A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus

Part of paid clinical trials in Los Alamitos, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04882878
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — OTHER
    Placebo will be administered intravenously.
  • Nipocalimab — DRUG
    Nipocalimab dose 1 and dose 2 will be administered intravenously.
  • Standard-of-care treatment — DRUG
    Standard-of-care treatment including immunomodulators, antimalarial drugs and GCs will be administered orally.

Study Details

The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active systemic lupus erythematosus (SLE).

Key Dates

Start date
Aug 20, 2021
Status verified
Dec 2025
Primary completion
Apr 30, 2024
Completion
Dec 26, 2024

Study Design

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

Arms

  • Placebo Comparator: Group 1: Placebo
    Participants will receive placebo intravenously (IV) every two weeks (q2w) through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and Glucocorticoids \[GCs\]).
  • Experimental: Group 2: Nipocalimab Dose 1
    Participants will receive nipocalimab dose 1 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs).
  • Experimental: Group 3: Nipocalimab Dose 2
    Participants will receive nipocalimab dose 2 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs).

Primary Outcome Measure

Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 24 [ Time Frame: Week 24 ]

Locations (21)

FacilityCityStateZIPSite coordinators
Valerius Medical Group & Research CenterLos AlamitosCalifornia90720-
Desert Medical AdvancesRancho MirageCalifornia92270-
Wolverine Clinical TrialsSanta AnaCalifornia92705-
Millennium Clinical Trials LLCWestlake VillageCalifornia91361-
Bay Area Arthritis and OsteoporosisBrandonFlorida33511-
GNP ResearchCooper CityFlorida33024-
South Coast Research CenterMiamiFlorida33136-
Advanced Clinical Research of OrlandoOcoeeFlorida34761-
Omega Research ConsultantsOrlandoFlorida32808-
Millennium ResearchOrmond BeachFlorida32174-
North Georgia Rheumatology, PCLawrencevilleGeorgia30046-
Atlanta Research Center for RheumatologyMariettaGeorgia30060-
West County RheumatologySt LouisMissouri63131-
DJL Clinical Research, PLLCCharlotteNorth Carolina28210-
Paramount Medical Research & ConsultingMiddleburg HeightsOhio44130-
Dr. Ramesh GuptaMemphisTennessee38119-
Arthritis and Rheumatology Research InstituteAllenTexas75013-
Precision Comprehensive Clinical Research SolutionsColleyvilleTexas76034-
Southwest Rheumatology Research LLCMesquiteTexas75150-
Epic Medical ResearchRed OakTexas75154-
Rheumatology and Pulmonary ClinicBeckleyWest Virginia25801-

Find similar trials in Los Alamitos, CA

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Valerius Medical Group & Research Center· Los Alamitos, CADesert Medical Advances· Rancho Mirage, CAWolverine Clinical Trials· Santa Ana, CAMillennium Clinical Trials LLC· Westlake Village, CABay Area Arthritis and Osteoporosis· Brandon, FLGNP Research· Cooper City, FL

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