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A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
490 patients around the world
Available in Argentina, Chile, Mexico, United States, Brazil, Peru, Spain
Bristol-Myers Squibb
41Research sites
490Patients around the world
This study is for people with
Lupus
Systemic lupus erythematosus
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- Diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks before the screening visitMeet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLEOne 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 screeningTotal 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 rashLupus 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 entryAt 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 participationOral 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
- Diagnosis of drug-induced SLE rather than idiopathic SLEOther 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 excludedActive or unstable lupus neuropsychiatric manifestations, including, but not limited to, any condition defined by BILAG A criteriaActive, severe Class III, and IV, lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CSHistory of congenital or acquired immunodeficiencyKnown 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
Sites
CER Instituto Médico - Quilmes, Buenos Aires
Recruiting
Fundación Sanatorio Güemes - CABA, Buenos Aires
Recruiting
Centro de Investigación Pergamino SA
Recruiting
Centro de Investigaciones Médicas Tucumán
Recruiting
Hospital Universitario Austral - Pilar
Recruiting
Centro Dermatológico Schejtman
Recruiting
Centro Integral de Reumatología - Tucumán
Recruiting
Hospital El Cruce - Nestor Kirchner
Recruiting
Hospital Italiano de La Plata
Recruiting
Centro Paulista de Investigação Clínica - CEPIC
Recruiting
StudyPOETYK SLE-2
SponsorBristol-Myers Squibb
Study typeInterventional
Conditions
Systemic lupus erythematosus
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05620407
