Clinical trial NCT06456567: A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
SLE
Lead sponsor: RemeGen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-13
Enrollment: 350
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: SLE Responder Index (SRI-4)
timeFrame: Week 52
Secondary outcomes:
measure: SLE Responder Index (SRI-4)
timeFrame: Week 24
measure: Achieve and sustain a low dose of corticosteriods
timeFrame: Week 52
measure: SLE Responder Index (SRI-4) and sustaining a low dose of corticosteriods
timeFrame: Week 52
measure: BILAG-based Combined Lupus Assessment (BICLA) Response
timeFrame: Week 52
measure: Time to Flare
timeFrame: Up to Week 52
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
timeFrame: Week 52
Other outcomes:
Locations:
city: Hemet
country: United States
facility: Hemet site
state: California
city: Menifee
country: United States
facility: Menifee site
state: California
city: Rockford
country: United States
facility: Rockford site
state: Illinois
city: Stafford
country: United States
facility: Stafford site
state: Texas
Study officials:
References: