A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-1)
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 Other protocol-defined inclusion/exclusion criteria apply
Sites / Locations
- Pinnacle Research Group, LLC
- University of Alabama at BirminghamRecruiting
- The University of Arizona Arthritis Center
- Kaiser Permanente
- Private Practice - Dr. Chandrakant V. Mehta
- Arthritis & Osteoporosis Medical Center - La PalmaRecruiting
- UCLA Clinical & Translational Research Center (CTRC)
- Private Practice - Dr. Hans Richard BarthelRecruiting
- Denver Arthritis ClinicRecruiting
- Yale University School of MedicineRecruiting
- Rheumatology Assoc. Of South Florida
- Nouvelle Clinical Research
- University of Florida College of MedicineRecruiting
- University of Miami Hospital and Clinics, Sylvester Cancer Center
- Omega Research Group - OrlandoRecruiting
- West Broward Rheumatology AssociatesRecruiting
- Genesis Clinical Research, LLC
- Baycare Medical Group
- North Georgia Rheumatology
- Greater Chicago Specialty PhysiciansRecruiting
- Indiana University Health University HospitalRecruiting
- Lake Cumberland Rheumatology
- University of Maryland
- Henry Ford HospitalRecruiting
- Saint Paul Rheumatology
- Atlantic Health System Overlook Medical CenterRecruiting
- Montefiore Medical CenterRecruiting
- The Feinstein Institute for Medical Research
- NYU Langone HealthRecruiting
- University of Rochester Medical CenterRecruiting
- Carolinas HealthCare System SouthParkRecruiting
- STAT Research
- Shelby Research LLCRecruiting
- Arthritis & Rheumatology Research InstituteRecruiting
- UT Southwestern Medical CenterRecruiting
- Dallas Fort Worth Clinical Research Associates - North Tarrant ParkwayRecruiting
- Advanced Rheumatology of Houston - WoodlandsRecruiting
- Carilion ClinicRecruiting
- Swedish Medical CenterRecruiting
- University of Washington Medical Center - MontlakeRecruiting
- Aurora Rheumatology
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- Nouvel Hôpital Civil (NHC)Recruiting
- Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-DieuRecruiting
- Hôpitaux Universitaires Paris Sud - Hôpital BicêtreRecruiting
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- GCM Medical Group, PSC - Hato Rey Site
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Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm 1: Deucravacitinib
Arm 2: Placebo