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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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04908189
Collaborator
(none)
700
Enrollment
137
Locations
3
Arms
59.8
Anticipated Duration (Months)
5.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.The long term extension period will provide additional long-term safety and efficacy information.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Jul 15, 2021
Anticipated Primary Completion Date :
Oct 16, 2023
Anticipated Study Completion Date :
Jul 9, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Deucravacitinib

Drug: Deucravacitinib
Specified dose on specified days
Other Names:
  • BMS-986165

    		•
    Placebo Comparator: Placebo

    Drug: Deucravacitinib
    Specified dose on specified days
    Other Names:
  • BMS-986165

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

    Drug: Apremilast
    Specified dose on specified days
    Other Names:
  • Otezla

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20) [At week 16]

    Secondary Outcome Measures

    1. Change from baseline Disease Activity Score 28 with C-Reactive Protein (DAS28-CRP) [At week 16]

    2. Change from baseline Health Assessment Questionnaire - Disability Index (HAQ-DI) [At week 16]

    3. Proportion of participants meeting Psoriatic Area and Severity Index (PASI) 75 response [At week 16]

    4. Change from baseline Short Form-36 Physical Component Survey (SF-36 PCS) score [At week 16]

    5. Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Leeds Enthesitis Index (LEI) [At week 16]

    6. Proportion of participants meeting achievement of Minimal Disease Activity (MDA) [At week 16]

    7. Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score [At week 16]

    8. Proportion of participants meeting dactylitis resolution among the participants with dactylitis at baseline [At week 16]

    9. Proportion of participants meeting ACR 20 response [Up to 16 weeks]

    10. Proportion of participants meeting American College of Rheumatology improvement of 50% (ACR 50) response [Up to 16 weeks]

    11. Proportion of participants meeting American College of Rheumatology improvement of 70% (ACR 70) response [Up to 16 weeks]

    12. Change from baseline in HAQ-DI score [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 [Up to 16 weeks]

    14. Proportion of participants meeting PASI 75 response [Up to 16 weeks]

    15. Proportion of participants meeting PASI 90 response [Up to 16 weeks]

    16. Proportion of participants meeting PASI 100 response [Up to 16 weeks]

    17. Change from baseline in the SF-36 PCS score [Up to 16 weeks]

    18. Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by LEI [Up to 16 weeks]

    19. Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) [Up to 16 weeks]

    20. Proportion of participants meeting achievement of MDA [Up to 16 weeks]

    21. Change from baseline in SF-36 Mental Component Summary (MCS) score [Up to 16 weeks]

    22. Change from baseline in FACIT-Fatigue score [Up to 16 weeks]

    23. Proportion of participants meeting dactylitis resolution among the participants with dactylitis at baseline [Up to 16 weeks]

    24. Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 score [Up to 16 weeks]

    25. Change from baseline in Disease Activity Index for Psoriatic Arthritis Score (DAPSA) score [Up to 16 weeks]

    26. Proportion of participants with achievement of DAPSA low disease activity response [Up to 16 weeks]

    27. Proportion of participants with achievement of DAPSA disease remission [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 [Up to 16 weeks]

    29. Change from baseline in DAS28-CRP score [Up to 16 weeks]

    30. Proportion of participants with achievement of a DAS28-CRP low disease activity response [Up to 16 weeks]

    31. Proportion of participants with achievement of a DAS28-CRP disease remission [Up to 16 weeks]

    32. Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) [Up to 16 weeks]

    33. Change from baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) score [Up to 16 weeks]

    34. Proportion of participants achieving Psoriatic Arthritis Response Criteria (PsARC) [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 [Up to 16 weeks]

    36. Change from baseline in domain scales scores of SF-36 [Up to 16 weeks]

    37. Change from baseline in PCS score of SF-36 [Up to 16 weeks]

    38. Change from baseline in MCS score of SF- 36 [Up to 16 weeks]

    39. Change from baseline in the subcomponents of the Work Productivity and Activity Impairment (WPAI) questionnaire [Up to 16 weeks]

    40. Change from baseline in the 5-level EuroQoL 5-dimension (EQ-5D-5L) utility scores [Up to 16 weeks]

    41. Change from baseline in the 5-level EQ-5D utility score subcomponents [Up to 16 weeks]

    42. Change from baseline in Patient- Reported Outcome Measures Information System (PROMIS) sleep disturbance score (short form) [Up to 16 weeks]

