JNJ-77242113 for Plaque Psoriasis

(ICONIC-ASCEND Trial)

Not currently recruiting at 183 trial locations

Overseen By Study Contact

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, Organ transplant, 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: 104 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new treatment, JNJ-77242113, for individuals with moderate to severe plaque psoriasis. Participants will receive either JNJ-77242113 (an experimental treatment), ustekinumab (a current psoriasis medication), or a placebo to compare the treatments' effectiveness. Individuals with plaque psoriasis covering at least 10% of their body and who require light therapy or medication might be suitable candidates. As a Phase 3 trial, this study is the final step before FDA approval, offering participants the opportunity to contribute to the development of a potentially groundbreaking treatment.

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

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, JNJ-77242113 (also known as Icotrokinra) showed no safety concerns for people with plaque psoriasis. Research indicates that skin improvement lasted for up to a year, with no new safety issues, suggesting the treatment is well-tolerated.

Ustekinumab, already approved by the FDA for treating plaque psoriasis, has a known safety record and is generally considered safe.

Overall, both JNJ-77242113 and Ustekinumab have demonstrated good safety results in studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about JNJ-77242113 for plaque psoriasis because it offers a new approach by targeting specific immune pathways differently compared to existing treatments. While most psoriasis treatments, like biologics such as ustekinumab, focus on inhibiting certain proteins involved in inflammation, JNJ-77242113 works by potentially modulating the body's immune response in a novel way. This could lead to more effective control of symptoms with possibly fewer side effects. The unique daily oral administration of JNJ-77242113 also provides a convenient alternative to the injections or infusions required for many current psoriasis medications.

What evidence suggests that this trial's treatments could be effective for plaque psoriasis?

Research has shown that JNJ-77242113, a pill, may help treat moderate-to-severe plaque psoriasis. In one study, 84.1% of patients achieved almost clear skin, based on a standard skin check. Another study found that JNJ-77242113 outperformed a placebo, which contains no active medicine. The drug blocks a protein called IL-23, which contributes to the inflammation causing psoriasis. In this trial, participants will receive JNJ-77242113 in one treatment arm, while another arm will receive Ustekinumab, an active comparator. These findings suggest that JNJ-77242113 could be an effective treatment option for people with this skin condition. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for people with moderate to severe plaque psoriasis, which means they have a lot of skin area affected and it's quite serious. They should be candidates for light therapy or systemic treatment and haven't started the study treatment before.

Inclusion Criteria

My psoriasis is severe, with a PASI score of 12 or more.

I have been diagnosed with plaque psoriasis, with or without psoriatic arthritis.

My body surface area is at least 10% affected.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JNJ-77242113, ustekinumab, or placebo according to their assigned arm. JNJ-77242113 is administered once daily from Week 0 through Week 104, with placebo or ustekinumab administered at specific intervals to maintain the blind.

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
• Ustekinumab

Trial Overview The trial tests JNJ-77242113 against a placebo and Ustekinumab to see which is better at treating plaque psoriasis. Participants will randomly receive either the new drug, its placebo, Ustekinumab, or its placebo.

How Is the Trial Designed?

Group I: Arm 1: JNJ 77242113 Experimental Treatment 2 Interventions

Participants will receive JNJ-77242113 once daily from Week 0 through Week 104. All participant will receive ustekinumab matching placebo at Week 0, 4 and 16 to maintain the blind.

Group II: Arm 3: Ustekinumab Active Control 3 Interventions

Participants will receive Ustekinumab at Week 0, Week 4, and Week 16 followed by JNJ-77242113 once daily from Week 28 through Week 104. Participants will receive both Ustekinumab and placebo for JNJ-77242113 to maintain the blind through Week 28.

Group III: Arm 2: Placebo Placebo Group 3 Interventions

Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for ustekinumab at Week 0, 4 and 16 and JNJ-77242113 from Week 16 through Week 104.

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

Citations

1. jnj.com jnj.com/media-center/press-releases/icotrokinra-results-show-75-of-adolescents-with-plaque-psoriasis-achieved-completely-clear-skin-and-demonstrate-favorable-safety-profile-in-a-once-daily-pill

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 ...

2. 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 ...

3. 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 ...

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

A Study of JNJ-77242113 for the Treatment of Moderate- ... The hypothesis of this study is that an oral tablet formulation of JNJ-77242113 will result in superior efficacy compared with placebo as determined by the ...

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

JNJ-77242113, a highly potent, selective peptide targeting ... JNJ-77242113 inhibited IL-23–induced interferon (IFN)γ production in NK cells, and in blood from healthy donors and psoriasis patients (IC50: ...

6. jnj.com jnj.com/innovativemedicine/uk/our-innovation/focus-areas/immunology/icotrokinra-plaque-psoriasis-trials

Icotrokinra shows superiority to deucravacitinib in the first ... Study on the Effectiveness and Safety of JNJ-77242113 for Treating Moderate to Severe Plaque Psoriasis in Adults. EudraCT number: 2023 ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT05223868

NCT05223868 | A Study of JNJ-77242113 in Participants ... 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.

9. 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 ...