JNJ-77242113 for Plaque Psoriasis

Recruiting at 136 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must not be taking: Beta blockers, Calcium channel blockers, Lithium

Disqualifiers: Nonplaque psoriasis, Severe organ disturbances, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

731 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if your psoriasis is drug-induced, you may not be eligible to participate.

Is JNJ-77242113 safe for treating plaque psoriasis?

Research on similar treatments, called JAK inhibitors, shows they generally have a safety profile similar to a placebo (a harmless pill used in studies for comparison), except for some specific doses of deucravacitinib. Tofacitinib, another JAK inhibitor, was noted for having a good safety profile. ^{1 2 3 4 5}

Research Team

Janssen Research & Development, LLC Clinicaltrial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for individuals with moderate to severe plaque psoriasis who have had the condition for at least 26 weeks and are candidates for phototherapy or systemic treatment. They must have a PASI score of 12 or more, an IGA of 3 or higher, and psoriasis affecting at least 10% of their body surface area.

Inclusion Criteria

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

Total psoriasis area and severity index (PASI) >=12 at screening and baseline

Total investigator global assessment (IGA) >=3 at screening and baseline

Exclusion Criteria

My psoriasis is not the plaque type.

I haven't had major surgery in the last 8 weeks and don't plan any during the study.

I do not have severe or worsening health issues in any part of my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JNJ-77242113, placebo, or deucravacitinib for the treatment of moderate to severe plaque psoriasis

24 weeks

Regular visits as per study protocol

Long-term Treatment

Participants continue receiving JNJ-77242113 for extended treatment

Week 24 through Week 156

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• JNJ-77242113

Trial Overview The study tests the effectiveness of JNJ-77242113 in treating plaque psoriasis compared to a placebo and another medication called deucravacitinib. Participants will be randomly assigned to receive either JNJ-77242113, its matching placebo, deucravacitinib, or its matching placebo.

Participant Groups

Group I: JNJ-77242113 Experimental Treatment 2 Interventions

Participants will receive JNJ-77242113 from Week 0 through Week 156 and deucravacitinib matching placebo from Week 0 through Week 24.

Group II: Deucravacitinib Active Control 3 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: Placebo Placebo Group 3 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.

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

Findings from Research

In a real-world study of 1756 patients with moderate-to-severe plaque-type psoriasis, secukinumab demonstrated high treatment retention rates of 88.0% after 1 year, 76.4% after 2 years, and 60.5% after 3 years, indicating its effectiveness in long-term management.

The safety profile of secukinumab remained consistent with previous findings, showing low rates of serious adverse events such as inflammatory bowel disease (0.3%) and candida infections (3.1%), suggesting it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab demonstrated sustained retention, effectiveness and safety in a real-world setting in patients with moderate-to-severe plaque psoriasis: long-term results from an interim analysis of the SERENA study. Augustin, M., Sator, PG., von Kiedrowski, R., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and safety of Janus kinase inhibitors in patients with psoriasis and psoriatic arthritis: a systematic review and meta-analysis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The efficacy and safety of tofacitinib, peficitinib, solcitinib, baricitinib, abrocitinib and deucravacitinib in plaque psoriasis - A network meta-analysis. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Relative efficacy and safety of Janus kinase inhibitors for the treatment of active psoriatic arthritis: a network meta-analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Secukinumab demonstrated sustained retention, effectiveness and safety in a real-world setting in patients with moderate-to-severe plaque psoriasis: long-term results from an interim analysis of the SERENA study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. [2021]