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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

  • Clinicaltrials.gov identifier

    NCT04908189

  • Recruitment Status

    Recruiting

  • First Posted

    June 1, 2021

  • Last update posted

    December 21, 2021

Study Description

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.

  • Condition or Disease:Psoriatic Arthritis
  • Intervention/Treatment: Drug: Deucravacitinib
    Other: Placebo
    Drug: Apremilast
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 700 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment
  • Actual Study Start Date: July 2021
  • Estimated Primary Completion Date: October 2023
  • Estimated Study Completion Date: July 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Deucravacitinib
Drug: Deucravacitinib
Specified dose on specified days
Placebo Comparator: Placebo
Drug: Deucravacitinib
Specified dose on specified days

Other: Placebo
Specified dose on specified days
Other: Apremilast
Drug: Apremilast
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20) [ Time Frame: At week 16 ]
  • Secondary Outcome Measures: 1. Change from baseline Disease Activity Score 28 and C-Reactive Protein (DAS28-CRP) [ Time Frame: At week 16 ]
  • 2. Change from baseline Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: At week 16 ]
  • 3. Proportion of participants meeting Psoriatic Area and Severity Index (PASI) 75 response [ Time Frame: At week 16 ]
  • 4. Change from baseline Short Form-36 Physical Component Survey (SF-36 PCS) [ Time Frame: At week 16 ]
  • 5. Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Leeds Enthesitis Index (LEI) [ Time Frame: At week 16 ]
  • 6. Proportion of participants meeting achievement of Minimal Disease Activity (MDA) [ Time Frame: At week 16 ]
  • 7. Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue [ Time Frame: At week 16 ]
  • 8. Proportion of participants meeting dactylitis resolution among the participants with dactylitis at baseline [ Time Frame: At week 16 ]
  • 9. Proportion of participants meeting ACR 20 response [ Time Frame: Up to 16 weeks ]
  • 10. Proportion of participants meeting American College of Rheumatology improvement of 50% (ACR 50) response [ Time Frame: Up to 16 weeks ]
  • 11. Proportion of participants meeting American College of Rheumatology improvement of 70% (ACR 70) response [ Time Frame: Up to 16 weeks ]
  • 12. Change from baseline in HAQ-DI score [ Time Frame: Up to 16 weeks ]
  • 13. 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 [ Time Frame: Up to 16 weeks ]
  • 14. Proportion of participants meeting PASI 75 response [ Time Frame: Up to 16 weeks ]
  • 15. Proportion of participants meeting PASI 90 response [ Time Frame: Up to 16 weeks ]
  • 16. Proportion of participants meeting PASI 100 response [ Time Frame: Up to 16 weeks ]
  • 17. Change from baseline in the SF-36 PCS score [ Time Frame: Up to 16 weeks ]
  • 18. Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by LEI [ Time Frame: Up to 16 weeks ]
  • 19. Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) [ Time Frame: Up to 16 weeks ]
  • 20. Proportion of participants meeting achievement of MDA [ Time Frame: Up to 16 weeks ]
  • 21. Change from baseline in SF-36 Score Mental Component Summary (MCS) [ Time Frame: Up to 16 weeks ]
  • 22. Change from baseline in FACIT-Fatigue [ Time Frame: Up to 16 weeks ]
  • 23. Proportion of participants meeting dactylitis resolution among the participants with dactylitis at baseline [ Time Frame: Up to 16 weeks ]
  • 24. Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 [ Time Frame: Up to 16 weeks ]
  • 25. Change from baseline in Disease Activity Index for Psoriatic Arthritis Score (DAPSA) score [ Time Frame: Up to 16 weeks ]
  • 26. Proportion of participants with achievement of DAPSA low disease activity response [ Time Frame: Up to 16 weeks ]
  • 27. Proportion of participants with achievement of DAPSA disease remission [ Time Frame: Up to 16 weeks ]
  • 28. 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 [ Time Frame: Up to 16 weeks ]
  • 29. Change from baseline in DAS28-CRP score [ Time Frame: Up to 16 weeks ]
  • 30. Proportion of participants with achievement of a DAS28-CRP low disease activity response [ Time Frame: Up to 16 weeks ]
  • 31. Proportion of participants with achievement of a DAS28-CRP disease remission [ Time Frame: Up to 16 weeks ]
  • 32. Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) [ Time Frame: Up to 16 weeks ]
  • 33. Change from baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) score [ Time Frame: Up to 16 weeks ]
  • 34. Proportion of participants achieving Psoriatic Arthritis Response Criteria (PsARC) [ Time Frame: Up to 16 weeks ]
  • 35. 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 [ Time Frame: Up to 16 weeks ]
  • 36. Change from baseline in domain scales scores of SF-36 [ Time Frame: Up to 16 weeks ]
  • 37. Change from baseline in PCS of SF-36 [ Time Frame: Up to 16 weeks ]
  • 38. Change from baseline in MCS of SF- 36 [ Time Frame: Up to 16 weeks ]
  • 39. Change from baseline in the subcomponents of the Work Productivity and Activity Impairment (WPAI) questionnaire [ Time Frame: Up to 16 weeks ]
  • 40. Change from baseline in the 5-level EuroQoL 5-dimension (EQ-5D) utility scores [ Time Frame: Up to 16 weeks ]
  • 41. Change from baseline in the 5-level EQ-5D utility score subcomponents [ Time Frame: Up to 16 weeks ]
  • 42. Change from baseline in Patient- Reported Outcome Measures Information System (PROMIS) sleep disturbance (short form) [ Time Frame: Up to 16 weeks ]
  • 43. Incidence of Adverse Events (AEs) [ Time Frame: Up to Week 52 ]
  • 44. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to Week 52 ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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 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

