A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Telitacicept Compared to Placebo in Patients With Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2)

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.

Study Overview

• Status: Withdrawn
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: Placebo; Biological: Telitacicept

Detailed Description

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease with heterogeneous manifestations and disease course. Despite advances in medical care, there are still significant unmet needs in SLE with diminished health-related quality of life (HRQoL), persistent disease activity, disease flares, intolerance to standard of care (SOC) therapies, and development of organ damage and co-morbidities.

Telitacicept is a fully human TACI-Fc fusion protein that targets B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL). Blocking the interaction of BLyS and APRIL with their cell membrane receptors (TACI, B-cell maturation antigen (BCMA), and B-cell activating factor receptor (BAFF-R) would inhibit B cell proliferation and maturation, suppresses immune responses and may alleviate autoimmune symptoms.

This is a multicenter, randomized, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of telitacicept added to standard of care (SoC) therapy compared to placebo with SoC therapy in subjects with moderately to severely active SLE.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Hemet, California, United States, 92543
      • Hemet site
    • Menifee, California, United States, 92586
      • Menifee site
  • Illinois
    • Rockford, Illinois, United States, 61114
      • Rockford site
  • Texas
    • Stafford, Texas, United States, 77477
      • Stafford site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 12-70 years at screening.
2. Has a diagnosis of SLE for at least 6 months prior to the screening visit.
3. Meets the 2019 EULAR/ACR Classification criteria for SLE.

4. Moderately to severely active SLE definined by the following:

   1. SELENA SLEDAI total score ≥6 points with clinical SLEDAI score ≥4 points at screening;
   2. BILAG organ system scores of at least 1A or 2B at screening.
5. Clinical SLEDAI score of ≥4 at Day 0 prior to randomization.
6. At least one positive serologic parameter within the screening period.
7. Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.

Exclusion Criteria:

1. Active lupus nephritis undergoing induction therapy or unstable renal diseases within 12 weeks prior to screening.
2. Active or unstable neuropsychiatric SLE.
3. Autoimmune or rheumatic disease other than SLE.
4. History of arterial or venous thromboembolism or microangiopathy within 12 months prior to screening.
5. History of non-SLE disease requiring treatment with oral or parenteral. glucocorticosteroids for more than a total of 2 weeks within the last 24 weeks prior to screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telitacicept; Telitacicept + Standard of Care (SOC)	Biological: Telitacicept; Subcutaneous injection
Placebo Comparator: Placebo; Placebo + Standard of Care (SOC)	Drug: Placebo; Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SLE Responder Index (SRI-4)	Proportion of subjects achieving an SLE Responder Index (SRI-4) response	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SLE Responder Index (SRI-4)	Proportion of subjects achieving an SLE Responder Index (SRI-4) response	Week 24
Achieve and sustain a low dose of corticosteriods	Proportion of subjects achieving the target of corticosteroids reduction.	Week 52
SLE Responder Index (SRI-4) and sustaining a low dose of corticosteriods	Proportion of patients achieving an SRI-4 response at Week 52, while achieving and maintaining corticosteroids reduction.	Week 52
BILAG-based Combined Lupus Assessment (BICLA) Response	Proportion of patients achieving a BILAG-based Combined Lupus Assessment (BICLA) response at Week 52	Week 52
Time to Flare	Time to flare assessed by SELENA-SLEDAI Flare Index (SFI) from baseline through Week 52	Up to Week 52
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)	Proportion of patients achieving clinically meaningful improvement in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52	Week 52

Collaborators and Investigators

• Sponsor: Vor Biopharma

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Actual): January 2, 2025
• Study Completion (Actual): January 6, 2025

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: SLE; Systemic Lupus Erythematosus
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; telitacicept
• Other Study ID Numbers: RC18G002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No