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 Treatment

Phase 3

Active, not recruiting

• Conditions: Psoriatic Arthritis
• Interventions: Drug: Deucravacitinib; Drug: Apremilast; Other: Placebo

• Registration Number: NCT04908189
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA who are naïve to biologic disease modifying antirheumatic drugs or had previously received TNFα inhibitor treatment.The long term extension period will provide additional long-term safety and efficacy information.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-05-28
• Study First Posted: 2021-06-01
• Study Start: 2021-07-15
• Primary Completion: 2024-02-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Study Completion: 2026-11-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 729

Inclusion Criteria

• Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at Screening
• Meets the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria 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
• Must have completed the week 52 treatment for the optional open-label long-term extension period

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Placebo	Deucravacitinib	-
Deucravacitinib	Deucravacitinib	-
Apremilast	Apremilast	-

Primary Outcome Measures

Name	Time	Method
Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20)	At week 16

Secondary Outcome Measures

Name	Time	Method
Change from baseline Health Assessment Questionnaire - Disability Index (HAQ-DI)	At week 16
Proportion of participants meeting ACR 20 response	Up to 16 weeks
Change from baseline in Disease Activity Index for Psoriatic Arthritis Score (DAPSA) score	Up to 16 weeks
Proportion of participants achieving Psoriatic Arthritis Response Criteria (PsARC)	Up to 16 weeks
Change from baseline in domain scales scores of SF-36	Up to 16 weeks
Change from baseline Disease Activity Score 28 with C-Reactive Protein (DAS28-CRP)	At week 16
Change from baseline 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 American College of Rheumatology improvement of 70% (ACR 70) response	Up to 16 weeks
Proportion of participants meeting PASI 90 response	Up to 16 weeks
Proportion of participants meeting PASI 100 response	Up to 16 weeks
Change from baseline in the SF-36 PCS score	Up to 16 weeks
Proportion of participants meeting Psoriatic Area and Severity Index (PASI) 75 response	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 among the participants with dactylitis at baseline	Up to 16 weeks
Proportion of participants meeting achievement of MDA	Up to 16 weeks
Proportion of participants meeting achievement of Minimal Disease Activity (MDA)	At week 16
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 meeting enthesitis resolution among participants with enthesitis at baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)	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 enthesitis resolution among participants with enthesitis at baseline by LEI	Up to 16 weeks
Proportion of participants with achievement of DAPSA disease remission	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
Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)	Up to 16 weeks
Incidence of Serious Adverse Events (SAEs)	Up to week 156
Proportion of participants meeting PASI 75 response	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
Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 score	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 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 EQ-5D utility score subcomponents	Up to 16 weeks
Incidence of Adverse Events (AEs)	Up to week 156
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
Change from baseline in PCS score of SF-36	Up to 16 weeks
Change from baseline in the 5-level EuroQoL 5-dimension (EQ-5D-5L) utility scores	Up to 16 weeks
Change from baseline in Patient- Reported Outcome Measures Information System (PROMIS) sleep disturbance score (short form)	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 a DAS28-CRP disease remission	Up to 16 weeks
Change from baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) score	Up to 16 weeks

Trial Locations

Locations (147)