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of email MUST contain NCT # and site #.

Locations

United States, Alabama
Local Institution
Birmingham

United States, California
Local Institution
Fountain Valley

United States, Maryland
Local Institution
Cumberland

United States, Michigan
Advanced Rheumatology, PC
Lansing

United States, Minnesota
Saint Paul Rheumatology
Eagan

United States, Mississippi
Arthritis Associates
Hattiesburg

United States, New York
Local Institution
New York

United States, Pennsylvania
Altoona Center For Clinical Research
Duncansville

United States, Texas
Local Institution
Lubbock

United States, Texas
Southwest Rheumatology Research
Mesquite

United States, Washington
Local Institution
Seattle

United States, Wisconsin
Local Institution
Glendale

Argentina, Buenos Aires
Local Institution
C.a.b.a.

Argentina, Buenos Aires
Local Institution
La Plata

Argentina, Buenos Aires
Local Institution
San Isidro

Argentina, Tucuman
Local Institution
San Miguel de Tucumán

Argentina
Local Institution
Buenos Aires

Argentina
Local Institution
Cordoba

Australia, New South Wales
Emeritus Research
Botany

Australia, New South Wales
BJC Health
Parramatta

Australia, Queensland
Local Institution
Maroochydore

Australia, South Australia
Local Institution
Woodville South

Australia, Victoria
Emeritus Research
Camberwell

Australia, Victoria
Barwon Rheumatology Service
Geelong

Belgium
Local Institution
Brussel

Belgium
Local Institution
Gent

Belgium
Local Institution
Leuven

Belgium
Local Institution
Liège

Canada, British Columbia
Local Institution
Vancouver

Canada, Ontario
Local Institution
Hamilton

Canada, Ontario
Local Institution
Markham

Canada, Ontario
Local Institution
Waterloo

Canada
Local Institution
Quebec

China, Anhui
Local Institution
Bengbu

China, Beijing
Local Institution
Beijing

China, Beijing
Local Institution
Beijing

China, Guangdong
Local Institution
Guangzhou

China, Guangdong
Local Institution
Guangzhou

China, Henan
Local Institution
Zhengzhou

China, Hunan
Local Institution
Changsha

China, Hunan
Local Institution
Changsha

China, Jiangsu
Local Institution
Changzhou

China, Jiangsu
Local Institution
Nanjing

China, Jiangsu
Local Institution
Nantong

China, Jiangsu
Local Institution
Wuxi

China, Jiangxi
Local Institution
Jiujiang

China, Jiangxi
Local Institution
Nanchang

China, Jiangxi
Local Institution
Nanchang

China, Jiangxi
Local Institution
Pingxiang

China, Neimeng
Local Institution
Baotou

China, Neimeng
Local Institution
Hohhot

China, Shan3xi
Local Institution
Xi'an

China, Sichuan
Local Institution
Chengdu

China, Xinjiang
Local Institution
Urumqi

China, Yunnan
Local Institution
Kunming

China, Zhejiang
Local Institution
Wenzhou

Colombia
Local Institution
Barranquilla

Colombia
Local Institution
Cali

Colombia
Local Institution
Chapinero

Colombia
Local Institution
Chia

Colombia
Local Institution
Medellin

Czechia
Revmatologie s.r.o.
Brno

Czechia
Vesalion
Ostrava

Czechia
CCR Ostrava s.r.o.
Ostrava

Czechia
Local Institution
Praha

Czechia
MEDICAL PLUS, s.r.o.
