A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs. The long term extension period will provide additional long-term efficacy and safety information.

Official Title
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A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

Conditions
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Psoriatic Arthritis

Intervention / Treatment
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* Drug: Deucravacitinib
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening Meets the Classification Criteria for Psoriatic Arthritis at Screening Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at screening Active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at Screening and day 1 Participant has high sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading Must have completed the week 52 treatment for the optional open-label long-term extension period Exclusion Criteria: Nonplaque psoriasis at screening or day 1 Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease) Active fibromyalgia Received an approved or investigational biologic therapy for the treatment of PsA or PsO Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deucravacitinib<br> | Drug: Deucravacitinib<br>* Specified dose on specified days<br>* Other names: BMS-986165;|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR 20) response |  | At week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Disease Activity Score 28 with C-reactive protein (DAS28-CRP) score |  | At week 16 | 
| Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score |  | At week 16 | 
| Proportion of participants meeting Psoriatic Area and Severity Index (PASI) 75 response |  | At week 16 | 
| Change from baseline in the Short Form-36 Physical Component Survey (SF-36 PCS) score |  | At week 16 | 
| Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Leeds Enthesitis Index (LEI) |  | At week 16 | 
| Proportion of participants meeting achievement of Minimal Disease Activity (MDA) |  | At week 16 | 
| Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score |  | At week 16 | 
| Proportion of participants meeting dactylitis resolution at week 16 among the participants with dactylitis at baseline |  | At week 16 | 
| Change from baseline in PsA-modified Sharp-van der Heijde (SvdH) score |  | At week 16 | 
| Proportion of participants meeting ACR 20 response |  | Up to 16 weeks | 
| Proportion of participants meeting American College of Rheumatology improvement of 50% (ACR 50) response |  | Up to 16 weeks | 
| Proportion of participants meeting American College of Rheumatology improvement of 70% (ACR 70) response |  | Up to 16 weeks | 
| Change from baseline in HAQ-DI score |  | Up to 16 weeks | 
| Proportion of participants who achieve a clinically meaningful improvement (≥ 0.35 improvement from baseline) in HAQ-DI score among participants with a HAQ-DI score ≥ 0.35 at baseline |  | Up to 16 weeks | 
| Proportion of participants with achievement of PASI 75 response |  | Up to 16 weeks | 
| Proportion of participants with achievement of PASI 90 response |  | Up to 16 weeks | 
| Proportion of participants with achievement of PASI 100 response |  | Up to 16 weeks | 
| Change from baseline in the SF-36 PCS score |  | Up to 16 weeks | 
| Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by LEI |  | Up to 16 weeeks | 
| Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) |  | Up to 16 weeks | 
| Proportion of participants meeting achievement of MDA |  | Up to 16 weeks | 
| Change from baseline in SF-36 Mental Component Summary (MCS) score |  | Up to 16 weeks | 
| Change from baseline in FACIT-Fatigue score |  | Up to 16 weeks | 
| Proportion of participants meeting dactylitis resolution among the participants with dactylitis at baseline |  | Up to 16 weeks | 
| Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 score |  | Up to 16 weeks | 
| Change from baseline in Disease Activity Index for Psoriatic Arthritis Score (DAPSA) score |  | Up to 16 weeks | 
| Proportion of participants with achievement of DAPSA low disease activity response |  | Up to 16 weeks | 
| Proportion of participants with achievement of DAPSA disease remission |  | Up to 16 weeks | 
| Proportion of participants meeting achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 in participants with a baseline PGA-F score of ≥ 3 |  | Up to 16 weeks | 
| Change from baseline in DAS28-CRP score |  | Up to 16 weeks | 
| Proportion of participants with achievement of a DAS28-CRP low disease activity response |  | Up to 16 weeks | 
| Proportion of participants with achievement of a DAS28-CRP disease remission |  | Up to 16 weeks | 
| Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) |  | Up to 16 weeks | 
| Change from baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) score |  | Up to 16 weeks | 
| Proportion of participants achieving Psoriatic Arthritis Response Criteria (PsARC) |  | Up to 16 weeks | 
| Proportion of participants meeting achievement of improvement from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score among participants with spondylitis in addition to peripheral joint involvement as their presentation of PsA |  | Up to 16 weeks | 
| Proportion of participants meeting achievement of total PsA-modified SvdH score of ≤ 0 |  | At week 16 | 
| Proportion of participants meeting achievement of total PsA-modified SvdH score of ≤ 0.5 |  | At week 16 | 
| Proportion of participants meeting achievement of total PsA-modified SvdH score of ≤ smallest detectable change (SDC) |  | At week 16 | 
| Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of ≤ 0 |  | At week 16 | 
| Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of ≤ 0.5 |  | At week 16 | 
| Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of ≤ SDC |  | At week 16 | 
| Proportion of participants meeting achievement of PsA-modified SvdH joint space narrowing (JSN) score change of ≤ 0 |  | At week 16 | 
| Proportion of participants meeting achievement of PsA-modified SvdH JSN score change of ≤ 0.5 |  | At week 16 | 
| Proportion of participants meeting achievement of PsA-modified SvdH JSN score change of ≤ SDC |  | At week 16 | 
| Change in PsA-modified SvdH erosion score from baseline |  | At week 16 | 
| Change in PsA-modified SvdH JSN score |  | At week 16 | 
| Change from baseline in domain scales scores of SF-36 |  | Up to 16 weeks | 
| Change from baseline in PCS score of SF-36 |  | Up to 16 weeks | 
| Change from baseline in MCS score of SF-36 |  | Up to 16 weeks | 
| Change from baseline in the subcomponents of the Work Productivity and Activity Impairment (WPAI) questionnaire |  | Up to 16 weeks | 
| Change from baseline in the 5-level EuroQoL 5-dimension (EQ-5D) utility scores |  | Up to 16 weeks | 
| Change from baseline in the 5-level EQ-5D-5L utility score subcomponents |  | Up to 16 weeks | 
| Change from baseline in Patient-Reported Outcome Measures Information System (PROMIS) sleep disturbance score (short form) |  | Up to 16 weeks | 
| Incidence of adverse events (AEs) |  | Up to 156 weeks | 
| Incidence of serious adverse events (SAEs) |  | Up to 156 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biologic-Naive, BMS-986165, Deucravacitinib, Disease-modifying Anti-rheumatic Drugs, DMARDs, Joint Disease, Psoriatic Arthritis, PsA