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

Phase 3Active Not RecruitingNCT06878404

Janssen Research & Development, LLC552 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

552

Conditions

Arthritis, Psoriatic

Interventions

IcotrokinraDRUG

Icotrokinra will be administered.

PlaceboDRUG

Placebo will be administered.

Active reference comparatorDRUG

Active reference drug will be administered.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (155)

Outcomes

Primary Outcomes

Proportion of Participants who Achieve an American College of Rheumatology (ACR) ACR 20 Response at Week 16

The ACR 20 responders are participants with an improvement of greater than or equal to (\>=) 20 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).

Time frame: Week 16

Secondary Outcomes

Proportion of Participants Who Achieve 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 an IGA Score of >=2 at Baseline

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.

Time frame: Week 16

Proportion of Participants Who Achieve PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.

Data from ClinicalTrials.gov

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Arthritis and Rheumatism Associates ARA Jonesboro

Jonesboro, Arkansas, United States

Omega Research Consultants

DeBary, Florida, United States

Integral Rheumatology And Immunology Specialists

Plantation, Florida, United States

Clinical Research of West Florida

Tampa, Florida, United States

Willow Rheumatology and Wellness PLLC

Willowbrook, Illinois, United States

Joint and Muscle Research Institute

Charlotte, North Carolina, United States

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States

Arthritis and Rheumatology Research Institute

Allen, Texas, United States

Naiara Alvarez MD Integrative Rheumatology of South TX

Harlingen, Texas, United States

Cosultorios Reumatologógicos Pampa

Buenos Aires, Argentina

...and 145 more locations

Proportion of Participants Who Achieve PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100 response represents participants who achieved at least a 100 percent improvement from baseline in the PASI score.

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 an IGA Score of >=2 at Baseline

Proportion of participants with an IGA psoriasis score of 0 or 1 and \>=2 grade improvement from baseline at week 16 among participants with \>=3% BSA and an IGA score of \>=2 at baseline will be reported. The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling, each using a 5-point scale: using 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe) scale. The IGA score of psoriasis is based upon the average of induration, erythema, and scaling scores. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

Time frame: Week 16

Proportion of Participants who Achieve an ACR 50 Response at Week 16

The ACR 50 responders are participants with an improvement of \>= 50 % from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain VAS, patient's global assessment of disease activity VAS scale, physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).

Time frame: Week 16

Proportion of Participants who Achieve an ACR 70 Response at Week 16

The ACR 70 responders are participants with an improvement of \>= 70 % from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain VAS, patient's global assessment of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).

Time frame: Week 16

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16

The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score is computed as the sum of domain scores and divided by the number of domains answered. Total possible score range is 0-3 where 0 = least difficulty and 3 = extreme difficulty.