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 — BIOLOGICAL
    Subcutaneous injection weekly for 52 weeks
  • Placebo — BIOLOGICAL
    Subcutaneous 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: Telitacicept
    Telitacicept + Standard of Care (SoC)
  • Placebo Comparator: Placebo
    Placebo + Standard of Care (SoC)

Primary Outcome Measure

SLE Responder Index (SRI-4) [ Time Frame: Week 52 ]

Locations (12)

FacilityCityStateZIPSite coordinators
Anniston, Alabama SiteAnnistonAlabama36207-
Mission Hills SiteMission HillsCalifornia91345-
Orange SiteOrangeCalifornia92868-
Thousands Oaks SiteThousand OaksCalifornia91360-
Miami, FL SiteMiamiFlorida33014-
Tampa, Florida SiteTampaFlorida33765-
Wheaton, Maryland SiteWheatonMaryland20902-
Grand Blanc SiteGrand BlancMichigan48439-
Baytown SiteBaytownTexas77521-
Colleyville, Texas SiteColleyvilleTexas76034-
Houston SiteHoustonTexas77084-
Waco SiteWacoTexas76710-

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