What side effects are associated with this type of intervention?

Common treatments for plaque psoriasis, such as TNF-alpha inhibitors (e.g., infliximab, adalimumab), IL-17 inhibitors (e.g., secukinumab, ixekizumab), IL-12/23 inhibitors (e.g., ustekinumab), and IL-23 inhibitors (e.g., guselkumab), have various side effects. TNF-alpha inhibitors can increase the risk of infections, including tuberculosis, and may be associated with cardiovascular events. IL-17 inhibitors are linked to an increased risk of inflammatory bowel disease and infections. IL-12/23 inhibitors may cause serious infections and have been associated with cardiovascular events. IL-23 inhibitors generally have a favorable safety profile but can also lead to infections. Patients should discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

Several monoclonal antibodies have been approved by the FDA for the treatment of moderate-to-severe plaque psoriasis. These include ustekinumab, which targets interleukin-12 and interleukin-23 (IL-12/23), and secukinumab and ixekizumab, which target interleukin-17A (IL-17A). Brodalumab, another approved treatment, targets the interleukin-17 receptor (IL-17R). These drugs work by inhibiting specific inflammatory pathways involved in the pathogenesis of plaque psoriasis, similar to the mechanism likely employed by JNJ-77242113.

What other types of research exist?

Promising novel alternatives to JNJ-77242113 for plaque psoriasis include: 1) Secukinumab, an anti-IL-17A monoclonal antibody, which has shown efficacy and safety in global trials including Taiwanese patients. 2) Risankizumab, an anti-IL-23p19 biologic, which has demonstrated significant efficacy in phase III trials compared to ustekinumab and placebo. 3) Ixekizumab, another IL-17A antagonist, which has been effective in treating moderate-to-severe psoriasis, including nail psoriasis. 4) Brodalumab, targeting the IL-17 receptor, which has shown long-term efficacy and safety in phase III trials. These alternatives offer targeted approaches to managing plaque psoriasis by inhibiting specific inflammatory pathways.

← Back to Search

Monoclonal Antibodies

JNJ-77242113 for Plaque Psoriasis (ICONIC-LEAD Trial)

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Candidate for phototherapy or systemic treatment for plaque psoriasis

Total body surface area (BSA) greater than or equal to (>=) 10 percent (%) at screening and baseline

Must not have

Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)

Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24 to week 52

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, common side effects from treatments like JNJ-77242113 may include skin reactions at the injection site, gastrointestinal issues, headaches, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

My body surface area is at least 10%.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

My psoriasis started or got worse after taking certain medications.

Select...

I haven't had major surgery in the last 8 weeks or have any planned during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24 to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24 to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16

Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>= )2-Grade Improvement From Baseline to Week 16

Secondary study objectives

Change From Baseline in CDLQI at Week 16

Change From Baseline in PSSD Sign Score to Week 16

Change From Baseline in PSSD Symptom Score to Week 16

+31 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment2 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-77242113Experimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

JNJ-77242113

2022

Completed Phase 2

~640

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Plaque Psoriasis often target specific inflammatory pathways to reduce symptoms and prevent disease progression. Monoclonal antibodies, such as those targeting the IL-12/23 and IL-17 pathways (e.g., ustekinumab, secukinumab), work by inhibiting key cytokines involved in the inflammatory process. TNF-alpha inhibitors (e.g., etanercept, adalimumab) block the action of TNF-alpha, a cytokine that promotes inflammation. JAK inhibitors (e.g., tofacitinib) interfere with the JAK/STAT signaling pathway, which is crucial for the activation of immune cells. These treatments are significant for Plaque Psoriasis patients as they offer targeted approaches to control inflammation, reduce plaque formation, and improve overall skin health, leading to better disease management and quality of life.

A Scoping Review on Use of Drugs Targeting the JAK/STAT Pathway in Psoriasis.Leukemic phase of follicular lymphoma after treatment with etanercept in a patient with psoriasis.