JNJ-77242113 for Plaque Psoriasis

(ICONIC-TOTAL Trial)

Not currently recruiting at 126 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

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: 156 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called JNJ-77242113 to evaluate its effectiveness for people with plaque psoriasis, particularly in challenging areas like the scalp, genitals, or hands and feet. Researchers aim to determine if this treatment can improve the condition more effectively than current options. The trial includes two groups: one receives the new treatment from the start, while the other begins with a placebo (a harmless pill) before switching to JNJ-77242113. It suits individuals who have had plaque psoriasis for at least six months and have not found success with other topical treatments like creams or ointments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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

Previous studies have shown promising safety results for JNJ-77242113. Research indicates that people with moderate-to-severe plaque psoriasis have tolerated this treatment well. One study found no major safety concerns after a year of use, suggesting that the treatment is manageable for patients. While every treatment can have side effects, the data so far suggests that JNJ-77242113 does not present major safety issues. ^{1 2 3 4 5}

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

Researchers are excited about JNJ-77242113 for plaque psoriasis because it offers a new approach compared to standard treatments like biologics, topical treatments, and systemic medications. Most treatments work by targeting specific proteins or pathways involved in inflammation, but JNJ-77242113 works differently, offering a novel mechanism of action that targets distinct pathways involved in the immune response. Additionally, while many existing treatments need to be administered frequently or have slow onset times, JNJ-77242113 has the potential for sustained effectiveness over a longer period, which could mean fewer doses and more convenience for patients.

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

Research has shown that JNJ-77242113 effectively treats plaque psoriasis. In earlier studies, patients taking JNJ-77242113 had clearer skin compared to those on a placebo. Notably, 79% of patients on the highest dose experienced significant improvement in their psoriasis symptoms. This trial will include a treatment arm where participants receive JNJ-77242113 from Week 0 through Week 156. Another arm will start with a placebo from Week 0 through Week 16, followed by JNJ-77242113 from Week 16 through Week 156. This treatment targets a protein called interleukin-23, which is involved in inflammation, helping to reduce the plaques. Overall, JNJ-77242113 has shown promising results in improving the skin condition of people with moderate-to-severe plaque psoriasis. ^{2 3 6 7 8}

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 people who've had plaque psoriasis, including on the scalp, genitals, or palms and soles of the feet, for at least half a year. They should need systemic treatment or phototherapy and have tried at least one topical therapy without success. Participants must not have non-plaque psoriasis types or skin conditions that could interfere with the study.

Inclusion Criteria

I have plaque psoriasis on parts of my body other than my scalp, genitals, or palms/soles.

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

I have been diagnosed with plaque psoriasis for at least 6 months.

Exclusion Criteria

My psoriasis started or got worse after taking certain medications.

I do not have severe or worsening problems with my kidneys, liver, heart, blood vessels, lungs, stomach, hormones, nerves, blood, joints, mind, or metabolism.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JNJ-77242113 or placebo for 16 weeks, followed by JNJ-77242113 for up to 156 weeks

156 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 trial tests JNJ-77242113's effectiveness against placebo in treating plaque psoriasis in sensitive areas. It aims to see if this new medication can improve symptoms better than a non-active treatment (placebo).

How Is the Trial Designed?

Group I: JNJ-77242113 Experimental Treatment 1 Intervention

Participants will receive JNJ-77242113 from Week 0 through Week 156.

Group II: Placebo Placebo Group 2 Interventions

Participants will receive placebo from Week 0 through Week 16 and thereafter will receive 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+

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. clinicaltrials.gov clinicaltrials.gov/study/NCT05223868

A Study of JNJ-77242113 in Participants With Moderate-to- ... Th purpose of the study is to evaluate the dose response of JNJ-77242113 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.

7. 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.

8. nature.com nature.com/articles/s41598-024-67371-5

JNJ-77242113, a highly potent, selective peptide targeting ... Descriptive statistics were used to describe demographic and safety data. Data availability. The data sharing policy of Janssen ...