placebo Experimental Treatment 2 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 Placebo Experimental Treatment 2 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 Placebo Experimental Treatment 2 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 Placebo Experimental Treatment 2 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 Placebo Experimental Treatment 2 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: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires