Icotrokinra for Psoriatic Arthritis
(ICONIC-PsA 1 Trial)

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Janssen Research & Development, LLC

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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

Eligibility Criteria

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.

+2 more

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.

+2 more

Trial Timeline

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

Participant Groups

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.

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Group II: Icotrokinra Dose 2Experimental Treatment1 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 1Experimental Treatment1 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 ComparatorActive Control2 Interventions

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

Group IV: Group III: PlaceboPlacebo Group2 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.