A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05617677
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Deucravacitinib — DRUG
    Specified dose on specified days
  • Placebo — OTHER
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Jan 12, 2023
Status verified
Nov 2025
Primary completion
Oct 19, 2026
Completion
Nov 13, 2028

Study Design

Enrollment
516 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Deucravacitinib
  • Placebo Comparator: Arm 2: Placebo

Primary Outcome Measure

Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response [ Time Frame: At week 52 ]

Locations (48)

FacilityCityStateZIPSite coordinators
Local Institution - 0012BirminghamAlabama35205-
Local Institution - 0229PhoenixArizona85006-
Local Institution - 0193TucsonArizona85724-
Kaiser PermanenteFontanaCalifornia92335-
Local Institution - 0247La MesaCalifornia91942-
Local Institution - 0090La PalmaCalifornia90623-
Local Institution - 0124Los AngelesCalifornia90095-
Local Institution - 0248SacramentoCalifornia95817-
Local Institution - 0253San DiegoCalifornia92128-
Local Institution - 0128Santa BarbaraCalifornia93108-
Local Institution - 0099DenverColorado80230-
Local Institution - 0054New HavenConnecticut06510-
Local Institution - 0249Coral SpringsFlorida33065-
Local Institution - 0010GainesvilleFlorida32610-
Local Institution - 0087MiamiFlorida33136-
Local Institution - 0007OrlandoFlorida32806-
Local Institution - 0242PlantationFlorida33317-
Local Institution - 0002TamaracFlorida33321-
Local Institution - 0165TampaFlorida33614-
Local Institution - 0204AtlantaGeorgia30318-
Local Institution - 0147LawrencevilleGeorgia30046-
Local Institution - 0228LawrencevilleGeorgia30044-
Local Institution - 0227Morton GroveIllinois60053-
Local Institution - 0077SchaumburgIllinois60195-
Local Institution - 0108IndianapolisIndiana46202-
Lake Cumberland RheumatologyNew AlbanyIndiana47150-
Local Institution - 0225New OrleansLouisiana70121-
Local Institution - 0006DetroitMichigan48202-
Local Institution - 0179EaganMinnesota55121-
Local Institution - 0177SummitNew Jersey07901-
Local Institution - 0180ManhassetNew York11030-
Local Institution - 0085New YorkNew York10016-
Local Institution - 0098RochesterNew York14642-
Local Institution - 0159The BronxNew York10467-
Local Institution - 0155CharlotteNorth Carolina28211-
Local Institution - 0245CharlotteNorth Carolina28207-
Local Institution - 0246SummervilleSouth Carolina29486-
Local Institution - 0003MemphisTennessee38119-
Local Institution - 0064AllenTexas75013-
Local Institution - 0065DallasTexas75390-
Local Institution - 0088Fort WorthTexas76177-
Local Institution - 0250HoustonTexas77090-
Local Institution - 0219LubbockTexas79415-
Local Institution - 0005The WoodlandsTexas77382-
Local Institution - 0009RoanokeVirginia24016-
Local Institution - 0011SeattleWashington98122-
Local Institution - 0139SeattleWashington98195-
Local Institution - 0063FranklinWisconsin53132-

Find similar trials in Birmingham, AL

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Local Institution - 0012· Birmingham, ALLocal Institution - 0229· Phoenix, AZLocal Institution - 0193· Tucson, AZKaiser Permanente· Fontana, CALocal Institution - 0247· La Mesa, CALocal Institution - 0090· La Palma, CA

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