Recruiting NCT06807424

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

Phase III Interventional Arthritis, Psoriatic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Icotrokinra, Placebo.
Who it may be relevant to: Registry conditions: Arthritis, Psoriatic. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Brazil, Bulgaria +19
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis

Overview

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.

Interventions

Drug Icotrokinra
Icotrokinra will be administered.
Drug Placebo
Placebo will be administered.

Primary outcome measures

Proportion of Participants who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16 [Time frame: Week 16]

Secondary outcome measures (12)

Proportion of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 16 Among Participants with Baseline Body Surface Area (BSA) Greater Than Equal to (>=) 3 Percent (%) and With Baseline IGA Score of >=2 [Time frame: Week 16]
Proportion of Participants Who Achieved PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2 [Time frame: Week 16]
Proportion of Participants Who Achieved PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2 [Time frame: Week 16]
Proportion of Participants with an Investigator Global Assessment (IGA) Psoriasis Score of 0 or 1 And >=2 Grade Improvement From Baseline at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2 [Time frame: Week 16]
Proportion of Participants who Achieved an ACR 50 Response at Week 16 [Time frame: Week 16]
Proportion of Participants who Achieved an ACR 70 Response at Week 16 [Time frame: Week 16]
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16 [Time frame: From baseline up to Week 16]
Changes From Baseline in 36 Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16 [Time frame: From baseline up to Week 16]
Proportion of Participants With Resolution of Enthesitis at Week 16 Among Those With Enthesitis at Baseline [Time frame: Week 16]
Change From Baseline in Enthesitis Score at Week 16 in Participants With Enthesitis at Baseline [Time frame: Baseline and Week 16]
Proportion of Participants With Resolution of Dactylitis at Week 16 Among Those With Dactylitis at Baseline [Time frame: Week 16]
Change From Baseline in Dactylitis Score at Week 16 in Participants With Dactylitis at Baseline [Time frame: From baseline up to Week 16]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment

Study locations

United States · 25 centers

AARA Clinical Research — Glendale
AARA Clinical Research 1 — Mesa
Arthritis and Rheumatism Associates ARA Jonesboro — Jonesboro
Clinical Research of West Florida — Clearwater
Omega Research Consultants — DeBary
Suncoast Clinical Research — New Port Richey
Integral Rheumatology And Immunology Specialists — Plantation
Clinical Research of West Florida 1 — Tampa
… and 17 more centers

China · 25 centers

Peking University Third Hospital — Beijing
Beijing Tong Ren Hospital Capital Medical University — Beijing
The First Bethune Hospital of Jilin University — Changchun
Xiangya Hospital Central South University — Changsha
West China Hospital Sichuan University — Chengdu
Sichuan Provincial Peoples Hospital — Chengdu
The First Affiliated Hospital of Chongqing Medical University — Chongqing
Dongguan People s Hospital — Dongguan
… and 17 more centers

Poland · 19 centers