What is icotrokinra studying for psoriatic arthritis?

Icotrokinra is being studied to see how it affects the signs and symptoms of active psoriatic arthritis in people who have or have not previously used biologic treatments. The trial aims to evaluate its impact on joint swelling, skin symptoms, and quality of life. Janssen Research & Development, LLC is sponsoring this research.

Who may be eligible for this psoriatic arthritis clinical trial?

Adults aged 18 years or older with active psoriatic arthritis despite prior treatments may be eligible. Both males and females can join, but women of childbearing potential must meet pregnancy test requirements. People with severe health problems or recent cancer history may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this psoriatic arthritis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should plan accordingly for their visits.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06807424

A Phase 3 Study Evaluating the Efficacy and Safety of Icotrokinra JNJ-77242113 in Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis

Led by Janssen Research & Development, LLC · Updated on 2026-06-05

750

Participants Needed

216

Research Sites

88 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of icotrokinra JNJ-77242113 compared to a placebo in people with active psoriatic arthritis PsA, including those who have previously used biologic treatments and those who have not. The study aims to assess how well icotrokinra reduces the signs and symptoms of PsA, a condition involving joint inflammation and skin psoriasis. This is a Phase 3, randomized, double-blind, placebo-controlled trial sponsored by Janssen Research Development, LLC. Participants will be randomly assigned to receive one of two doses of icotrokinra or a placebo. After 16 weeks, those on placebo will switch to one of the icotrokinra doses. Those who continue without discontinuing the treatment will have the option to join a long-term extension phase, continuing the same icotrokinra dose. The study involves careful monitoring of the participants response to the medication over time. Throughout the trial, participants will undergo assessments measuring improvements in joint swelling and tenderness, skin psoriasis severity, physical function, fatigue, and overall quality of life. These include American College of Rheumatology ACR responses, Psoriatic Area and Severity Index PASI scores, and health questionnaires. Safety and tolerance will also be closely monitored. The study is planned to last until October 2028, with regular visits and evaluations to track progress and side effects.

CONDITIONS

Brief Title

A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 years or older
Diagnosed with active psoriatic arthritis for at least 3 months and meeting CASPAR criteria
Active psoriatic arthritis with at least 3 swollen and 3 tender joints at screening and baseline
C-reactive protein (CRP) level of 0.1 mg/dL or higher at screening
Have at least one subset of psoriatic arthritis (e.g., distal interphalangeal joint involvement, polyarticular arthritis without rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis)
Active plaque psoriasis with at least one psoriatic plaque of 2 cm or larger or nail changes consistent with psoriasis
For women of childbearing potential: negative pregnancy tests at screening and before starting treatment

You will not qualify if you...

History or current severe, progressive, or uncontrolled kidney, liver, heart, blood vessel, lung, digestive, hormone, nerve, blood, rheumatic (other than psoriatic arthritis), mental health, urinary, or metabolic disorders
Current or past cancer diagnosis within 5 years before screening
Known allergies or intolerance to icotrokinra or its ingredients
Other inflammatory diseases that could affect study results, such as rheumatoid arthritis, lupus, or Lyme disease
Fibromyalgia or osteoarthritis symptoms that might interfere with study measurements according to the investigator's judgment

Research Team

Study Contact

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