Local Institution - 0200; 🇦🇷 Buenos Aires, Argentina

Local Institution - 0018; 🇦🇺 Paramatta, New South Wales, Australia

Local Institution - 0002; 🇦🇺 Camberwell, Victoria, Australia

Local Institution - 0149; 🇺🇸 Mountain Brook, Alabama, United States

First OC Dermatology-Dermatology; 🇺🇸 Fountain Valley, California, United States

Local Institution - 0212; 🇺🇸 Sacramento, California, United States

Local Institution - 0188; 🇺🇸 Whittier, California, United States

Bay Area Arthritis and Osteoporosis; 🇺🇸 Brandon, Florida, United States

Local Institution - 0192; 🇺🇸 Skokie, Illinois, United States

Local Institution - 0203; 🇺🇸 Hopkinsville, Kentucky, United States

Local Institution - 0195; 🇺🇸 Baton Rouge, Louisiana, United States

Local Institution - 0169; 🇺🇸 Cumberland, Maryland, United States

Local Institution - 0034; 🇺🇸 Okemos, Michigan, United States

Local Institution - 0133; 🇺🇸 Eagan, Minnesota, United States

Local Institution - 0109; 🇺🇸 Hattiesburg, Mississippi, United States

Local Institution - 0108; 🇺🇸 New York, New York, United States

Local Institution - 0186; 🇺🇸 Rochester, New York, United States

Local Institution - 0196; 🇺🇸 Charlotte, North Carolina, United States

Local Institution - 0180; 🇺🇸 Cleveland, Ohio, United States

Local Institution - 0189; 🇺🇸 Oklahoma City, Oklahoma, United States

Local Institution - 0147; 🇺🇸 Portland, Oregon, United States

Local Institution - 0016; 🇺🇸 Duncansville, Pennsylvania, United States

Local Institution - 0182; 🇺🇸 Summerville, South Carolina, United States

Local Institution - 0167; 🇺🇸 Lubbock, Texas, United States

Local Institution - 0070; 🇺🇸 Mesquite, Texas, United States

Local Institution - 0184; 🇺🇸 Plano, Texas, United States

Local Institution - 0187; 🇺🇸 Seattle, Washington, United States

University Of Washington; 🇺🇸 Seattle, Washington, United States

Local Institution - 0190; 🇺🇸 Franklin, Wisconsin, United States

Local Institution - 0175; 🇺🇸 Milwaukee, Wisconsin, United States

Local Institution - 0048; 🇦🇷 La Plata, Buenos Aires, Argentina

Local Institution - 0038; 🇦🇷 San Isidro, Buenos Aires, Argentina

Local Institution - 0039; 🇦🇷 Caba, Distrito Federal, Argentina

Local Institution - 0171; 🇦🇷 San Miguel de Tucumán, Tucuman, Argentina

Local Institution - 0037; 🇦🇷 Buenos Aires, Argentina

Local Institution - 0168; 🇦🇷 Cordoba, Argentina

Local Institution - 0003; 🇦🇺 Botany, New South Wales, Australia

Local Institution - 0004; 🇦🇺 Maroochydore, Queensland, Australia

Local Institution - 0099; 🇦🇺 Woodville, South Australia, Australia

Local Institution - 0017; 🇦🇺 Geelong, Victoria, Australia

Local Institution - 0078; 🇧🇪 Brussels, Belgium

Local Institution - 0058; 🇧🇪 Gent, Belgium

Local Institution - 0104; 🇧🇪 Leuven, Belgium

Local Institution - 0061; 🇧🇪 Liège, Belgium

Local Institution - 0111; 🇨🇦 Vancouver, British Columbia, Canada

Local Institution - 0006; 🇨🇦 Hamilton, Ontario, Canada

Local Institution - 0030; 🇨🇦 Markham, Ontario, Canada

Local Institution - 0036; 🇨🇦 Toronto, Ontario, Canada

Local Institution - 0001; 🇨🇦 Quebec, Canada

Local Institution - 0126; 🇨🇳 Bengbu, Anhui, China

Local Institution - 0152; 🇨🇳 Beijing, Beijing, China

Local Institution - 0146; 🇨🇳 Beijing, Beijing, China

Local Institution - 0153; 🇨🇳 Guangzhou, Guangdong, China

Local Institution - 0135; 🇨🇳 Guangzhou, Guangdong, China

Local Institution - 0206; 🇨🇳 Shenzhen, Guangdong, China

Local Institution - 0127; 🇨🇳 Zhengzhou, Henan, China

Local Institution - 0170; 🇨🇳 Changsha, Hunan, China

Local Institution - 0161; 🇨🇳 Changsha, Hunan, China

Local Institution - 0125; 🇨🇳 Changzhou, Jiangsu, China

Local Institution - 0138; 🇨🇳 Nanjing, Jiangsu, China

Local Institution - 0139; 🇨🇳 Nantong, Jiangsu, China

Local Institution - 0163; 🇨🇳 Wuxi, Jiangsu, China

Local Institution - 0148; 🇨🇳 Jiujiang, Jiangxi, China

Local Institution - 0131; 🇨🇳 Nanchang, Jiangxi, China

Local Institution - 0156; 🇨🇳 Nanchang, Jiangxi, China

Local Institution - 0140; 🇨🇳 Pingxiang, Jiangxi, China

Local Institution - 0191; 🇨🇳 Shenyang, Liaoning, China

Local Institution - 0158; 🇨🇳 Baotou, Neimeng, China

