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

Phase 3

Active, not recruiting

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

• Registration Number: NCT04908202
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

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: 2021-07-13
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-31
• Primary Completion: 2024-09-03
• Study Completion: 2027-05-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Deucravacitinib	Deucravacitinib	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of serious adverse events (SAEs)	Up to 156 weeks
Proportion of participants with achievement of a DAS28-CRP disease remission	Up to 16 weeks
Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Leeds Enthesitis Index (LEI)	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
Proportion of participants meeting ACR 20 response	Up to 16 weeks
Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score	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 Psoriatic Area and Severity Index (PASI) 75 response	At week 16
Proportion of participants meeting achievement of Minimal Disease Activity (MDA)	At week 16
Change from baseline in Disease Activity Score 28 with C-reactive protein (DAS28-CRP) score	At week 16
Proportion of participants meeting American College of Rheumatology improvement of 70% (ACR 70) response	Up to 16 weeks
Change from baseline in PsA-modified Sharp-van der Heijde (SvdH) score	At week 16
Change from baseline in HAQ-DI score	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 meeting American College of Rheumatology improvement of 50% (ACR 50) response	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 100 response	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 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
Proportion of participants meeting achievement of total PsA-modified SvdH score of ≤ 0	At week 16
Change from baseline in SF-36 Mental Component Summary (MCS) score	Up to 16 weeks
Proportion of participants achieving Psoriatic Arthritis Response Criteria (PsARC)	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 Spondyloarthritis Research Consortium of Canada (SPARCC)	Up to 16 weeks
Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 score	Up to 16 weeks
Change from baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) score	Up to 16 weeks
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 joint space narrowing (JSN) score change of ≤ 0	At week 16
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
Proportion of participants with achievement of DAPSA disease remission	Up to 16 weeks
Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)	Up to 16 weeks
Change from baseline in domain scales scores of SF-36	Up to 16 weeks
Incidence of adverse events (AEs)	Up to 156 weeks
Change from baseline in PCS score of SF-36	Up to 16 weeks
Proportion of participants meeting achievement of MDA	Up to 16 weeks
Change from baseline in Disease Activity Index for Psoriatic Arthritis Score (DAPSA) score	Up to 16 weeks
Change from baseline in DAS28-CRP score	Up to 16 weeks
Proportion of participants meeting achievement of total PsA-modified SvdH score of ≤ 0.5	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 JSN score change of ≤ 0.5	At week 16
Change from baseline in the subcomponents of the Work Productivity and Activity Impairment (WPAI) questionnaire	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 low disease activity response	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 PsA-modified SvdH erosion score change of ≤ 0	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 MCS score of SF-36	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

Trial Locations

Locations (181)