    43. Incidence of Adverse Events (AEs) [Up to week 156]

    44. Incidence of Serious Adverse Events (SAEs) [Up to week 156]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rheumatology Associates, Pc Birmingham Alabama United States 35205
    2 Local Institution Fountain Valley California United States 92708
    3 Medvin Clinical Research - Su-Research Whittier California United States 90602
    4 Klein And Associates, M.D., Pa Cumberland Maryland United States 21502
    5 Advanced Rheumatology, PC Lansing Michigan United States 48910
    6 Saint Paul Rheumatology Eagan Minnesota United States 55121
    7 Arthritis Associates Hattiesburg Mississippi United States 39402
    8 Icahn School of Medicine at Mount Sinai-Department of Dermatology New York New York United States 10003
    9 University Hospitals Cleveland Medical Center-Medicine Cleveland Ohio United States 44106
    10 Rheumatology Associates of Oklahoma Oklahoma City Oklahoma United States 73116
    11 Local Institution Portland Oregon United States 97239
    12 Altoona Center For Clinical Research Duncansville Pennsylvania United States 16635
    13 West Texas Clinical Research Lubbock Texas United States 79410
    14 Southwest Rheumatology Research Mesquite Texas United States 75150
    15 Trinity Universal Research Associates Plano Texas United States 75024
    16 Local Institution Seattle Washington United States 98122
    17 Local Institution Seattle Washington United States 98195
    18 Rheumatic Disease Center Milwaukee Wisconsin United States 53217
    19 Local Institution C.a.b.a. Buenos Aires Argentina 1431
    20 Local Institution - 0048 La Plata Buenos Aires Argentina 1900
    21 Local Institution - 0038 San Isidro Buenos Aires Argentina 1642
    22 Local Institution - 0039 Caba Distrito Federal Argentina C1015
    23 Local Institution - 0171 San Miguel de Tucumán Tucuman Argentina 4000
    24 Local Institution Cordoba Argentina
    25 Emeritus Research Botany New South Wales Australia 2019
    26 Local Institution - 0018 Paramatta New South Wales Australia 2150
    27 Rheumatology Research Unit Sunshine Coast Maroochydore Queensland Australia 4558
    28 Local Institution - 0099 Woodville South Australia Australia 5011
    29 Local Institution - 0002 Camberwell Victoria Australia 3124
    30 Local Institution - 0017 Geelong Victoria Australia 3220
    31 Local Institution Brussel Belgium 1200
    32 Local Institution Gent Belgium 9000
    33 Local Institution Leuven Belgium 3000
    34 Local Institution Liège Belgium 4000
    35 Local Institution Vancouver British Columbia Canada V5Z4E8
    36 Local Institution - 0006 Hamilton Ontario Canada L8N 1Y2
    37 Local Institution - 0030 Markham Ontario Canada L3P 1X2
    38 Local Institution Toronto Ontario Canada M5T 2S6
    39 Local Institution Waterloo Ontario Canada N2J 1C4
    40 Local Institution - 0001 Quebec Canada G1V 3M7
    41 Local Institution Bengbu Anhui China 233004
    42 Local Institution - 0152 Beijing Beijing China 100083
    43 Local Institution - 0146 Beijing Beijing China 100730
    44 Local Institution Guangzhou Guangdong China 510000
    45 Local Institution Guangzhou Guangdong China 510317
    46 Local Institution Zhengzhou Henan China 450000
    47 Local Institution Changsha Hunan China 410008
    48 Local Institution Changsha Hunan China 410021
    49 Local Institution - 0125 Changzhou Jiangsu China 213003
    50 Local Institution - 0138 Nanjing Jiangsu China 210029
    51 Local Institution Nantong Jiangsu China 226001
    52 Local Institution - 0163 Wuxi Jiangsu China 214023
    53 Local Institution - 0148 Jiujiang Jiangxi China 332000
    54 Local Institution - 0131 Nanchang Jiangxi China 330006
    55 Local Institution - 0156 Nanchang Jiangxi China 330006
    56 Local Institution - 0140 Pingxiang Jiangxi China 337055
    57 Local Institution - 0158 Baotou Neimeng China 014010
    58 Local Institution - 0157 Hohhot Neimeng China 010050
    59 Local Institution - 0154 Xi'An Shan3xi China 710004
    60 Local Institution - 0164 Chengdu Sichuan China 610072
    61 Local Institution - 0117 Urumqi Xinjiang China 830001
    62 Local Institution - 0134 Kunming Yunnan China 650032
    63 Local Institution Wenzhou Zhejiang China 325000
    64 Local Institution - 0020 Cali Valle Del Cauca Colombia 760035
    65 Local Institution - 0072 Barranquilla Colombia 80002
    66 Local Institution - 0015 Bogotá Colombia 110221
    67 Local Institution - 0022 Chía Colombia 250001
