684 Participants Needed

JNJ-77242113 for Plaque Psoriasis

(ICONIC-LEAD Trial)

Recruiting at 203 trial locations
No Placebo GroupAll 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 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 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.12345

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?

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.
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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.
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Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment2 Interventions
Group II: JNJ-77242113Experimental Treatment1 Intervention

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

Published Research Related to This Trial

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.
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]

Citations

Efficacy and safety of Janus kinase inhibitors in patients with psoriasis and psoriatic arthritis: a systematic review and meta-analysis. [2023]
The efficacy and safety of tofacitinib, peficitinib, solcitinib, baricitinib, abrocitinib and deucravacitinib in plaque psoriasis - A network meta-analysis. [2022]
Relative efficacy and safety of Janus kinase inhibitors for the treatment of active psoriatic arthritis: a network meta-analysis. [2023]
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]
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]
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