A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (POETYK SLE-2)
Systemic Lupus Erythematosus
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Autoimmune Diseases, Immune System Diseases, Connective Tissue Diseases, Immune-mediated Diseases, Active Systemic Lupus Erythematosus, Lupus, SLE, Deucravacitinib, Tyk2, POETYK, POETYK SLE
Eligibility Criteria
Inclusion Criteria: Diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks before the screening visit Meet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE One of the following: positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR positive anti dsDNA OR positive anti Smith (anti Sm) as determined by the central laboratory at screening Total Systemic Lupus Erythematosus Disease Activity Index-2K (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI 2K score ≥ 4 points with joint involvement, and/or cutaneous vasculitis, and/or rash •Lupus headache, alopecia, organic brain syndrome, and mucosal ulcers must be recorded on SLEDAI 2K, if indicated, but do not count toward the points required for screening at entry At least one SLE background therapy(immunosuppressant and/or antimalarial) is required for ≥ 12 weeks before the screening visit, must be at a stable dose for ≥ 8 weeks before the screening visit, and must remain stable until randomization and throughout study participation Oral corticosteroid (OCS; prednisone or equivalent) background therapy is permitted but not required. For participants taking OCS, the dose must be stable for ≥ 2 weeks before the screening visit, cannot exceed 30 mg/day at screening, and must remain stable until the Week 4 visit. Participants can be on an OCS as well as an antimalarial and/or an immunosuppressant Exclusion Criteria: Diagnosis of drug-induced SLE rather than idiopathic SLE Other autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc.) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded -SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease are excluded Active or unstable lupus neuropsychiatric manifestations, including, but not limited to, any condition defined by BILAG A criteria Active, severe Class III, and IV, lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS History of congenital or acquired immunodeficiency Known active infection, or any major episode of infection requiring hospitalization or treatment with parenteral (intramuscular or IV) antimicrobial agents (eg, antibiotics antiviral, antifungal, or antiparasitic agents) within 30 days of randomization, or treatment with oral antimicrobial agents within 2 weeks of randomization -Currently on any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus, invasive bacterial or fungal infections, or atypical mycobacteria) Taking more than 1 immunosuppressant at screening In Japan only: Participants with positive result of β - D-glucan assay Other protocol-defined inclusion/exclusion criteria apply
Sites / Locations
- UCSD - Altman Clinical and Translational Research Institute (ACTRI)Recruiting
- UCSF Helen Diller Medical Center at Parnassus Heights
- East Bay Rheumatology Medical Group, Inc
- Providence Saint John's Medical Foundation
- UF Health Deerwood ParkRecruiting
- Life Clinical TrialsRecruiting
- Clinical Research Center of PompanoRecruiting
- Emory University School of Medicine- Grady CampusRecruiting
- Atlanta Research Center for RheumatologyRecruiting
- Greater Chicago Specialty Physicians - Orland ParkRecruiting
- Clinic of Robert Hozman, MD/Clinical Investigation Specialists, Inc.Recruiting
- The Center for Rheumatology and Bone Research
- Massachusetts General HospitalRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- University of Massachusetts Chan Medical SchoolRecruiting
- University of Michigan
- AA Medical Research Center-Grand BlancRecruiting
- Mayo Clinic in Rochester, Minnesota
- Saint Louis Rheumatology
- The Valley Hospital
- Joseph S. and Diane H. Steinberg Ambulatory Care CenterRecruiting
- Hospital for Special Surgery
- Columbia University Medical CenterRecruiting
- SUNY Upstate Medical University
- Javara - Tryon Medical Partners
- DJL Clinical Research, PLLC
- University of Cincinnati Medical Center
- University Hospitals Cleveland Medical CenterRecruiting
- Oklahoma Medical Research FoundationRecruiting
- Temple University Hospital
- Medical University of South CarolinaRecruiting
- West Tennessee Research InstituteRecruiting
- Austin Regional Clinic
- Precision Comprehensive Clinical Research Solutions - ColleyvilleRecruiting
- Metroplex Clinical Research Center
