A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus

Part of paid clinical trials in La Jolla, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05620407
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
513 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 (39)

FacilityCityStateZIPSite coordinators
Local Institution - 0063La JollaCalifornia92037-
Local Institution - 0241La MesaCalifornia91942-
Local Institution - 0242San DiegoCalifornia92128-
Local Institution - 0143San LeandroCalifornia94578-
Local Institution - 0147Santa MonicaCalifornia90404-
Local Institution - 0213ClearwaterFlorida33765-
Local Institution - 0059JacksonvilleFlorida32256-
Local Institution - 0075MargateFlorida33063-
Local Institution - 0007Oakland ParkFlorida33334-
Local Institution - 0239Plant CityFlorida33160-
Emory University School of Medicine- Grady CampusAtlantaGeorgia30303-
Local Institution - 0137MariettaGeorgia30060-
Local Institution - 0089Orland ParkIllinois60467-
Local Institution - 0041SkokieIllinois60076-
Local Institution - 0231New OrleansLouisiana70112-
Local Institution - 0056BostonMassachusetts02215-
Local Institution - 0060BostonMassachusetts02114-
Local Institution - 0084WorcesterMassachusetts01605-
Local Institution - 0152Grand BlancMichigan48439-
Local Institution - 0072RochesterMinnesota55905-
Local Institution - 0216Las VegasNevada89102-
Local Institution - 0165ParamusNew Jersey07652-
Local Institution - 0069BrooklynNew York11201-
Local Institution - 0217Great NeckNew York11021-
Local Institution - 0102New YorkNew York10032-
Local Institution - 0150New YorkNew York10021-
Local Institution - 0145SyracuseNew York13210-
Local Institution - 0178CharlotteNorth Carolina28210-
Local Institution - 0005ClevelandOhio44106-
Local Institution - 0043Oklahoma CityOklahoma73104-
Local Institution - 0205PittsburghPennsylvania15224-
Local Institution - 0081CharlestonSouth Carolina29425-
Local Institution - 0225FlorenceSouth Carolina29501-
Local Institution - 0002JacksonTennessee38305-
Local Institution - 0001ColleyvilleTexas76034-
Local Institution - 0164El PasoTexas79902-
Local Institution - 0169KatyTexas77494-
Local Institution - 0201TempleTexas76508-
Local Institution - 0133DanvilleVirginia24541-

Find similar trials in La Jolla, CA

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Local Institution - 0063· La Jolla, CALocal Institution - 0241· La Mesa, CALocal Institution - 0242· San Diego, CALocal Institution - 0143· San Leandro, CALocal Institution - 0147· Santa Monica, CALocal Institution - 0213· Clearwater, FL

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