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

NCT06456567 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: RC18G002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

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.

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus; SLE

Outcome Measures

Primary Outcomes (1)

• SLE Responder Index (SRI-4)

  Proportion of subjects achieving an SLE Responder Index (SRI-4) response

  Week 52

Secondary Outcomes (6)

• SLE Responder Index (SRI-4)

  Week 24

• Achieve and sustain a low dose of corticosteriods

  Week 52

• SLE Responder Index (SRI-4) and sustaining a low dose of corticosteriods

  Week 52

• BILAG-based Combined Lupus Assessment (BICLA) Response

  Week 52

• Time to Flare

  Up to Week 52

Study Arms (2)

Telitacicept

EXPERIMENTAL

Telitacicept + Standard of Care (SOC)

Biological: Telitacicept

Placebo

PLACEBO COMPARATOR

Placebo + Standard of Care (SOC)

Drug: Placebo

Interventions

Telitacicept BIOLOGICAL

Subcutaneous injection

Telitacicept

Placebo DRUG

Subcutaneous injection

Placebo

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 12-70 years at screening.
• Has a diagnosis of SLE for at least 6 months prior to the screening visit.
• Meets the 2019 EULAR/ACR Classification criteria for SLE.
• Moderately to severely active SLE definined by the following:
• SELENA SLEDAI total score ≥6 points with clinical SLEDAI score ≥4 points at screening;
• BILAG organ system scores of at least 1A or 2B at screening.
• Clinical SLEDAI score of ≥4 at Day 0 prior to randomization.
• At least one positive serologic parameter within the screening period.
• Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.

You may not qualify if:

• Active lupus nephritis undergoing induction therapy or unstable renal diseases within 12 weeks prior to screening.
• Active or unstable neuropsychiatric SLE.
• Autoimmune or rheumatic disease other than SLE.
• History of arterial or venous thromboembolism or microangiopathy within 12 months prior to screening.
• 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.

Sponsors & Collaborators

• Vor Biopharma: lead

Study Sites (4)

Hemet site

Hemet, California, 92543, United States

Location

Menifee site

Menifee, California, 92586, United States

Location

Rockford site

Rockford, Illinois, 61114, United States

Location

Stafford site

Stafford, Texas, 77477, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

telitacicept

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 13, 2024
• Study Start: September 1, 2024
• Primary Completion: January 2, 2025
• Study Completion: January 6, 2025
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)