Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04908202
Recruitment Status : Recruiting
First Posted : June 1, 2021
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Drug: Deucravacitinib Other: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 13, 2021
Estimated Primary Completion Date : January 16, 2024
Estimated Study Completion Date : October 13, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Deucravacitinib Drug: Deucravacitinib
Specified dose on specified days
Other Name: BMS-986165

Placebo Comparator: Placebo Other: Placebo
Specified dose on specified days




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) score [ 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 score [ 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 Mental Component Summary (MCS) score [ Time Frame: Up to 16 weeks ]
  23. Change from baseline in FACIT-Fatigue score [ 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 score [ 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 score of SF-36 [ Time Frame: Up to 16 weeks ]
  50. Change from baseline in MCS score 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-5L utility score subcomponents [ Time Frame: Up to 16 weeks ]
  54. Change from baseline in Patient-Reported Outcome Measures Information System (PROMIS) sleep disturbance score (short form) [ Time Frame: Up to 16 weeks ]
  55. Incidence of adverse events (AEs) [ Time Frame: Up to 156 weeks ]
  56. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 156 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04908202


Contacts
Layout table for location contacts
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
Show Show 122 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04908202    
Other Study ID Numbers: IM011-054
2020-005097-10 ( EudraCT Number )
U1111-1259-9443 ( Registry Identifier: WHO )
First Posted: June 1, 2021    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022

Layout table for additional information
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:
Layout table for 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
BMS-986165
Dermatologic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action