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Purpose

The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1: Deucravacitinib
  • Drug: Deucravacitinib
    Specified dose on specified days
Placebo Comparator
Arm 2: Placebo
  • Other: Placebo
    Specified dose on specified days

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35205
Contact:
Jose Rubio, Site 0012

The University of Arizona Arthritis Center
Tucson, Arizona 85724
Contact:
Chian Kwoh, Site 0193
520-626-4111

Arthritis & Osteoporosis Medical Center - La Palma
La Palma, California 90623
Contact:
Gerald Ho, Site 0090
562-867-8195

UCLA Clinical & Translational Research Center (CTRC)
Los Angeles, California 90095
Contact:
Maureen McMahon, Site 0124
310-467-2380

Private Practice - Dr. Hans Richard Barthel
Santa Barbara, California 93108
Contact:
Hans Barthel, Site 0128
805-969-2560

Yale New Haven Hospital-Smilow Cancer Center
New Haven, Connecticut 06510
Contact:
Fotios Koumpouras, Site 0054
111-111-1111

University of Florida College of Medicine
Gainesville, Florida 32610
Contact:
Michael Bubb, Site 0010
352-682-6390

University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida 33136
Contact:
Maria Carpintero, Site 0087
305-243-8567

Omega Research Group - Orlando
Orlando, Florida 32806
Contact:
Kwabena Ayesu, Site 0007
386-668-4202

West Broward Rheumatology Associates
Tamarac, Florida 33321
Contact:
Elias Halpert, Site 0002
954-545-8401

Piedmont West
Atlanta, Georgia 30318
Contact:
Wambui Machua, Site 0204
404-367-3350

North Georgia Rheumatology
Lawrenceville, Georgia 30046
Contact:
Theresa Lawrence Ford, Site 0147
111-111-1111

IBJI Morton Grove
Morton Grove, Illinois 60053
Contact:
Alfonso Bello, Site 0227
847-724-4686

Greater Chicago Specialty Physicians
Schaumburg, Illinois 60195
Contact:
Kamran Chaudhary, Site 0077
847-599-2492

Ochsner Clinic Foundation
New Orleans, Louisiana 70121
Contact:
William Davis, Site 0225
504-842-3920

Saint Paul Rheumatology
Eagan, Minnesota 55121
Contact:
Elvia Moreta, Site 0179
651-361-8659

Atlantic Health System Overlook Medical Center
Summit, New Jersey 07901
Contact:
Neil Kramer, Site 0177
646-734-2774

The Feinstein Institute for Medical Research
Manhasset, New York 11030
Contact:
Meggan Mackay, Site 0180
516-562-3838

NYU Langone Health
New York, New York 10016
Contact:
Amit Saxena, Site 0085
646-501-7387

University of Rochester Medical Center
Rochester, New York 14642
Contact:
Ilana Abeles, Site 0098
585-273-2816

Carolinas HealthCare System SouthPark
Charlotte, North Carolina 28211
Contact:
Leslie Ranken, Site 0155
704-355-3162

Arthritis and Rheumatology Research Institute
Allen, Texas 75013
Contact:
Megha Patel-Banker, Site 0064
516-859-2951

UT Southwestern Medical Center
Dallas, Texas 75390
Contact:
David Karp, Site 0065
214-648-9110

Advanced Rheumatology of Houston - Woodlands
The Woodlands, Texas 77382
Contact:
Tamar Brionez, Site 0005
936-681-4882

Carilion Clinic
Roanoke, Virginia 24016
Contact:
Adegbenga Bankole, Site 0009
540-981-7700

Swedish Medical Center
Seattle, Washington 98122
Contact:
Philip Mease, Site 0011
206-386-2000

Centro Reumatologico Caguas
Caguas, Puerto Rico 00725
Contact:
AMARILIS PEREZ DE JESUS, Site 0203
7874471491

GCM Medical Group, PSC - Hato Rey Site
San Juan, Puerto Rico 00917
Contact:
Gregorio Cortes-Maisonet, Site 0197
787-936-2100

More Details

NCT ID
NCT05617677
Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

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