跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT04908202
NCT04908202进行中（未招募）3 期

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

Bristol-Myers Squibb180 个研究点 分布在 4 个国家目标入组 650 人开始时间: 2021年7月13日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
进行中（未招募）
发起方
入组人数
650
试验地点
180
主要终点
Percentage of Participants With ACR 20 Response at Week 16
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Deucravacitinib

Experimental

干预措施: Deucravacitinib (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Other)

结局指标

主要结局

Percentage of Participants With ACR 20 Response at Week 16

时间窗: Week 16

The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method.

次要结局

  • Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16(Baseline and Week 16)
  • Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 16(Baseline and Week 16)
  • Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response at Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline(Week 16)
  • Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score at Week 16(Baseline and Week 16)
  • Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16(Week 16)
  • Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16(Week 16)
  • Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16(Baseline and Week 16)
  • Percentage of Participants Meeting Dactylitis Resolution at Week 16(Week 16)
  • Change From Baseline in PsA-modified Sharp-van Der Heijde (SvdH) Score at Week 16(Baseline and Week 16)
  • Percentage of Participants With ACR 20 Response up to Week 16(Week 2, 4, 8, 12, and 16)
  • Percentage of Participants With ACR 50 Response up to Week 16(Week 2, 4, 8, 12, and 16)
  • Percentage of Participants With ACR 70 Response up to Week 16(Week 2, 4, 8, 12, and 16)
  • Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16(Baseline and Week 2, 4, 8, 12, and 16)
  • Percentage of Participants Who Achieve a Clinically Meaningful Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Among Participants With a HAQ-DI Score ≥0.35 at Baseline(Baseline and Week 2, 4, 8, 12, and 16)
  • Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline(Week 4, 8, 12 and 16)
  • Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 90 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline(Week 4, 8, 12 and 16)
  • Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 100 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline(Week 4, 8, 12 and 16)
  • Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score up to Week 16(Baseline and Week 4, 12 and 16)
  • Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) up to Week 16(Week 4, 8, 12 and 16)
  • Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) up to Week 16(Week 4, 8, 12 and 16)
  • Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) up to Week 16(Week 4, 8, 12, and 16)
  • Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score up to Week 16(Baseline and Week 4, 12 and 16)
  • Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score up to Week 16(Baseline and Week 2, 4, 8, 12 and 16)
  • Percentage of Participants Meeting Dactylitis Resolution up to Week 16(Week 4, 8, 12 and 16)
  • Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score up to Week 16(Baseline and Week 2, 4, 8, 12 and 16)
  • Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score up to Week 16(Baseline and Week 2, 4, 8, 12 and 16)
  • Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response up to Week 16(Baseline and Week 2, 4, 8, 12 and 16)
  • Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission up to Week 16(Baseline and Week 2, 4, 8, 12 and 16)
  • Percentage of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 up to Week 16(Week 2, 4, 8, 12 and 16)
  • Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) up to Week 16(Baseline and Week 2, 4, 8, 12 and 16)
  • Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Low Disease Activity Response up to Week 16(Week 2, 4, 8, 12 and 16)
  • Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Disease Remission up to Week 16(Week 2, 4, 8, 12 and 16)
  • Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) up to Week 16(Baseline and Week 4, 12 and 16)
  • Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) up to Week 16(Baseline and Week 4, 8, 12 and 16)
  • Percentage of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) up to Week 16(Week 2, 4, 8, 12 and 16)
  • Percentage of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score up to Week 16(Week 2, 4, 8, 12 and 16)
  • Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= 0 at Week 16(Week 16)
  • Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= 0.5 at Week 16(Week 16)
  • Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= Smallest Detectable Change (SDC) at Week 16(Week 16)
  • Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= 0 at Week 16(Week 16)
  • Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= 0.5 at Week 16(Week 16)
  • Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= SDC at Week 16(Week 16)
  • Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= 0 at Week 16(Week 16)
  • Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= 0.5 at Week 16(Week 16)
  • Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= SDC at Week 16(Week 16)
  • Change From Baseline in PsA-modified SvdH Erosion Scores Response at Week 16(Baseline and Week 16)
  • Change From Baseline in PsA-modified SvdH JSN Scores Response at Week 16(Baseline and Week 16)
  • Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary Score up to Week 16(Baseline and Week 4, 12 and 16)
  • Change From Baseline in the 36-item Short Form (SF-36) Role Activity Subcomponent Summary Score up to Week 16(Baseline and Week 4, 12 and 16)
  • Change From Baseline in the 36-item Short Form (SF-36) Bodily Pain Subcomponent Summary Score up to Week 16(Baseline and Week 4, 12 and 16)
  • Change From Baseline in the 36-item Short Form (SF-36) General Health Perceptions Subcomponent Summary Score up to Week 16(Baseline and Week 4, 12 and 16)
  • Change From Baseline in the 36-item Short Form (SF-36) Vitality Subcomponent Score up to Week 16(Baseline and Week 4, 12 and 16)
  • Change From Baseline in the 36-item Short Form (SF-36) Social Subcomponent Score up to Week 16(Baseline and Week 4, 12 and 16)
  • Change From Baseline in the 36-item Short Form (SF-36) Mental Health Subcomponent Score up to Week 16(Baseline and Week 4, 12 and 16)
  • Change From Baseline in the 36-item Short Form (SF-36) Emotional Problems Subcomponent Score up to Week 16(Baseline and Week 4, 12 and 16)
  • Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Subcomponents Score at Week 16(Baseline and week 16)
  • Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16(Baseline and week 4 and 16)
  • Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS) Sleep Disturbance up to Week 16(Baseline and week 4, 12, and 16)

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (180)

Loading locations...

相似试验

进行中（未招募）
3 期
A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus
NCT05617677Bristol-Myers Squibb516
进行中（未招募）
3 期
A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus ErythematosusSystemic Lupus Erythematosus
NCT05620407Bristol-Myers Squibb513
进行中（未招募）
3 期
A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's SyndromeSjögren's Syndrome
NCT05946941Bristol-Myers Squibb774
进行中（未招募）
3 期
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 or Had Previously Received TNFα Inhibitor TreatmentPsoriatic Arthritis
NCT04908189Bristol-Myers Squibb729
已完成
4 期
Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp PsoriasisPsoriasis
NCT05478499Bristol-Myers Squibb154
A Study to Determine the Efficacy and Safety of... | 临床试验