A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis (ICONIC-PsA 2)

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 3

Conditions: Arthritis, Psoriatic

Treatments: Drug: Placebo; Drug: Icotrokinra

Study type: Interventional

Funder types: Industry

Identifiers

NCT06807424

77242113PSA3002 (Other Identifier)

2024-517284-23-00 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have been previously treated with 1 biologic agent for psoriatic arthritis (PsA) or psoriasis and the reason for discontinuation must be documented
• 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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750 participants in 3 patient groups, including a placebo group

Group I: Icotrokinra Dose 1

Experimental group

Description:

Participants will receive icotrokinra Dose 1. Participants who have not discontinued will be eligible to enter a long term extension (LTE) and will continue to receive icotrokinra Dose 1.

Treatment:

Drug: Icotrokinra

Group II: Icotrokinra Dose 2

Experimental group

Description:

Participants will receive icotrokinra Dose 2. Participants who have not discontinued will be eligible to enter a LTE and will continue to receive icotrokinra Dose 2.

Treatment:

Drug: Icotrokinra

Group III: Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra Dose 1 or Dose 2 at Week 16. Participants who have not discontinued will be eligible to enter a LTE and will continue to receive icotrokinra Dose 1 or Dose 2.

Treatment:

Drug: Icotrokinra

Drug: Placebo