A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)
NCT05306574 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 91
Last updated 2026-01-09
Summary
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.
Conditions
Interventions
- BIOLOGICAL
-
Telitacicept
Subcutaneous injection weekly for 52 weeks
- BIOLOGICAL
-
Subcutaneous injection weekly for 52 weeks
Sponsors & Collaborators
-
Vor Biopharma
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-20
- Primary Completion
- 2025-01-06
- Completion
- 2025-01-06
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Bulgaria
- Chile
- Colombia
- Germany
- Guatemala
- Hungary
- Mauritius
- Mexico
- Philippines
- Poland
- Puerto Rico
- Spain
Study Locations
More Related Trials
-
A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
NCT02908100 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Telitacicept for Prevention of Flares in SLE Patients
NCT06394063 ·Status: RECRUITING ·Phase: NA
-
CD19-CART(Relma-cel) for Moderate to Severe Active Systemic Lupus Erythematosus
NCT05765006 ·Status: RECRUITING ·Phase: PHASE1
-
Effect of Telitacicept on Transitional Regulatory B Cells in Patients With Systemic Lupus Erythematosus
NCT06137053 ·Status: RECRUITING
-
Exploring the Therapeutic Effect of Telitacicept on Lupus Erythematosus Complicated With Thrombocytopenia
NCT05929248 ·Status: UNKNOWN ·Phase: PHASE2
-
Multi-omics Studies on the Efficacy of Telitacicept in Chinese SLE Patients
NCT05666336 ·Status: RECRUITING ·Phase: PHASE4
-
Efficacy and Immunological Evaluation of Telitacicept and Low Dose IL2 in the Treatment of Systemic Lupus Erythematosus
NCT05339217 ·Status: RECRUITING ·Phase: PHASE3
-
Relma-cel for Moderate to Severe Active Systemic Lupus Erythematosus
NCT06297408 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
A Study to Evaluate Safety and Tolerability of Subcutaneous Doses of MEDI-545 in Subjects With Lupus
NCT00657189 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE)
NCT03724916 ·Status: COMPLETED ·Phase: PHASE1
-
A Comparative Study of the Efficacy and Safety of Telitacicept and Belimumab in the Treatment of Systemic Lupus Erythematosus Involving Multiple Units, Based on Previous Data.
NCT07053137 ·Status: ACTIVE_NOT_RECRUITING
-
Safety and Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE)
NCT06458972 ·Status: RECRUITING
-
Rituximab Objective Outcome Measures Trial in SLE
NCT03054259 ·Status: UNKNOWN ·Phase: PHASE2
-
An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
NCT01753193 ·Status: COMPLETED ·Phase: PHASE2
-
A Prospective Comparative Study Involving Multiple Units to Evaluate the Efficacy and Safety of Telitacicept and Belimumab in the Treatment of Systemic Lupus Erythematosus.
NCT07069972 ·Status: NOT_YET_RECRUITING
-
GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia
NCT01345253 ·Status: COMPLETED ·Phase: PHASE3
-
ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)
NCT02955615 ·Status: COMPLETED ·Phase: PHASE2
-
Study of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE)
NCT03878303 ·Status: UNKNOWN ·Phase: PHASE1
-
A Study to Evaluate the Efficacy and Safety of Telitacicept in Subjects With Active Primary Sjogren's Syndrome
NCT05673993 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
NCT00137969 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
NCT01438489 ·Status: COMPLETED ·Phase: PHASE2
-
JMKX000189 for Moderate to Severe Active Systemic Lupus Erythematosus
NCT05967520 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus
NCT02725515 ·Status: COMPLETED ·Phase: PHASE2
-
An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
NCT03407482 ·Status: TERMINATED ·Phase: PHASE2
-
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