A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)
Part of paid clinical trials in Anniston, Alabama.
- Sponsor
- Vor Biopharma
- Study ID
- NCT05306574
- Phase
- PHASE3
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Telitacicept — BIOLOGICALSubcutaneous injection weekly for 52 weeks
- Placebo — BIOLOGICALSubcutaneous injection weekly for 52 weeks
Study Details
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.
Key Dates
- Start date
- Jun 20, 2022
- Status verified
- Jan 2026
- Primary completion
- Jan 6, 2025
- Completion
- Jan 6, 2025
Study Design
- Enrollment
- 91 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: TelitaciceptTelitacicept + Standard of Care (SoC)
- Placebo Comparator: PlaceboPlacebo + Standard of Care (SoC)
Primary Outcome Measure
SLE Responder Index (SRI-4) [ Time Frame: Week 52 ]
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Anniston, Alabama Site | Anniston | Alabama | 36207 | - |
| Mission Hills Site | Mission Hills | California | 91345 | - |
| Orange Site | Orange | California | 92868 | - |
| Thousands Oaks Site | Thousand Oaks | California | 91360 | - |
| Miami, FL Site | Miami | Florida | 33014 | - |
| Tampa, Florida Site | Tampa | Florida | 33765 | - |
| Wheaton, Maryland Site | Wheaton | Maryland | 20902 | - |
| Grand Blanc Site | Grand Blanc | Michigan | 48439 | - |
| Baytown Site | Baytown | Texas | 77521 | - |
| Colleyville, Texas Site | Colleyville | Texas | 76034 | - |
| Houston Site | Houston | Texas | 77084 | - |
| Waco Site | Waco | Texas | 76710 | - |
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