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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

  • Clinicaltrials.gov identifier

    NCT04908202

  • 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 efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs.

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

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 650 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: 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
  • 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
Other: Placebo
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR 20) response [ Time Frame: At week 16 ]
  • Secondary Outcome Measures: 1. Change from baseline in Disease Activity Score 28 with C-reactive protein (DAS28-CRP) score [ Time Frame: At week 16 ]
  • 2. Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score [ 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 in the 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 at week 16 among the participants with dactylitis at baseline [ Time Frame: At week 16 ]
  • 9. Change from baseline in PsA-modified Sharp-van der Heijde (SvdH) score [ Time Frame: At week 16 ]
  • 10. Proportion of participants meeting ACR 20 response [ Time Frame: Up to 16 weeks ]
  • 11. Proportion of participants meeting American College of Rheumatology improvement of 50% (ACR 50) response [ Time Frame: Up to 16 weeks ]
  • 12. Proportion of participants meeting American College of Rheumatology improvement of 70% (ACR 70) response [ Time Frame: Up to 16 weeks ]
  • 13. Change from baseline in HAQ-DI score [ Time Frame: Up to 16 weeks ]
  • 14. 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 ]
  • 15. Proportion of participants with achievement of PASI 75 response [ Time Frame: Up to 16 weeks ]
  • 16. Proportion of participants with achievement of PASI 90 response [ Time Frame: Up to 16 weeks ]
  • 17. Proportion of participants with achievement of PASI 100 response [ Time Frame: Up to 16 weeks ]
  • 18. Change from baseline in the SF-36 PCS score [ Time Frame: Up to 16 weeks ]
  • 19. Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by LEI [ Time Frame: Up to 16 weeeks ]
  • 20. 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 ]
  • 21. Proportion of participants meeting achievement of MDA [ Time Frame: Up to 16 weeks ]
  • 22. Change from baseline in SF-36 Score Mental Component Summary (MCS) [ Time Frame: Up to 16 weeks ]
  • 23. Change from baseline in FACIT-Fatigue [ Time Frame: Up to 16 weeks ]
  • 24. Proportion of participants meeting dactylitis resolution among the participants with dactylitis at baseline [ Time Frame: Up to 16 weeks ]
  • 25. Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 [ Time Frame: Up to 16 weeks ]
  • 26. Change from baseline in Disease Activity Index for Psoriatic Arthritis Score (DAPSA) score [ Time Frame: Up to 16 weeks ]
  • 27. Proportion of participants with achievement of DAPSA low disease activity response [ Time Frame: Up to 16 weeks ]
  • 28. Proportion of participants with achievement of DAPSA disease remission [ Time Frame: Up to 16 weeks ]
  • 29. 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 ]
  • 30. Change from baseline in DAS28-CRP score [ Time Frame: Up to 16 weeks ]
  • 31. Proportion of participants with achievement of a DAS28-CRP low disease activity response [ Time Frame: Up to 16 weeks ]
  • 32. Proportion of participants with achievement of a DAS28-CRP disease remission [ Time Frame: Up to 16 weeks ]
  • 33. Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) [ Time Frame: Up to 16 weeks ]
  • 34. Change from baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) score [ Time Frame: Up to 16 weeks ]
  • 35. Proportion of participants achieving Psoriatic Arthritis Response Criteria (PsARC) [ Time Frame: Up to 16 weeks ]
  • 36. 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 ]
  • 37. Proportion of participants meeting achievement of total PsA-modified SvdH score of ≤ 0 [ Time Frame: At week 16 ]
  • 38. Proportion of participants meeting achievement of total PsA-modified SvdH score of ≤ 0.5 [ Time Frame: At week 16 ]
  • 39. Proportion of participants meeting achievement of total PsA-modified SvdH score of ≤ smallest detectable change (SDC) [ Time Frame: At week 16 ]
  • 40. Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of ≤ 0 [ Time Frame: At week 16 ]
  • 41. Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of ≤ 0.5 [ Time Frame: At week 16 ]
  • 42. Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of ≤ SDC [ Time Frame: At week 16 ]
  • 43. Proportion of participants meeting achievement of PsA-modified SvdH joint space narrowing (JSN) score change of ≤ 0 [ Time Frame: At week 16 ]
  • 44. Proportion of participants meeting achievement of PsA-modified SvdH JSN score change of ≤ 0.5 [ Time Frame: At week 16 ]
  • 45. Proportion of participants meeting achievement of PsA-modified SvdH JSN score change of ≤ SDC [ Time Frame: At week 16 ]
  • 46. Change in PsA-modified SvdH erosion score from baseline [ Time Frame: At week 16 ]
  • 47. Change in PsA-modified SvdH JSN score [ Time Frame: At week 16 ]
  • 48. Change from baseline in domain scales scores of SF-36 [ Time Frame: Up to 16 weeks ]
  • 49. Change from baseline in PCS of SF-36 [ Time Frame: Up to 16 weeks ]
  • 50. Change from baseline in MCS of SF-36 [ Time Frame: Up to 16 weeks ]
  • 51. Change from baseline in the subcomponents of the Work Productivity and Activity Impairment (WPAI) questionnaire [ Time Frame: Up to 16 weeks ]
  • 52. Change from baseline in the 5-level EuroQoL 5-dimension (EQ-5D) utility scores [ Time Frame: Up to 16 weeks ]
  • 53. Change from baseline in the 5-level EQ-5D utility score subcomponents [ Time Frame: Up to 16 weeks ]
  • 54. Change from baseline in Patient-Reported Outcome Measures Information System (PROMIS) sleep disturbance (short form) [ Time Frame: Up to 16 weeks ]
  • 55. Incidence of adverse events (AEs) [ Time Frame: Up to 52 weeks ]
  • 56. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 52 weeks ]