Local Institution - 0122; 🇨🇳 Tainan, Taiwan

Local Institution - 0120; 🇨🇳 Taipei City, Taiwan

Local Institution - 0124; 🇨🇳 Taoyuan, Taiwan

Local Institution - 0106; 🇬🇧 Southampton, Hampshire, United Kingdom

Local Institution - 0116; 🇬🇧 Harlow, United Kingdom

Local Institution - 0021; 🇪🇸 A Coruña, Spain

Local Institution; 🇷🇺 Yaroslavl, Russian Federation

Local Institution - 0267; 🇧🇬 Plovdiv, Bulgaria

Local Institution - 0246; 🇧🇬 Plovdiv, Bulgaria

Local Institution - 0247; 🇧🇬 Plovdiv, Bulgaria

Local Institution - 0255; 🇧🇬 Plovdiv, Bulgaria

Local Institution - 0245; 🇧🇬 Sofia, Bulgaria

Local Institution - 0011; 🇷🇴 Cluj Napoca, Romania

Local Institution - 0258; 🇷🇴 Craiova, Romania

Local Institution - 0259; 🇧🇬 Sofia, Bulgaria

Local Institution - 0250; 🇧🇬 Varna, Bulgaria

Local Institution - 0260; 🇷🇴 Bucuresti, Romania

Local Institution - 0095; 🇲🇽 Veracruz, Mexico

Local Institution - 0264; 🇷🇴 Iasi, Romania

Local Institution - 0012; 🇷🇴 Brasov, Romania

Local Institution - 0262; 🇷🇴 Iași, Romania

Local Institution - 0265; 🇷🇴 Iași, Romania

Local Institution - 0091; 🇷🇴 Timisoara, Romania

Local Institution - 0022; 🇪🇸 Cordoba, Spain

Local Institution - 0019; 🇪🇸 Madrid, Spain

Local Institution - 0020; 🇪🇸 Sabadell, Spain

Local Institution - 0123; 🇨🇳 Kaohsiung City, Taiwan

Local Institution - 0121; 🇨🇳 Tainan City, Taiwan

Local Institution - 0167; 🇷🇴 Bucharest, Romania

Local Institution - 0263; 🇷🇴 Bucharest, Romania

Local Institution - 0184; 🇷🇴 Bucharest, Romania

Local Institution - 0168; 🇺🇸 Fontana, California, United States

Local Institution - 0083; 🇺🇸 Lexington, Kentucky, United States

Local Institution - 0197; 🇺🇸 Gilbert, Arizona, United States

Local Institution - 0188; 🇺🇸 Jonesboro, Arkansas, United States

Local Institution - 0199; 🇺🇸 Fullerton, California, United States

Local Institution - 0038; 🇺🇸 Sacramento, California, United States

Cohen Medical Centers; 🇺🇸 Thousand Oaks, California, United States

Local Institution - 0170; 🇺🇸 Denver, Colorado, United States

Local Institution - 0195; 🇺🇸 Clearwater, Florida, United States

Local Institution - 0272; 🇺🇸 Margate, Florida, United States

Local Institution - 0082; 🇺🇸 Miami Lakes, Florida, United States

Local Institution - 0171; 🇺🇸 Gainesville, Georgia, United States

Local Institution - 0087; 🇺🇸 Boise, Idaho, United States

Local Institution - 0080; 🇺🇸 Chicago, Illinois, United States

Local Institution - 0177; 🇺🇸 Orland Park, Illinois, United States

Local Institution - 0178; 🇺🇸 Schaumburg, Illinois, United States

Local Institution - 0042; 🇺🇸 Hagerstown, Maryland, United States

Local Institution - 0198; 🇺🇸 Detroit, Michigan, United States

Local Institution - 0201; 🇺🇸 Springfield, Missouri, United States

Local Institution - 0268; 🇺🇸 Kalispell, Montana, United States

Local Institution - 0186; 🇺🇸 Voorhees, New Jersey, United States

University Hospitals Cleveland Medical Center-Dermatology; 🇺🇸 Cleveland, Ohio, United States

Local Institution - 0028; 🇺🇸 Middleburg Heights, Ohio, United States

Local Institution - 0179; 🇺🇸 Perrysburg, Ohio, United States

Local Institution - 0182; 🇺🇸 Oklahoma City, Oklahoma, United States

Local Institution - 0185; 🇺🇸 Corvallis, Oregon, United States

Local Institution - 0175; 🇺🇸 Greenville, South Carolina, United States

Local Institution - 0036; 🇺🇸 Jackson, Tennessee, United States

Local Institution - 0172; 🇺🇸 Allen, Texas, United States

Local Institution - 0189; 🇺🇸 Amarillo, Texas, United States

Local Institution - 0032; 🇺🇸 Dallas, Texas, United States

Local Institution - 0273; 🇺🇸 Bothell, Washington, United States

Local Institution - 0181; 🇺🇸 Beckley, West Virginia, United States

Local Institution - 0213; 🇦🇷 Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0054; 🇦🇷 La Plata, Buenos Aires, Argentina

