A Study of Obexelimab in Patients With Systemic Lupus Erythematosus
NCT06559163 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 190
Last updated 2025-07-30
Summary
This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus (SLE).
Conditions
Interventions
- DRUG
-
Obexelimab
Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcyRllb, resulting in down regulation of B cell activity.
- DRUG
-
Placebo
Sponsors & Collaborators
-
Zenas BioPharma (USA), LLC
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-17
- Primary Completion
- 2026-06-30
- Completion
- 2026-09-30
- FDA Drug
- Yes
Countries
- United States
- Belgium
- Bulgaria
- Canada
- China
- Denmark
- Germany
- Greece
- Italy
- Japan
- Mexico
- Poland
- Portugal
- Puerto Rico
- Romania
- South Africa
- Spain
- Taiwan
Study Locations
More Related Trials
-
A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus
NCT03161483 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
NCT02446899 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
NCT02446912 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus
NCT02725515 ·Status: COMPLETED ·Phase: PHASE2
-
Study of CM313(SC) Injection in Systemic Lupus Erythematosus(SLE)
NCT06791772 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)
NCT02955615 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus
NCT02265744 ·Status: COMPLETED ·Phase: PHASE2
-
Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus
NCT02794285 ·Status: COMPLETED ·Phase: PHASE3
-
A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus
NCT05123586 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus
NCT01283139 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
NCT00962832 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis
NCT02547922 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study
NCT05430854 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus
NCT00410384 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
NCT04895241 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Evaluation of Belimumab Impact on a BLyS Activity Signature Test in the Absence of Confounding Polypharmacy
NCT02270970 ·Status: UNKNOWN ·Phase: PHASE4
-
A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
NCT05531565 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
An Extension Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
NCT05352919 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE3
-
A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
NCT04961567 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus
NCT05465707 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Belimumab Assessment of Safety in SLE
NCT01705977 ·Status: COMPLETED ·Phase: PHASE4
-
A Clinical Trial to Evaluate Safety of Gusacitinib in Patients With Systemic Lupus Erythematosus (SLE) or Lupus
NCT06238531 ·Status: WITHDRAWN ·Phase: PHASE1
-
A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE Participants
NCT06625671 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
NCT03943147 ·Status: TERMINATED ·Phase: PHASE2
-
A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
NCT03845517 ·Status: COMPLETED ·Phase: PHASE2