JNJ-77242113 for Plaque Psoriasis

(ICONIC-LEAD Trial)

Not currently recruiting at 235 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called JNJ-77242113, an experimental therapy, to evaluate its effectiveness for individuals with moderate to severe plaque psoriasis, a skin condition that causes itchy, scaly patches. Participants will initially receive either the new treatment or a placebo, a substance with no active drug, and later switch to the actual treatment. This trial suits those who have had plaque psoriasis for at least six months and require more than topical treatments. As a Phase 3 trial, it represents the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new treatment.

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 there any evidence suggesting that JNJ-77242113 is likely to be safe for humans?

Research has shown that JNJ-77242113 has undergone safety testing in earlier studies. In one study, participants used the treatment for up to a year without major safety issues. The results indicated good tolerance over time. Another study confirmed that the safety findings aligned with earlier reports, revealing no new concerns about its use. This suggests that JNJ-77242113 is generally safe for individuals with moderate to severe plaque psoriasis. However, discussing possible side effects with a doctor before joining any clinical trial is always important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for plaque psoriasis?

Unlike the standard treatments for plaque psoriasis, which often involve topical agents, phototherapy, and systemic medications like methotrexate and biologics targeting TNF-alpha, IL-17, or IL-23, JNJ-77242113 is unique because it offers a novel approach. Researchers are excited about this treatment because it targets a new mechanism, potentially providing relief for patients who haven't responded well to existing therapies. Another distinctive feature is its extended treatment duration, as it is designed for long-term use, which could lead to sustained improvements over time. This innovation provides hope for more personalized and effective management of plaque psoriasis.

What evidence suggests that JNJ-77242113 might be an effective treatment for plaque psoriasis?

Research has shown that JNJ-77242113, which participants in this trial may receive, offers promising results for treating moderate-to-severe plaque psoriasis. One study found that many patients had much clearer skin after 52 weeks. Higher doses of JNJ-77242113 led to even better results, with 79% of patients in the highest dose group seeing improvements. Compared to a placebo, another treatment arm in this trial, JNJ-77242113 consistently reduced psoriasis symptoms more effectively. Overall, the evidence supports the potential of JNJ-77242113 to effectively manage plaque psoriasis. ^{3 6 7 8 9}

Who Is on the Research Team?

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.

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 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?

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+

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

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.

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]

Citations

1. jnj.com jnj.com/media-center/press-releases/new-data-shows-jnj-2113-the-first-and-only-investigational-targeted-oral-peptide-maintained-skin-clearance-in-moderate-to-severe-plaque-psoriasis-through-one-year

New data shows JNJ-2113, the first and only ... In FRONTIER 2, JNJ-2113 maintained high rates of skin clearance through 52 weeks in adults with moderate-to-severe plaque PsO.

2. jaad.org jaad.org/article/S0190-9622(24)03152-9/fulltext

FRONTIER-2: A phase 2b, long-term extension, dose- ... Higher response rates were observed among patients receiving higher doses of JNJ-77242113, with 79% of those in the highest dose group (100 mg ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38324484/

An Oral Interleukin-23-Receptor Antagonist Peptide for ... ... JNJ-77242113 showed greater efficacy than placebo in patients with moderate-to-severe plaque psoriasis. (Funded by Janssen Research and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05357755

A Study of JNJ-77242113 for the Treatment of Moderate- ... The purpose of the study is to evaluate the efficacy of an oral tablet formulation of JNJ-77242113 compared with placebo in participants with moderate-to-severe ...

5. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2308713

An Oral Interleukin-23–Receptor Antagonist Peptide for ... ... JNJ-77242113 showed greater efficacy than placebo in patients with moderate-to-severe plaque psoriasis. (Funded by Janssen Research and ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39549848/

FRONTIER-2: A phase 2b, long-term extension, dose- ... Rates of skin clearance with JNJ-77242113 were durable to 1 year and no safety signals were identified.

7. jnj.com jnj.com/innovativemedicine/emea/newsroom/immunology/new-data-shows-jnj-2113-the-first-and-only-investigational-targeted-oral-peptide-maintained-skin-clearance-in-moderate-to-severe-plaque-psoriasis-through-one-year

New data shows JNJ-2113, the first and only ... JNJ-2113 long-term extension FRONTIER 2 study demonstrated sustained efficacy from Week 16 to Week 52 and safety results consistent with previously reported ...

8. jaad.org jaad.org/article/S0190-9622(24)03152-9/pdf

FRONTIER-2: A phase 2b, long-term extension, dose- ... Results from the FRONTIER-2 study indicate that JNJ-77242113, a targeted oral peptide blocking the interleukin-23 receptor, provides durable ...

9. prnewswire.com prnewswire.com/news-releases/icotrokinra-results-show-75-of-adolescents-with-plaque-psoriasis-achieved-completely-clear-skin-and-demonstrate-favorable-safety-profile-in-a-once-daily-pill-302425136.html

Icotrokinra results show 75% of adolescents with plaque ... In the study, 84.1% of adolescent patients treated with once daily icotrokinra achieved an Investigator's Global Assessment (IGA)b score of 0/1 ...