A Study of Obexelimab in Patients With Systemic Lupus Erythematosus

Part of paid clinical trials in Fresno, California.

Sponsor
Zenas BioPharma (USA), LLC
Study ID
NCT06559163
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Obexelimab — DRUG
    Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcyRllb, resulting in down regulation of B cell activity.
  • Placebo — DRUG
    Placebo

Study Details

This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus (SLE).

Key Dates

Start date
Sep 17, 2024
Status verified
May 2025
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
190 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Obexelimab
    Obexelimab will be administered as a subcutaneous injection for 24 weeks.
  • Placebo Comparator: Placebo
    Placebo will be administered as a subcutaneous injection for 24 weeks.

Primary Outcome Measure

Primary Outcome Measure [ Time Frame: 24 weeks ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Sierra Pacific Arthritis and Rheumatology CentersFresnoCalifornia93710-
California Research InstituteHuntington ParkCalifornia90255
Ramachandran Srinivasan
University of California, San DiegoLa JollaCalifornia92037
DoQuyen Huynh
Clinical Research of West Florida, IncClearwaterFlorida33765-
Clinical Research of West Florida, Inc.TampaFlorida33606-
Emory UniversityAtlantaGeorgia30322
Arezou Khosroshahi
Accurate Clinical ResearchLake CharlesLouisiana70605-
Henry Ford HospitalDetroitMichigan48202
Alireza Meysami
June DO, PCLansingMichigan48911-
Juno DO, PCLansingMichigan48911-
DJL Clinical Research PLLCCharlotteNorth Carolina28211-
Oklahoma Medical Research FoundationOklahoma CityOklahoma73104-5005
Christina Arriens
Penn State - Hershey Medical CenterHersheyPennsylvania17033
Nancy Olsen
Accurate Clinical ResearchHoustonTexas77089-
Prolato Clinical Research Center (PCRC)HoustonTexas77054-
Prime Clinical Research - MansfieldMansfieldTexas76063-

Find similar trials in Fresno, CA

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Sierra Pacific Arthritis and Rheumatology Centers· Fresno, CACalifornia Research Institute· Huntington Park, CAUniversity of California, San Diego· La Jolla, CAClinical Research of West Florida, Inc· Clearwater, FLClinical Research of West Florida, Inc.· Tampa, FLEmory University· Atlanta, GA

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