A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)

Phase 3

Active, not recruiting

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

• Registration Number: NCT05306574
• 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 Phase 3 study is a 2-stage study to evaluate the efficacy and safety of telitacicept compared to placebo in patients with moderately to severely active SLE while receiving SoC treatment in a global patient population with active SLE disease.

* Stage 1: a study to evaluate the efficacy, safety, pharmacokinetics (PK) and PD of two treatment arms of telitacicept compared to placebo in patients with moderately to severely active SLE while receiving SoC treatment.

* Stage 2: a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of telitacicept added to SoC compared to placebo with SoC therapy in patients with moderately to severely active SLE.

Study Timeline

• Study First Submitted: 2022-03-23
• Study First Submitted QC: 2022-03-23
• Study First Posted: 2022-04-01
• Study Start: 2022-06-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19
• Primary Completion: 2027-01-02
• Study Completion: 2027-03-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_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 defined 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telitacicept	Telitacicept	Telitacicept + Standard of Care (SoC)
Placebo	Placebo	Placebo + 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 at Week 52

Secondary Outcome Measures

Name	Time	Method
SLE Responder Index (SRI-4)	Week 24	Proportion of subjects achieving an SLE Responder Index (SRI-4) response at Week 24
Achieve and sustain a low dose of corticosteriods	Weeks 52	Proportion of subjects achieving the target of corticosteroids reduction through Week 52.
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
Time to Flare	Week 52	Time to flare assessed by SELENA-SLEDAI Flare Index (SFI) from baseline through 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

Trial Locations

Locations (76)

Guatemala site; 🇬🇹 Guatemala, Guatemala

Orange Site; 🇺🇸 Orange, California, United States

Quatre Bornes Site; 🇲🇺 Quatre Bornes, Mauritius

Ciudad de Mexico Site; 🇲🇽 Ciudad de Mexico, Mexico

Cuernavaca Site; 🇲🇽 Cuernavaca, Mexico

Guadalajara Site; 🇲🇽 Guadalajara, Mexico

Mexico site 1; 🇲🇽 Mexico, Mexico

Mexico Site 2; 🇲🇽 Mexico, Mexico

Anniston, Alabama Site; 🇺🇸 Anniston, Alabama, United States

Mission Hills Site; 🇺🇸 Mission Hills, California, United States

Thousands Oaks Site; 🇺🇸 Thousand Oaks, California, United States

Miami, FL Site; 🇺🇸 Miami, Florida, United States

Tampa, Florida Site; 🇺🇸 Tampa, Florida, United States

Wheaton, Maryland Site; 🇺🇸 Wheaton, Maryland, United States

Grand Blanc Site; 🇺🇸 Grand Blanc, Michigan, United States

Baytown Site; 🇺🇸 Baytown, Texas, United States

Colleyville, Texas Site; 🇺🇸 Colleyville, Texas, United States

Houston Site; 🇺🇸 Houston, Texas, United States

Waco Site; 🇺🇸 Waco, Texas, United States

Medellin Site 1; 🇨🇴 Medellin, Colombia

Quilmes Site; 🇦🇷 Quilmes, Buenos Aires, Argentina

Rosario Site; 🇦🇷 Rosario, Santa Fe, Argentina

San Miguel de Tucuman Site 1; 🇦🇷 San Miguel de Tucuman, Tucuman, Argentina

San Miguel de Tucuman Site 2; 🇦🇷 San Miguel de Tucuman, Tucuman, Argentina

Ciudad Autonoma Buenos Aires Site 2; 🇦🇷 Ciudad Autonoma Buenos Aires, Argentina

Cordoba Site; 🇦🇷 Cordoba, Argentina

San Juan Site; 🇵🇷 San Juan, Puerto Rico

Garran Site; 🇦🇺 Garran, Austl. Cap. Terr., Australia

Murdoch Site; 🇦🇺 Murdoch, Western Australia, Australia

Pleven Site; 🇧🇬 Pleven, Bulgaria

Plovdiv Site; 🇧🇬 Plovdiv, Bulgaria

Ruse Site; 🇧🇬 Ruse, Bulgaria

Sevlievo Site; 🇧🇬 Sevlievo, Bulgaria

Sofia Site 1; 🇧🇬 Sofia, Bulgaria

Sofia Site 4; 🇧🇬 Sofia, Bulgaria

Sofia Site 5; 🇧🇬 Sofia, Bulgaria

Sofia Site 3; 🇧🇬 Sofia, Bulgaria

Stara Zagora Site; 🇧🇬 Stara Zagora, Bulgaria

Santiago Site 4; 🇨🇱 Santiago, Chile

Santiago Site 1; 🇨🇱 Santiago, Chile

Santiago Site 3; 🇨🇱 Santiago, Chile

Santiago Site 2; 🇨🇱 Santiago, Chile

Barranquilla site; 🇨🇴 Barranquilla, Colombia

Bucaramanga site; 🇨🇴 Bucaramanga, Colombia

Medellin site 2; 🇨🇴 Medellin, Colombia

Monteria site; 🇨🇴 Monteria, Colombia

Koeln Site; 🇩🇪 Koeln, Nordrhein Westfalen, Germany

Muenster Site; 🇩🇪 Muenster, Nordrhein Westfalen, Germany

Budapest Site; 🇭🇺 Budapest, Hungary

Debrecen Site; 🇭🇺 Debrecen, Hungary

Gyula Site; 🇭🇺 Gyula, Hungary

Batangas Site; 🇵🇭 Batangas, Philippines

Cagayan de Oro City Site; 🇵🇭 Cagayan De Oro, Philippines

Los Baños Site; 🇵🇭 Los Baños, Philippines

Makati City Site; 🇵🇭 Makati City, Philippines

Manila Site; 🇵🇭 Manila, Philippines

Bydgoszcz Site; 🇵🇱 Bydgoszcz, Poland

Bydgoszcz Site 2; 🇵🇱 Bydgoszcz, Poland

Bydgoszcz Site 3; 🇵🇱 Bydgoszcz, Poland

Bytom Site; 🇵🇱 Bytom, Poland

Katowice Site; 🇵🇱 Katowice, Poland

Krakow Site 1; 🇵🇱 Krakow, Poland

Lodz Site; 🇵🇱 Lodz, Poland

Malbork Site; 🇵🇱 Malbork, Poland

Poznan Site 2; 🇵🇱 Poznan, Poland

Poznan SIte; 🇵🇱 Poznan, Poland

Poznań Site; 🇵🇱 Poznań, Poland

Szczecin Site; 🇵🇱 Szczecin, Poland

Warszawa Site 2; 🇵🇱 Warszawa, Poland

Warszawa Site 3; 🇵🇱 Warszawa, Poland

Warszawa Site; 🇵🇱 Warszawa, Poland

Wroclaw Site 2; 🇵🇱 Wroclaw, Poland

Caguas Site; 🇵🇷 Caguas, Puerto Rico

Sevilla Site 1; 🇪🇸 Sevilla, Spain

Sevilla Site 2; 🇪🇸 Sevilla, Spain

Valencia Site; 🇪🇸 Valencia, Spain