    68 Local Institution Medellin Colombia 050034
    69 Local Institution - 0010 Brno Czechia 638 00
    70 Local Institution - 0009 Ostrava Czechia 702 00
    71 Local Institution - 0035 Ostrava Czechia 702 00
    72 Local Institution - 0011 Praha 2 Czechia 12850
    73 Local Institution - 0023 Uherske Hradiste Czechia 686 01
    74 Local Institution Bonn Germany 53127
    75 Local Institution Düsseldorf Germany 40225
    76 Local Institution Gera Germany 07548
    77 Local Institution - 0046 Hamburg Germany 20095
    78 Local Institution Hamburg Germany 22391
    79 Universitaetsklinikum Koeln-Medizinische Klinik I fuer Innere Medizin Köln Germany 50937
    80 Smo.Md Gmbh Magdeburg Germany 39120
    81 Local Institution - 0176 Ratingen Germany 40878
    82 Local Institution - 0074 Tübingen Germany 72076
    83 Local Institution - 0066 Debrecen Hungary 4032
    84 Local Institution - 0028 Gyula Hungary 5700
    85 Local Institution - 0027 Kistarcsa Hungary 2143
    86 Local Institution - 0024 Szarvas Hungary 6600
    87 Local Institution - 0025 Veszprem Hungary 8200
    88 Azienda Ospedaliera Universitaria Careggi-Reumatologia Firenze Italy 50141
    89 AOR San Carlo di Potenza-UOC Reumatologia Potenza Italy 85100
    90 Fondazione Policlinico Universitario Agostino Gemelli-UOC Reumatologia Roma Italy 00168
    91 Local Institution - 0106 Nagoya-shi Aichi Japan 4678602
    92 Local Institution - 0155 Fukuoka, Jonan-Ku Fukuoka Japan 814-0180
    93 Local Institution - 0151 Sapporo Hokkaido Japan 060-8638
    94 Local Institution Tsu MIE Japan 514-8507
    95 Local Institution - 0123 Kawachinagano Osaka Japan 586-8521
    96 Local Institution Chuo-ku Tokyo Japan 104-8560
    97 Local Institution Itabashi-ku Tokyo Japan 173-0003
    98 Local Institution - 0178 Meguro-ku Tokyo Japan 153-8515
    99 Local Institution Minato-ku Tokyo Japan 105-8471
    100 Local Institution Mitaka Tokyo Japan 181-8611
    101 Local Institution - 0065 Shinjuku-ku Tokyo Japan 1600016
    102 Local Institution - 0166 Osaka Japan 545-8585
    103 Local Institution - 0052 Leon Guanajuato Mexico 37160
    104 Local Institution - 0051 Guadalajara Jalisco Mexico 44650
    105 Local Institution - 0057 Zapopan Jalisco Mexico 45070
    106 Local Institution - 0056 Merida Yucatan Mexico 97000
    107 Local Institution - 0053 Chihuahua Mexico 31210
    108 Local Institution - 0082 Bydgoszcz Kujawsko-pomorskie Poland 85-168
    109 Local Institution - 0177 Warszawa Mazowieckie Poland 02-665
    110 Local Institution - 0080 Elblag Poland 82-300
    111 Local Institution - 0079 Gdansk Poland 80-546
    112 Local Institution - 0081 Torun Poland 87-100
    113 Local Institution - 0112 Wrocław Poland 50-088
    114 Local Institution Ekaterinburg Russian Federation 620102
    115 Local Institution Kazan Russian Federation 420097
    116 Local Institution Moscow Russian Federation 107045
    117 Local Institution Moscow Russian Federation 121467
    118 Local Institution Novosibirsk Russian Federation 630047
    119 Local Institution Novosibirsk Russian Federation 630099
    120 Local Institution Saint Petersburg Russian Federation 194214
    121 Local Institution Saint-Petersburg Russian Federation 197022
    122 Local Institution Vladimir Russian Federation 600023
    123 Local Institution - 0014 Barcelona Spain 08035
    124 Local Institution Madrid Spain 28041
    125 Local Institution - 0045 Santander Spain 39008
    126 Local Institution Valencia Spain 46026
    127 Local Institution - 0090 Taichung City Taiwan 402
    128 Local Institution Taichung Taiwan 40447
    129 Local Institution Taichung Taiwan 40705
    130 Local Institution - 0091 Taipei Taiwan 10002
    131 Local Institution - 0087 Taipei Taiwan 11217
    132 Local Institution - 0060 Bradford United Kingdom BD5 0NA
    133 Local Institution Hull United Kingdom HU3 2JZ
    134 Local Institution Liverpool United Kingdom L9 7AL
    135 Local Institution - 0062 London United Kingdom E11 1NR
    136 Local Institution London United Kingdom SW17 0QT
    137 Local Institution Manchester United Kingdom M13 9WL

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT04908189
    Other Study ID Numbers:
    • IM011-055
    • 2020-005099-36
    • U1111-1259-9466
    First Posted:
    Jun 1, 2021
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 1, 2022
    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
    Apremilast
    BMS-986165

    Study Results

    No Results Posted as of Aug 1, 2022