Icotrokinra for Psoriatic Arthritis

(ICONIC-PsA 1 Trial)

Recruiting at 189 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must not be taking: Biologic DMARDs

Disqualifiers: Severe renal, hepatic, cardiac, 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

540 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new treatment called icotrokinra to determine if it reduces symptoms of psoriatic arthritis (PsA), a condition causing joint pain and swelling, compared to a placebo (a harmless pill with no active drug). Participants will receive one of two doses of icotrokinra, an active reference drug, or a placebo, and will eventually switch to icotrokinra. Individuals who have had PsA for at least three months, experience joint pain and swelling, and have active plaque psoriasis (skin patches) might be suitable for this study. As a Phase 3 trial, this study is the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new 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. It's best to discuss this with the trial team or your doctor.

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

Research has shown that icotrokinra has been safe in previous studies. For instance, in trials for scalp and genital psoriasis, many patients experienced improvements without major safety concerns. Specifically, 72% of patients with scalp psoriasis and 85% with genital psoriasis showed significant skin improvement while using icotrokinra, accompanied by a good safety record.

Moreover, long-term studies suggest that icotrokinra is generally well-tolerated, with most people not experiencing serious side effects. Although icotrokinra remains under investigation, these findings indicate it has been safe for many participants in past studies. Consulting a doctor is always advisable to fully understand the safety of any treatment. ^{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 NSAIDs, DMARDs, and biologics targeting specific immune pathways, Icotrokinra offers a novel approach by directly modulating the immune response through a unique mechanism. Icotrokinra is a new active ingredient that targets specific cytokines involved in inflammation, potentially providing more targeted relief with fewer side effects. Researchers are excited because it could offer a more precise treatment option that improves symptoms faster and more effectively than current therapies.

What evidence suggests that this trial's treatments could be effective for psoriatic arthritis?

Studies have shown that icotrokinra works well for conditions like psoriatic arthritis. Earlier research demonstrated that icotrokinra improved skin symptoms in people with psoriasis, a condition related to psoriatic arthritis. Specifically, over 70% of teenagers with plaque psoriasis experienced noticeable skin improvement. Icotrokinra also outperformed a placebo in treating moderate-to-severe plaque psoriasis. In this trial, participants will receive either icotrokinra at different doses or a placebo. These findings suggest that icotrokinra might also help reduce symptoms for people with psoriatic arthritis. ^{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 individuals with active Psoriatic Arthritis (PsA) who have not used biologic DMARDs before. Participants must have at least 3 swollen and tender joints, a certain level of C-reactive protein, and either skin plaques or nail changes from psoriasis. Women of childbearing age need negative pregnancy tests to join.

Inclusion Criteria

I have one type of psoriatic arthritis without rheumatoid nodules.

I have been diagnosed with psoriatic arthritis for at least 3 months.

I have PsA with at least 3 swollen and 3 tender joints and a CRP level of >= 0.1 mg/dL.

Exclusion Criteria

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

I have taken biologic DMARDs for PsA or psoriasis.

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

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 to assess reduction in signs and symptoms of PsA

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Extension (LTE)

Participants may opt into continuation of treatment with icotrokinra long-term

What Are the Treatments Tested in This Trial?

Interventions

• Icotrokinra

Trial Overview The study is testing the effectiveness of Icotrokinra in reducing symptoms of PsA compared to a placebo. An 'active reference comparator' means there's also a known treatment being tested alongside for comparison purposes.

How Is the Trial Designed?

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

Participants will receive icotrokinra dose 2. Participants who continue into a LTE 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 continue into a long term extension (LTE) will continue to receive icotrokinra dose 1.

Group III: Group IV: Active Reference Comparator Active Control 2 Interventions

Participants will receive active reference drug. Participants who continue into a LTE will cross-over to receive icotrokinra dose 1 or dose 2.

Group IV: 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. Participants who continue into the LTE 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 ...