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

Phase 3

Not yet recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Placebo; Biological: Telitacicept

• Registration Number: NCT06456567
• Lead Sponsor: RemeGen Co., Ltd.

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-07
• Last Update Submitted: 2024-06-07
• Study First Posted: 2024-06-13
• Last Update Posted: 2024-06-13
• Study Start: 2024-07
• Primary Completion: 2027-03
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo + Standard of Care (SOC)
Telitacicept	Telitacicept	Telitacicept + Standard of Care (SOC)

Primary Outcome Measures

Name	Time	Method
SLE Responder Index (SRI-4)	Week 52	Proportion of subjects achieving an SLE Responder Index (SRI-4) response

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Hemet site; 🇺🇸 Hemet, California, United States

Menifee site; 🇺🇸 Menifee, California, United States

Rockford site; 🇺🇸 Rockford, Illinois, United States

Stafford site; 🇺🇸 Stafford, Texas, United States