A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis
Janssen Research & Development, LLC · NCT06807424
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 750
- US sites recruiting
- 21
- Study start
- January 9, 2025
- Record last updated
- September 25, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The purpose of this study is to evaluate the efficacy of icotrokinra (JNJ-77242113) compared to placebo in biologic-experienced and biologic-naive participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
Being studied: Icotrokinra; Placebo
Conditions: Arthritis, Psoriatic
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Have active psoriatic arthritis (PsA) despite current or previous use of greater than or equal to (>=) 1 of the following: a. Non-biologic disease-modifying antirheumatic drug (DMARD) therapy; b. Apremilast therapy; c. Biologic-agent (limited to only 1)
- Have a diagnosis of 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) >= 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 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
- Currently has a malignancy or has a history of malignancy within 5 years prior to screening
- 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
Recruiting US locations
AARA Clinical Research
Glendale, AZ 85306
AARA Clinical Research 1
Mesa, AZ 85210
Arthritis and Rheumatism Associates ARA Jonesboro
Jonesboro, AR 72401
Clinical Research of West Florida
Clearwater, FL 33765
Omega Research Consultants
DeBary, FL 32713
Suncoast Clinical Research
New Port Richey, FL 34652
Integral Rheumatology And Immunology Specialists
Plantation, FL 33324
Clinical Research of West Florida 1
Tampa, FL 33606
Klein And Associates M D P A
Hagerstown, MD 21740
Albuquerque Rehabilitation and Rheumatology
Albuquerque, NM 87102
Joint and Muscle Research Institute
Charlotte, NC 28204
Rheumatology Associates of Oklahoma
Oklahoma City, OK 73116
Altoona Center For Clinical Research
Duncansville, PA 16635
Clinical Research Philadelphia
Philadelphia, PA 19114
UT Southwestern
Dallas, TX 75390
Arthritis and Rheumatology Research Institute
Frisco, TX 75035
AARA Clinical Research Lone Star Arthritis and Rheumatology
Irving, TX 75039
DM Clinical Research
Tomball, TX 77375
Velocity Clinical Research
Waco, TX 76710
Seattle Rheumatology
Seattle, WA 98104
Center of Rheumatic Diseases
Glendale, WI 53217
Study contacts (from the official record)
- Study Contact · 844-434-4210 · Participate-In-This-Study1@its.jnj.com
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