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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

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ClinicalTrials.gov Identifier: NCT04908189
Recruitment Status : Recruiting
First Posted : June 1, 2021
Last Update Posted : November 16, 2022
Sponsor:
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
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 15, 2021
Estimated Primary Completion Date : December 5, 2023
Estimated Study Completion Date : August 5, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Apremilast

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

Placebo Comparator: Placebo Drug: Deucravacitinib
Specified dose on specified days
Other Name: BMS-986165

Other: Placebo
Specified dose on specified days

Apremilast Drug: Apremilast
Specified dose on specified days
Other Name: Otezla




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 with 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) 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 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 Mental Component Summary (MCS) score [ Time Frame: Up to 16 weeks ]
  22. Change from baseline in FACIT-Fatigue score [ 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 score [ 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 score of SF-36 [ Time Frame: Up to 16 weeks ]
  38. Change from baseline in MCS score 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-5L) 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 score (short form) [ Time Frame: Up to 16 weeks ]
  43. Incidence of Adverse Events (AEs) [ Time Frame: Up to week 156 ]
  44. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to week 156 ]


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.


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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 (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

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): NCT04908189


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT # and site #.

Locations
Show Show 145 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04908189    
Other Study ID Numbers: IM011-055
2020-005099-36 ( EudraCT Number )
U1111-1259-9466 ( Registry Identifier: WHO )
First Posted: June 1, 2021    Key Record Dates
Last Update Posted: November 16, 2022
Last Verified: November 2022

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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:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
BMS-986165
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Phosphodiesterase 4 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Protein Kinase Inhibitors