JNJ-77242113 for Plaque Psoriasis

(ICONIC-LEAD Trial)

Recruiting at 202 trial locations

Age: Any Age

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

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

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

684 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called JNJ-77242113 to see if it helps people with moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches. The study aims to find out if this new treatment can improve symptoms for those who have not responded well to other treatments.

Do I need to stop my current medications to join the trial?

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). However, some specific JAK inhibitors like deucravacitinib at certain doses had more side effects, while others like tofacitinib were found to be safer. ^{1 2 3 4 5}

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for adolescents and adults with moderate to severe plaque psoriasis, who have had the condition for at least 6 months. They should need phototherapy or systemic treatment and have a significant area of their body affected. Women able to bear children must test negative for pregnancy.

Inclusion Criteria

Your skin has a lot of psoriasis, with a score of 12 or more on a scale that measures its severity.

Your overall skin condition is rated as moderate or worse by the study doctor at the beginning of the trial.

If you are a woman who could become pregnant, you need to have a negative pregnancy test before starting the study.

Exclusion Criteria

You are allergic to JNJ-77242113 or any of the substances it contains.

My psoriasis is not the plaque type but another form like guttate or pustular.

My psoriasis started or got worse after taking certain medications.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive JNJ-77242113 or placebo from Week 0 to Week 16

16 weeks

Re-randomization and Continued Treatment

Adult participants who respond are re-randomized to continue JNJ-77242113 or switch to placebo, with retreatment upon loss of response. Adolescents continue JNJ-77242113.

36 weeks

Long-term Treatment

All participants receive JNJ-77242113 from Week 52 to Week 156

104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• JNJ-77242113

Trial Overview The study is testing JNJ-77242113's effectiveness against placebo in participants with plaque psoriasis. It aims to see if this new medication can improve skin conditions compared to no active treatment.

Participant Groups

Group I: Placebo Experimental Treatment 2 Interventions

Adolescent and adult participants will receive JNJ-77242113 matching placebo from Week 0 to Week 16. Participants will cross-over to receive JNJ-77242113 from Week 16 through Week 156.

Group II: JNJ-77242113 Experimental Treatment 1 Intervention

Adolescent and adult participants will receive JNJ-77242113 from Week 0 through Week 156. At Week 24, adult participants who are psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieve an IGA score of 0 or 1 and have \>=2-grade improvement from baseline) will be re-randomized either to continue JNJ-77242113 or to placebo (and will be retreated with JNJ-77242113 upon loss of \>=50% of their Week 24 PASI improvement). Adult participants identified as both PASI 75 and IGA 0 or 1 score non-responders will continue to receive JNJ-77242113 through Week 52. From Week 52 to Week 156, all adult participants will receive JNJ-77242113. Adolescents will not participate in re-randomization regardless of their PASI score or IGA score at Week 24. Adolescents will continue to receive JNJ-77242113 from Week 0 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]