- Texas Arthritis CenterRecruiting
- Houston Rheumatology & Arthritis SpecialistsRecruiting
- Spectrum Medical, Inc.Recruiting
- Sound Clinical Research, LLCRecruiting
- Local Institution - 0146
- Local Institution - 0020
- Local Institution - 0078
- Local Institution - 0125
- Local Institution - 0136
- Local Institution - 0018
- Local Institution - 0013Recruiting
- Local Institution - 0027
- Local Institution - 0088
- Local Institution - 0141
- Local Institution - 0025
- Local Institution - 0179
- Local Institution - 0182
- Local Institution - 0066Recruiting
- Local Institution - 0177
- Local Institution - 0129Recruiting
- Local Institution - 0160
- Local Institution - 0033
- Local Institution - 0028
- Local Institution - 0154
- Local Institution - 0023
- Local Institution - 0175
- Local Institution - 0095
- Local Institution - 0115
- Local Institution - 0087
- Local Institution - 0161
- Local Institution - 0062
- Local Institution - 0158
- Local Institution - 0159
- Local Institution - 0163
- Local Institution - 0139Recruiting
- Local Institution - 0099
- Local Institution - 0101
- Local Institution - 0183
- Local Institution - 0044
- Local Institution - 0098
- Local Institution - 0140Recruiting
- Local Institution - 0153Recruiting
- Local Institution - 0174
- Local Institution - 0036Recruiting
- Local Institution - 0123
- Local Institution - 0116
- Local Institution - 0138
- Local Institution - 0057
- Local Institution - 0035
- Local Institution - 0134
- Local Institution - 0034
- Local Institution - 0053Recruiting
- Local Institution - 0156Recruiting
- Local Institution - 0083Recruiting
- Local Institution - 0086Recruiting
- Local Institution - 0117Recruiting
- Local Institution - 0082Recruiting
- Local Institution - 0048Recruiting
- Local Institution - 0162Recruiting
- Local Institution - 0111Recruiting
- Local Institution - 0157Recruiting
- Local Institution - 0021Recruiting
- Local Institution - 0113Recruiting
- Local Institution - 0022Recruiting
- Local Institution - 0171Recruiting
- Local Institution - 0046Recruiting
- Local Institution - 0173Recruiting
- Local Institution - 0049
- Local Institution - 0045Recruiting
- Local Institution - 0064Recruiting
- Local Institution - 0047Recruiting
- Local Institution - 0050Recruiting
- Local Institution - 0167Recruiting
- Local Institution - 0126Recruiting
- Local Institution - 0131Recruiting
- Local Institution - 0085Recruiting
- Local Institution - 0108Recruiting
- Local Institution - 0054Recruiting
- Local Institution - 0051Recruiting
- Local Institution - 0148Recruiting
- Local Institution - 0107
- Local Institution - 0015
- Local Institution - 0024
- Local Institution - 0011
- Local Institution - 0009
- Local Institution - 0077
- Local Institution - 0026
- Local Institution - 0010
- Local Institution - 0124
- Local Institution - 0096
- Local Institution - 0106
- Local Institution - 0074
- Local Institution - 0100
- Local Institution - 0176
- Local Institution - 0093
- Local Institution - 0121
- Local Institution - 0118
- Local Institution - 0186
- Local Institution - 0185
- Local Institution - 0119
- Local Institution - 0029
- Local Institution - 0016Recruiting
- Local Institution - 0017Recruiting
- Local Institution - 0071
- Local Institution - 0014Recruiting
- Local Institution - 0012
- Local Institution - 0031Recruiting
- Local Institution - 0019
- Local Institution - 0187
- Local Institution - 0068
- Local Institution - 0105
- Local Institution - 0109
- Local Institution - 0144
- Local Institution - 0073Recruiting
- Local Institution - 0135Recruiting
- Local Institution - 0127Recruiting
- Local Institution - 0151
- Local Institution - 0038Recruiting
- Local Institution - 0061Recruiting
- Local Institution - 0037
- Local Institution - 0103Recruiting
- Local Institution - 0110Recruiting
- Local Institution - 0055
- Local Institution - 0052Recruiting
- Local Institution - 0067Recruiting
- Local Institution - 0058Recruiting
- Local Institution - 0094
- Local Institution - 0040Recruiting
- Local Institution - 0065Recruiting
- Local Institution - 0114
- Local Institution - 0039Recruiting
- Local Institution - 0181
- Local Institution - 0122
- Local Institution - 0184
- Local Institution - 0166
- Local Institution - 0188
- Local Institution - 0170
- Local Institution - 0091
- Local Institution - 0090
- Local Institution - 0168
- Local Institution - 0104Recruiting
- Local Institution - 0092
- Local Institution - 0130
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm 1: Deucravacitinib
Arm 2: Placebo