Local Institution - 0215; 🇦🇷 Quilmes, Buenos Aires, Argentina

Local Institution - 0046; 🇦🇷 Córdoba, Cordoba, Argentina

Local Institution - 0196; 🇦🇷 Rosario, Santa Fe, Argentina

Local Institution - 0047; 🇦🇷 San Miguel De Tucuman, Tucuman, Argentina

Local Institution - 0194; 🇦🇷 Buenos Aires, Argentina

Local Institution - 0169; 🇦🇷 Buenos Aires, Argentina

Local Institution - 0192; 🇦🇷 Ciudad Autónoma de Buenos Aires, Argentina

Local Institution - 0193; 🇦🇷 Mendoza, Argentina

Local Institution - 0220; 🇦🇺 Phillip, Australian Capital Territory, Australia

Local Institution - 0137; 🇦🇺 Botany, New South Wales, Australia

Local Institution - 0133; 🇦🇺 Westmead, New South Wales, Australia

Local Institution - 0132; 🇦🇺 Woolloongabba, Queensland, Australia

Local Institution - 0211; 🇦🇺 Hobart, Tasmania, Australia

Local Institution - 0136; 🇦🇺 Camberwell, Victoria, Australia

Local Institution - 0001; 🇧🇷 Salvador, Bahia, Brazil

Local Institution - 0109; 🇧🇷 Vitória, Espirito Santo, Brazil

Local Institution - 0002; 🇧🇷 Juiz de Fora, Minas Gerais, Brazil

Local Institution - 0219; 🇧🇷 Curitiba, Paraná, Brazil

Local Institution - 0214; 🇧🇷 Curitiba, Paraná, Brazil

Local Institution - 0005; 🇧🇷 Porto Alegre, RIO Grande DO SUL, Brazil

Local Institution - 0108; 🇧🇷 Santo Andre, São Paulo, Brazil

Local Institution - 0248; 🇧🇬 Sofia, Sofia (stolitsa), Bulgaria

Local Institution - 0253; 🇧🇬 Burgas, Bulgaria

Local Institution - 0249; 🇧🇬 Plovdiv, Bulgaria

Local Institution - 0073; 🇨🇱 Santiago, Metropolitana, Chile

Local Institution - 0111; 🇨🇱 Santiago, Metropolitana, Chile

Local Institution - 0226; 🇨🇱 Santiago, Región Metropolitana De Santiago, Chile

Local Institution - 0099; 🇨🇱 Santiago, Región Metropolitana De Santiago, Chile

Local Institution - 0222; 🇨🇱 Santiago, Región Metropolitana De Santiago, Chile

Local Institution - 0261; 🇨🇱 Viña del Mar, Valparaíso, Chile

Local Institution - 0149; 🇨🇳 Hefei, Anhui, China

Local Institution - 0159; 🇨🇳 Beijing, Beijing, China

Local Institution - 0190; 🇨🇳 Chongqing, Chongqing, China

Local Institution - 0147; 🇨🇳 Guangzhou, Guangdong, China

Local Institution - 0143; 🇨🇳 Shenzhen, Guangdong, China

Local Institution - 0150; 🇨🇳 DaLian, Liaoning, China

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

Local Institution - 0145; 🇨🇳 Yiwu, Zhejiang, China

Local Institution - 0069; 🇨🇴 Bogotá, Cundinamarca, Colombia

Local Institution - 0071; 🇨🇴 Bucaramanga, Santander, Colombia

Local Institution - 0072; 🇨🇴 Barranquilla, Colombia

Local Institution - 0063; 🇨🇴 Bogota, Colombia

Local Institution - 0070; 🇨🇴 Cali, Colombia

Local Institution - 0094; 🇨🇴 Medellin, Colombia

Local Institution - 0064; 🇨🇴 Medellin, Colombia

Local Institution - 0065; 🇨🇴 Zipaquira, Colombia

Local Institution - 0225; 🇨🇿 Praha, Praha 5, Czechia

Local Institution - 0269; 🇨🇿 Uherske Hradiste, Zlínský Kraj, Czechia

Local Institution - 0202; 🇨🇿 Zlín, Zlínský Kraj, Czechia

Local Institution - 0018; 🇨🇿 Ostrava, Czechia

Local Institution - 0208; 🇨🇿 Pardubice, Czechia

Local Institution - 0097; 🇨🇿 Praha 2, Czechia

Local Institution - 0017; 🇨🇿 Praha, Czechia

Local Institution - 0089; 🇫🇮 Kuopio, Pohjois-Savo, Finland