Uherske Hradiste

Germany
Local Institution
Bonn

Germany
Local Institution
Düsseldorf

Germany
Local Institution
Gera

Germany
MVZ Rheuma
Hamburg

Germany
Local Institution
Hamburg

Germany
Local Institution
Köln

Germany
Smo.Md Gmbh
Magdeburg

Germany
Local Institution
Ratingen

Germany
Uniklinik Tuebingen
Tuebingen

Hungary
Local Institution
Debrecen

Hungary
Local Institution
Gyula

Hungary
Local Institution
Kistarcsa

Hungary
Local Institution
Szentes

Hungary
Local Institution
Veszprem

Italy
Local Institution
Firenze

Italy
Local Institution
Potenza

Italy
Local Institution
Roma

Japan, Aichi
Local Institution
Nagoya-shi

Japan, Hokkaido
Local Institution
Sapporo

Japan, MIE
Local Institution
Tsu

Japan, Osaka
Local Institution
Kawachinagano

Japan, Tokyo
Local Institution
Chuo-ku

Japan, Tokyo
Local Institution
Itabashi-ku

Japan, Tokyo
Local Institution
Meguro-ku

Japan, Tokyo
Local Institution
Minato-ku

Japan, Tokyo
Local Institution
Mitaka

Japan, Tokyo
Local Institution
Shinjuku-ku

Japan
Local Institution
Fukuoka

Japan
Local Institution
Osaka

Mexico, Guanajuato
Local Institution
León

Mexico, Jalisco
Local Institution
Guadalajara

Mexico, Jalisco
Local Institution
Zapopan

Mexico, Yucatan
Local Institution
Merida

Mexico
Local Institution
Chihuahua

Poland
Local Institution
Bydgoszcz

Poland
Local Institution
Elblag

Poland
Local Institution
Gdansk

Poland
Local Institution
Torun

Poland
Local Institution
Warszawa

Poland
Local Institution
Wroc£aw

Russian Federation
Local Institution
Ekaterinburg

Russian Federation
Local Institution
Kazan

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Novosibirsk

Russian Federation
Local Institution
Novosibirsk

Russian Federation
Local Institution
Saint Petersburg

Russian Federation
Local Institution
Saint-Petersburg

Russian Federation
Local Institution
Vladimir

Spain
Local Institution
Barcelona

Spain
Local Institution
Madrid

Spain
Local Institution
Santander

Spain
Local Institution
Valencia

Taiwan
Local Institution
Taichung

Taiwan
Local Institution
Taichung

Taiwan
Local Institution
Taichung

Taiwan
Local Institution
Taipei

Taiwan
Local Institution
Taipei

United Kingdom
Local Institution
Bradford

United Kingdom
Local Institution
Hull

United Kingdom
Local Institution
Liverpool

United Kingdom
Local Institution
London

United Kingdom
Local Institution
Manchester

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04908189 History of Changes
  • Other Study ID Numbers: IM011-055, 2020-005099-36, U1111-1259-9466
  • First Posted: June 1, 2021 Key Record Dates
  • Last Update Posted: December 21, 2021
  • Last Verified: December 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Psoriatic arthritis
    PsA
    Deucravacitinib
    BMS-986165
    Apremilast
    Otezla
  • Additional relevant MeSH terms: Arthritis
    Arthritis, Psoriatic
    Joint Diseases
    Musculoskeletal Diseases
    Spondylarthropathies
    Spondylarthritis
    Spondylitis
    Spinal Diseases
    Bone Diseases
    Psoriasis
    Skin Diseases, Papulosquamous
    Skin Diseases