Icotrokinra for Psoriatic Arthritis

(ICONIC-PsA 2 Trial)

Recruiting at 253 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must be taking: Biologics

Disqualifiers: Severe organ disease, Malignancy, 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: 16 weeks

750 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called icotrokinra to determine if it reduces symptoms of psoriatic arthritis (PsA), a condition causing joint pain and swelling. Participants will receive either icotrokinra or a placebo (a dummy treatment), with those on placebo eventually switching to icotrokinra. The trial is open to individuals with active PsA, characterized by swollen and tender joints, who have tried at least one biologic treatment. The aim is to assess icotrokinra's effectiveness in reducing PsA signs and symptoms compared to a placebo. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new PsA treatment.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that icotrokinra is likely to be safe for humans?

Research has shown that icotrokinra is generally safe. In earlier studies, patients with scalp and genital psoriasis tolerated icotrokinra well. More than 70% of these patients experienced significant skin improvement without serious side effects. This suggests the treatment might also be safe for people with psoriatic arthritis. However, while these results are encouraging, icotrokinra is not yet fully proven for psoriatic arthritis. Participants should consider these findings when deciding to join the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for psoriatic arthritis?

Unlike the standard treatments for psoriatic arthritis, which often include TNF inhibitors and methotrexate, Icotrokinra is unique because it targets a different pathway in the immune system. This drug is designed to specifically inhibit interleukin-17 (IL-17), a protein that plays a key role in causing inflammation and joint damage in psoriatic arthritis. Researchers are excited about Icotrokinra because it could offer a new option for patients who do not respond well to current therapies, potentially reducing symptoms more effectively or with fewer side effects. Additionally, the possibility of different dosing options might provide more flexibility in managing the disease.

What evidence suggests that icotrokinra might be an effective treatment for psoriatic arthritis?

Research has shown that icotrokinra yields promising results for treating various types of psoriasis. In earlier studies, 72% of patients with scalp psoriasis and 85% with genital psoriasis experienced significant improvement. Icotrokinra also outperformed a placebo in trials for moderate-to-severe plaque psoriasis, resulting in higher response rates. In this trial, participants will receive either icotrokinra Dose 1, icotrokinra Dose 2, or a placebo. These findings suggest that icotrokinra might help reduce symptoms of psoriatic arthritis, given its success in similar conditions. While these results are encouraging, it's important to remember that outcomes can vary from person to person. ^{1 2 4 6 7}

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 have active psoriatic arthritis and have tried biologics before without success. Participants should be experiencing symptoms of PsA despite previous treatments.

Inclusion Criteria

I have one type of psoriatic arthritis without rheumatoid nodules.

I am a woman who can have children and have tested negative for pregnancy.

I was treated with a biologic for PsA or psoriasis and stopped for a specific reason.

Exclusion Criteria

I have or had cancer in the last 5 years.

I have severe ongoing health issues not related to my cancer.

Has known allergies, hypersensitivity, or intolerance to icotrokinra or its excipients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive icotrokinra or placebo for 16 weeks, with a crossover to icotrokinra at Week 16 for placebo group

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Extension

Participants who have not discontinued will be eligible to enter a long-term extension and continue to receive icotrokinra

What Are the Treatments Tested in This Trial?

Interventions

• Icotrokinra

Trial Overview The study tests the effectiveness of a new medication called Icotrokinra against a placebo in reducing the signs and symptoms of active psoriatic arthritis in patients who've used biologic therapies before.

How Is the Trial Designed?

Group I: Group II: Icotrokinra Dose 2 Experimental Treatment 1 Intervention

Participants will receive icotrokinra Dose 2. Participants who have not discontinued will be eligible to enter a LTE and will continue to receive icotrokinra Dose 2.

Group II: Group I: Icotrokinra Dose 1 Experimental Treatment 1 Intervention

Participants will receive icotrokinra Dose 1. Participants who have not discontinued will be eligible to enter a long term extension (LTE) and will continue to receive icotrokinra Dose 1.

Group III: Group III: Placebo Placebo Group 2 Interventions

Participants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra Dose 1 or Dose 2 at Week 16. Participants who have not discontinued will be eligible to enter a LTE and will continue to receive icotrokinra Dose 1 or Dose 2.

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-long-term-results-affirm-promise-of-targeted-oral-peptide-with-high-rates-of-durable-skin-clearance-and-favorable-safety-profile-in-difficult-to-treat-scalp-and-genital-psoriasis

Icotrokinra long-term results affirm promise of targeted oral ... In areas of high impact, 72% of patients with scalp psoriasis and 85% with genital psoriasis treated with icotrokinra achieved site-specific ...

2. prnewswire.com prnewswire.com/news-releases/icotrokinra-long-term-results-affirm-promise-of-targeted-oral-peptide-with-high-rates-of-durable-skin-clearance-and-favorable-safety-profile-in-difficult-to-treat-scalp-and-genital-psoriasis-302593288.html

Icotrokinra long-term results affirm promise of targeted oral ... In areas of high impact, 72% of patients with scalp psoriasis and 85% with genital psoriasis treated with icotrokinra achieved site-specific ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06807424

NCT06807424 | A Study to Evaluate the Efficacy and ... The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in biologic-experienced participants with active psoriatic ...

4. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)01576-4/fulltext?rss=yes

Once-daily oral icotrokinra versus placebo and ... Icotrokinra showed superior clinical response rates versus placebo and deucravacitinib in phase 3 moderate-to-severe plaque psoriasis trials, ...

5. healio.com healio.com/news/rheumatology/20251107/icotrokinra-superior-to-placebo-for-improving-skin-symptoms-in-adolescent-psoriasis

Icotrokinra bests placebo in adolescent plaque psoriasis Novel interleukin-23 inhibitor icotrokinra improved on placebo in adolescent psoriasis. Icotrokinra yielded more than 70% PASI response at 16 ...

6. isrctn.com isrctn.com/ISRCTN16757143

ISRCTN16757143: A study of the efficacy and safety ... Based on scientific theory, taking icotrokinra may improve active psoriatic arthritis. However, this cannot be guaranteed because icotrokinra is still under ...

7. psoriasis-hub.com psoriasis-hub.com/medical-information/iconic-lead-phase-iii-trial-week-24-results-icotrokinra-in-adults-and-adolescents-with-moderate-to-severe-plaque-psoriasis

ICONIC-LEAD phase III trial Week 24 results: Icotrokinra in ... At W16, the co-primary endpoints were met: 65% of ICO-treated vs 8% of placebo-treated patients achieved IGA 0/1, and 50% vs 4% achieved PASI 90 ...