Icotrokinra for Psoriatic Arthritis

(ICONIC-PsA 2 Trial)

Recruiting at 140 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

Trial Summary

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.

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in biologic-experienced participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires