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A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis (ICONIC-PsA 1)

Last Updated   April 24, 2025

Want to learn how to participate in this trial?

77242113PSA3001

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
    phase 3
    3
  • Sites
    12 Sites
  • Status
    Recruiting

SUMMARY

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.

CONDITIONS

  • Arthritis, Psoriatic

ELIGIBILITY


Inclusion Criteria:

* Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) at screening
* Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tender joints at screening and at baseline (b) C-reactive protein (CRP) greater than or equal to (>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory
* Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
* Have active plaque psoriasis with at least one psoriatic plaque of >= 2 cm diameter or nail changes consistent with psoriasis
* A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention


Exclusion Criteria:

* Has previously received any biologic disease-modifying antirheumatic drugs (DMARDs) for PsA or psoriasis
* Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances
* Has known allergies, hypersensitivity, or intolerance to icotrokinra or its excipients
* Has other inflammatory diseases that might confound the evaluations of benefit of icotrokinra therapy, including but not limited to rheumatoid arthritis (RA), systemic lupus erythematosus, or lyme disease
* Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator's opinion, would have potential to interfere with efficacy assessments


Inclusion Criteria:

* Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) at screening
* Have active PsA as defined by: (a) At least 3 swollen j

More...

DETAILS

LOCATIONS

Locations in:
United States, Australia, China, Japan, Taiwan
Country (5) City or Province (12) Status
United States DeBary Omega Research Consultants
RECRUITING
Australia Parramatta BJC Health
RECRUITING
China Beijing Peking University Third Hospital
RECRUITING
China Chengdu Sichuan Provincial Peoples Hospital
RECRUITING
China Guiyang The Affiliated Hospital of Guizhou Medical University
RECRUITING
China Shanghai Huashan Hospital Fudan University
RECRUITING
China Taiyuan Shanxi Bethune Hospital
RECRUITING
China Wenzhou The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Japan Itabashi Ku Teikyo University Hospital
RECRUITING
Japan Oita Maeshima Rheumatology Clinic
RECRUITING
Japan Sasebo Sasebo Chuo Hospital
RECRUITING
Taiwan Hsin Chu National Taiwan University Hospital Hsin Chu Branch
RECRUITING
Show More
Geo Locations

28.88305, -81.30868

-33.81667, 151

39.9075, 116.39723

30.66667, 104.06667

26.58333, 106.71667

31.22222, 121.45806

37.86944, 112.56028

27.99942, 120.66682

35.74893, 139.71497

33.23333, 131.6

33.16832, 129.72501

24.8039455, 120.9646866

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50

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10

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5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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