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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06456567
• Other study ID #: RC18G002
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 2024
• Est. completion date: April 2027

Study information

• Verified date: June 2024
• Source: RemeGen Co., Ltd.
• Contact: RemeGen
• Phone: 800-910-6542
• Email: RC18_SLEstudy[@]remegenbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: April 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• Telitacicept
Subcutaneous injection

Drug:
• Placebo
Subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RemeGen Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SLE Responder Index (SRI-4)	Proportion of subjects achieving an SLE Responder Index (SRI-4) response	Week 52
Secondary	SLE Responder Index (SRI-4)	Proportion of subjects achieving an SLE Responder Index (SRI-4) response	Week 24
Secondary	Achieve and sustain a low dose of corticosteriods	Proportion of subjects achieving the target of corticosteroids reduction.	Week 52
Secondary	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
Secondary	BILAG-based Combined Lupus Assessment (BICLA) Response	Proportion of patients achieving a BILAG-based Combined Lupus Assessment (BICLA) response at Week 52	Week 52
Secondary	Time to Flare	Time to flare assessed by SELENA-SLEDAI Flare Index (SFI) from baseline through Week 52	Up to Week 52
Secondary	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