Icotrokinra for Psoriatic Arthritis

(ICONIC-PsA 1 Trial)

Recruiting at 126 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

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.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

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.

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

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

Treatment Details

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.

Participant Groups

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+

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