Local Institution - 0013; 🇫🇮 Helsinki, Finland

Local Institution - 0119; 🇫🇮 Turku, Finland

Local Institution - 0077; 🇫🇷 Chambray Les Tours, France

Local Institution - 0075; 🇫🇷 Montpellier, France

Local Institution - 0074; 🇫🇷 Paris, France

Local Institution - 0270; 🇭🇺 Gyula, Békés, Hungary

Local Institution - 0049; 🇭🇺 Székesfehérvár, Fejér, Hungary

Local Institution - 0023; 🇭🇺 Budapest, Hungary

Local Institution - 0142; 🇭🇺 Budapest, Hungary

Local Institution - 0026; 🇭🇺 Budapest, Hungary

Local Institution - 0025; 🇭🇺 Budapest, Hungary

Local Institution - 0203; 🇭🇺 Budapest, Hungary

Local Institution - 0068; 🇭🇺 Zalaegerszeg, Hungary

Local Institution - 0104; 🇮🇪 Manorhamilton, Leitrim, Ireland

Local Institution - 0101; 🇮🇪 Dublin, Ireland

Local Institution - 0102; 🇮🇪 Dublin, Ireland

Local Institution - 0103; 🇮🇪 Galway, Ireland

Local Institution - 0066; 🇮🇹 Genova, Italy

Local Institution - 0062; 🇮🇹 Pavia, Italy

Local Institution - 0096; 🇮🇹 Udine, Italy

Local Institution - 0058; 🇮🇹 Verona, Italy

Local Institution - 0056; 🇲🇽 Saltillo, Coahuila, Mexico

Local Institution - 0227; 🇲🇽 Mexico City, Distrito Federal, Mexico

Local Institution - 0057; 🇲🇽 México, Distrito Federal, Mexico

Local Institution - 0254; 🇲🇽 Guadalajara, Jalisco, Mexico

Local Institution - 0128; 🇲🇽 San Luis Potosí, SAN LUIS Potosi, Mexico

Local Institution - 0212; 🇲🇽 Merida, Yucatán, Mexico

Local Institution - 0061; 🇲🇽 Mérida, Yucatán, Mexico

Local Institution - 0060; 🇲🇽 Chihuahua, Mexico

Local Institution - 0209; 🇲🇽 Mexico City, Mexico

Local Institution - 0244; 🇵🇱 Wroclaw, Dolnośląskie, Poland

Local Institution - 0232; 🇵🇱 Lublin, Lubelskie, Poland

Local Institution - 0230; 🇵🇱 Swidnik, Lubelskie, Poland

Local Institution - 0233; 🇵🇱 Nadarzyn, Mazowieckie, Poland

Local Institution - 0235; 🇵🇱 Warszawa, Mazowieckie, Poland

Local Institution - 0243; 🇵🇱 Warszawa, Mazowieckie, Poland

Local Institution - 0236; 🇵🇱 Wołomin, Mazowieckie, Poland

Local Institution - 0229; 🇵🇱 Kraków, Małopolskie, Poland

Local Institution - 0206; 🇵🇱 Nowy Targ, Małopolskie, Poland

Local Institution - 0257; 🇵🇱 Gdansk, Pomorskie, Poland

Local Institution - 0234; 🇵🇱 Gdynia, Pomorskie, Poland

Local Institution - 0231; 🇵🇱 Dąbrówka, Wielkopolskie, Poland

Local Institution - 0114; 🇵🇱 Bialystok, Poland

Local Institution - 0140; 🇵🇱 Krakow, Poland

Local Institution - 0126; 🇵🇱 Kraków, Poland

Local Institution - 0127; 🇵🇱 Kraków, Poland

Local Institution - 0162; 🇵🇱 Olsztyn, Poland

Local Institution - 0113; 🇵🇱 Poznan, Poland

Local Institution - 0239; 🇵🇱 Poznan, Poland

Local Institution - 0112; 🇵🇱 Poznan, Poland

Local Institution - 0204; 🇵🇱 Warszawa, Poland

Local Institution - 0205; 🇵🇱 Warszawa, Poland

Local Institution - 0125; 🇵🇱 Warszawa, Poland

Local Institution - 0210; 🇵🇱 Wroclaw, Poland

Local Institution - 0238; 🇵🇱 Lodz, Łódzkie, Poland

Local Institution - 0241; 🇵🇱 Czestochowa, Śląskie, Poland

Local Institution - 0252; 🇵🇱 Katowice, Śląskie, Poland

Local Institution - 0090; 🇷🇴 Bucharest, București, Romania

Local Institution - 0266; 🇷🇴 Bucuresti, București, Romania

Local Institution - 0010; 🇷🇴 Râmnicu Vâlcea, Vâlcea, Romania

Local Institution - 0107; 🇬🇧 Stoke-on-Trent, United Kingdom