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 ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading 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 the email MUST contain NCT # and Site #.

Locations

United States, California
Local Institution
Fountain Valley

United States, California
Local Institution
Los Angeles

United States, California
Local Institution
Palm Desert

United States, California
Local Institution
Sacramento

United States, Colorado
Local Institution
Denver

United States, Florida
San Marcus Research Clinic, Inc.
Miami Lakes

United States, Idaho
Local Institution
Boise

United States, Illinois
Great Lakes Clinical Trials - West Wilson Avenue
Chicago

United States, Kentucky
Arthritis Center of Lexington-Bluegrass Community Research, Inc.
Lexington

United States, Maryland
Local Institution
Hagerstown

United States, New Jersey
Local Institution
Toms River

United States, Ohio
Local Institution
Cleveland

United States, Ohio
Paramount Medical Research & Consulting, Llc
Middleburg Heights

United States, Tennessee
Local Institution
Jackson

United States, Texas
Metroplex Clinical Research Center
Dallas

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

Argentina, Buenos Aires
Local Institution
Ciudad Autonoma de Buenos Aires

Argentina, Cordoba
Local Institution
Córdoba

Argentina, Distrito Federal
Local Institution
DQG

Argentina, Tucuman
Local Institution
San Miguel de Tucumán

Argentina
Local Institution
Cordoba

Australia, New South Wales
Optimus Clinical Research Pty Ltd
Botany

Australia, New South Wales
Local Institution
Westmead

Australia, Queensland
Veracity Clinical Research
Brisbane

Australia, Victoria
Emeritus Research
Camberwell

Australia, Victoria
Local Institution
Clayton

Brazil, Bahia
Local Institution
Salvador

Brazil, Espirito Santo
Local Institution
Vitoria

Brazil, Minas Gerais
Local Institution
Juiz de Fora

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil
Local Institution
Sao Paulo