Local Institution - 0157; 🇨🇳 Hohhot, Neimeng, China

Local Institution - 0154; 🇨🇳 Xi'An, Shan3xi, China

Local Institution - 0207; 🇨🇳 Shanghai, Shanghai, China

Local Institution - 0164; 🇨🇳 Chengdu, Sichuan, China

Local Institution - 0117; 🇨🇳 Urumqi, Xinjiang, China

Local Institution - 0134; 🇨🇳 Kunming, Yunnan, China

Local Institution - 0129; 🇨🇳 Wenzhou, Zhejiang, China

Local Institution - 0072; 🇨🇴 Barranquilla, Atlántico, Colombia

Local Institution - 0015; 🇨🇴 Bogotá, Colombia

Local Institution - 0020; 🇨🇴 Cali, Colombia

Local Institution - 0022; 🇨🇴 Chía, Colombia

Local Institution - 0019; 🇨🇴 Medellin, Colombia

Local Institution - 0010; 🇨🇿 Brno, Czechia

Local Institution - 0009; 🇨🇿 Ostrava, Czechia

Local Institution - 0035; 🇨🇿 Ostrava, Czechia

Local Institution - 0011; 🇨🇿 Praha 2, Czechia

Local Institution - 0023; 🇨🇿 Uherske Hradiste, Czechia

Local Institution - 0176; 🇩🇪 Ratingen, Nordrhein-Westfalen, Germany

Local Institution - 0100; 🇩🇪 Düsseldorf, Germany

Local Institution - 0199; 🇩🇪 Erlangen, Germany

Local Institution - 0046; 🇩🇪 Hamburg, Germany

Local Institution - 0101; 🇩🇪 Köln, Germany

Local Institution - 0075; 🇩🇪 Magdeburg, Germany

Local Institution - 0201; 🇩🇪 Minden, Germany

Local Institution - 0074; 🇩🇪 Tübingen, Germany

Local Institution - 0025; 🇭🇺 Veszprem, Veszprém City, Hungary

Local Institution - 0197; 🇭🇺 Budapest, Hungary

Local Institution - 0066; 🇭🇺 Debrecen, Hungary

Local Institution - 0028; 🇭🇺 Gyula, Hungary

Local Institution - 0027; 🇭🇺 Kistarcsa, Hungary

Local Institution - 0024; 🇭🇺 Szarvas, Hungary

Azienda Ospedaliera Universitaria Careggi-Reumatologia; 🇮🇹 Firenze, Italy

AOR San Carlo di Potenza-UOC Reumatologia; 🇮🇹 Potenza, Italy

Local Institution - 0097; 🇮🇹 Roma, Italy

Local Institution - 0106; 🇯🇵 Nagoya-shi, Aichi, Japan

Local Institution - 0202; 🇯🇵 Nagoya, Aichi, Japan

Local Institution - 0151; 🇯🇵 Sapporo, Hokkaido, Japan

Local Institution - 0179; 🇯🇵 Tsu, MIE, Japan

Local Institution - 0123; 🇯🇵 Kawachinagano, Osaka, Japan

Local Institution - 0205; 🇯🇵 Bunkyō, Tokyo, Japan

Local Institution - 0121; 🇯🇵 Chuo-ku, Tokyo, Japan

Local Institution - 0067; 🇯🇵 Itabashi-ku, Tokyo, Japan

Local Institution - 0178; 🇯🇵 Meguro-ku, Tokyo, Japan

Local Institution - 0122; 🇯🇵 Minato-ku, Tokyo, Japan

Local Institution - 0174; 🇯🇵 Mitaka, Tokyo, Japan

Local Institution - 0065; 🇯🇵 Shinjuku-ku, Tokyo, Japan

Local Institution - 0155; 🇯🇵 Fukuoka, Japan

Local Institution - 0166; 🇯🇵 Osaka, Japan

Local Institution - 0204; 🇯🇵 Osaka, Japan

Local Institution - 0198; 🇲🇽 Mexico City, Distrito Federal, Mexico

Local Institution - 0052; 🇲🇽 Leon, Guanajuato, Mexico

Local Institution - 0051; 🇲🇽 Guadalajara, Jalisco, Mexico

Local Institution - 0057; 🇲🇽 Zapopan, Jalisco, Mexico

Local Institution - 0056; 🇲🇽 Merida, Yucatan, Mexico

Local Institution - 0053; 🇲🇽 Chihuahua, Mexico

Local Institution - 0082; 🇵🇱 Bydgoszcz, Kujawsko-pomorskie, Poland

Local Institution - 0177; 🇵🇱 Warszawa, Mazowieckie, Poland

Local Institution - 0079; 🇵🇱 Gdansk, Pomorskie, Poland

Local Institution - 0080; 🇵🇱 Elblag, Poland

Local Institution - 0081; 🇵🇱 Torun, Poland

Local Institution - 0112; 🇵🇱 Wrocław, Poland

Local Institution - 0208; 🇷🇺 Saint Petersburg, Sankt-Peterburg, Russian Federation

Local Institution; 🇷🇺 Moscow, Russian Federation

Local Institution - 0145; 🇷🇺 Saint Petersburg, Russian Federation

Local Institution - 0014; 🇪🇸 Barcelona, Spain

Local Institution - 0012; 🇪🇸 Madrid, Spain

Local Institution - 0045; 🇪🇸 Santander, Spain

Local Institution - 0013; 🇪🇸 València, Spain

Local Institution - 0090; 🇨🇳 Taichung City, Taiwan

Local Institution - 0089; 🇨🇳 Taichung, Taiwan

Local Institution - 0088; 🇨🇳 Taichung, Taiwan

Local Institution - 0091; 🇨🇳 Taipei, Taiwan

Local Institution - 0087; 🇨🇳 Taipei, Taiwan

Local Institution - 0185; 🇬🇧 London, England, United Kingdom

Local Institution - 0060; 🇬🇧 Bradford, United Kingdom

Local Institution - 0064; 🇬🇧 Hull, United Kingdom

Local Institution - 0077; 🇬🇧 Liverpool, United Kingdom

Local Institution - 0062; 🇬🇧 London, United Kingdom

Local Institution - 0105; 🇬🇧 Manchester, United Kingdom