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

NCT ID: NCT06456567

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-01-06

Brief Summary

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

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.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Telitacicept

Telitacicept + Standard of Care (SOC)

Group Type: EXPERIMENTAL

Telitacicept

Intervention Type: BIOLOGICAL

Subcutaneous injection

Placebo

Placebo + Standard of Care (SOC)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subcutaneous injection

Interventions

Telitacicept

Subcutaneous injection

Intervention Type: BIOLOGICAL

Placebo

Subcutaneous injection

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vor Biopharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hemet site

Hemet, California, United States

Menifee site

Menifee, California, United States

Rockford site

Rockford, Illinois, United States

Stafford site

Stafford, Texas, United States

Countries

United States

Other Identifiers

RC18G002

Identifier Type: -

Identifier Source: org_study_id