Chile, Metropolitana
Local Institution
Providencia

Chile, Metropolitana
Local Institution
Santiago

Chile, Metropolitana
Local Institution
Santiago

China, Anhui
Local Institution
Hefei

China, Beijing
Local Institution
Beijing

China, Guangdong
Local Institution
Guangzhou

China, Guangdong
Local Institution
Shenzhen

China, Liaoning
Local Institution
Dalian

China, Shanghai
Local Institution
Shanghai

China, Shanghai
Local Institution
Shanghai

China, Zhejiang
Local Institution
Yiwu

Colombia
Local Institution
Barranquilla

Colombia
Local Institution
Bogota

Colombia
Local Institution
Bogota

Colombia
Local Institution
Bucaramanga

Colombia
Local Institution
Cali

Colombia
Local Institution
Medellín

Colombia
Local Institution
Zipaquira

Czechia
Artroscan, s.r.o.
Ostrava-Trebovice

Czechia
Local Institution
Pardubice

Czechia
Revmatologicky ustav-Rheumatology
Prague

Czechia
CCR Prague, s.r.o.
Praha 3

Finland
Local Institution
Helsinki

Finland
Local Institution
Kuopio

Finland
Local Institution
Turku

France
Local Institution
Chambray les Tours

France
Local Institution
Montpellier

France
Local Institution
Paris

Hungary
Local Institution
Budapest

Hungary
Local Institution
Budapest

Hungary
Local Institution
Budapest

Hungary
Local Institution
Budapest

Hungary
Local Institution
Szekesfehervar

Hungary
Local Institution
Zalaegerszeg

Ireland, Leitrim
Local Institution
Manorhamilton

Ireland
Local Institution
Dublin

Ireland
Local Institution
Dublin

Ireland
Local Institution
Galway

Italy
Local Institution
Genova

Italy
Local Institution
Pavia

Italy
Local Institution
Udine

Italy
Local Institution
Verona

Mexico, Coahuila
Local Institution
Saltillo

Mexico, Distrito Federal
Local Institution
Ciudad de México

Mexico, Yucatan
Local Institution
Merida

Mexico
Local Institution
Chihuahua

Mexico
Local Institution
San Luis Potosi

Mexico
Local Institution
Veracruz

Poland
Local Institution
Bialystok

Poland
Local Institution
Krakow

Poland
Local Institution
Kraków

Poland
Local Institution
Olsztyn

Poland
Local Institution
Poznan

Poland
Local Institution
Poznan

Poland
Local Institution
Warszawa

Romania
Local Institution
Brasov

Romania
Local Institution
Bucharest

Romania
Local Institution
Bucharest

Romania
Local Institution
Cluj Napoca

Romania
Local Institution
Râmnicu Vâlcea

Romania
Local Institution
Timisoara

Russian Federation
Local Institution
Chelyabinsk

Russian Federation
Local Institution
Kazan

Russian Federation
Local Institution
Kemerovo

Russian Federation
Local Institution
Korolev

Russian Federation
Local Institution
Korolev

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Novosibirsk

Russian Federation
Local Institution
Ryazan

Russian Federation
Local Institution
Saint Petersburg

Russian Federation
Local Institution
Saratov

Russian Federation
Local Institution
Yaroslavl

Spain
Local Institution
A Coruna

Spain
Local Institution
Cordoba

Spain
Local Institution
Madrid

Spain
Local Institution
Sabadell

Taiwan
Local Institution
Kaohsiung City

Taiwan
Local Institution
Tainan

Taiwan
Local Institution
Tainan

Taiwan
Local Institution
Taipei

Taiwan
Local Institution
Taoyuan

United Kingdom
Local Institution
Harlow

United Kingdom
Local Institution
Southampton

United Kingdom
Local Institution
Stoke on Trent

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: NCT04908202 History of Changes
  • Other Study ID Numbers: IM011-054, 2020-005097-10, U1111-1259-9443
  • 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: Biologic-Naive
    BMS-986165
    Deucravacitinib
    Disease-modifying Anti-rheumatic Drugs
    DMARDs
    Joint Disease
    Psoriatic Arthritis
    PsA
  • Additional relevant MeSH terms: Arthritis
    Arthritis, Psoriatic
    Rheumatic Diseases
    Joint Diseases
    Musculoskeletal Diseases
    Spondylarthropathies
    Spondylarthritis
    Spondylitis
    Spinal Diseases
    Bone Diseases
    Psoriasis
    Skin Diseases, Papulosquamous
    Skin Diseases
    Connective Tissue Diseases