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

No results posted yet for this study

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

Placebo

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

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05306574 on ClinicalTrials.gov