A Long-term Extension Study of JNJ-77242113 in Participants With Moderate-to-Severe Plaque Psoriasis

(FRONTIER 2 Trial)

Recruiting at 74 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

Must not be taking: Biologics, Experimental therapies

Disqualifiers: Hepatitis B, Hepatitis C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

227 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called JNJ-77242113 for people with moderate-to-severe plaque psoriasis. These patients often need better treatments. The drug aims to improve their skin by changing how their immune system works.

Will I have to stop taking my current medications?

The trial requires you to stop using topical treatments that could affect psoriasis, except for nonmedicated emollients and salicylic acid shampoos, before starting the study. The protocol does not specify about other medications, so it's best to discuss with the study team.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

Inclusion Criteria

Agree not to receive a live virus or live bacterial vaccination during the study, or within 4 weeks after the last administration of study intervention

Must have completed the Week 16 visit in Protocol 77242113PSO2001

In the opinion of the investigator, may benefit from inclusion in this long term extension (LTE) study

Exclusion Criteria

Has received any live virus or bacterial vaccination within 12 weeks before the first administration of study intervention

Currently has hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or has other clinically active liver disease, or tests positive for HBsAg or anti-HCV

Was permanently discontinued from study intervention in Protocol 77242113PSO2001 for any reason

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• JNJ-77242113

Participant Groups

Group I: Group 6: JNJ-77242113 Dose 3 QD Experimental Treatment 1 Intervention

Participants originally randomized to placebo in originating Study 77242113PSO2001 will receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study.

Group II: Group 5: JNJ-77242113 Dose 3 BID Experimental Treatment 1 Intervention

Participants originally randomized to JNJ-77242113 Dose 3 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 BID from Week 0 through Week 36 in this study.

Group III: Group 4: JNJ-77242113 Dose 1 Twice Daily (BID) Experimental Treatment 1 Intervention

Participants originally randomized to JNJ-77242113 Dose 1 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 BID from Week 0 through Week 36 in this study.

Group IV: Group 3: JNJ-77242113 Dose 3 QD Experimental Treatment 1 Intervention

Participants originally randomized to JNJ-77242113 Dose 3 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study.

Group V: Group 2: JNJ-77242113 Dose 2 QD Experimental Treatment 1 Intervention

Participants originally randomized to JNJ-77242113 Dose 2 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 2 QD from Week 0 through Week 36 in this study.

Group VI: Group 1: JNJ-77242113 Dose 1 Once Daily (QD) Experimental Treatment 1 Intervention

Participants originally randomized to JNJ-77242113 Dose 1 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 QD from Week 0 through Week 36 in this study.

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