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

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Stage Trial to Evaluate Efficacy and Safety of Telitacicept Compared to Placebo in Patients With Moderately to Severely Active Systemic Lupus Erythematosus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05306574
• Other study ID #: RC18G001
• Status: Recruiting
• Phase: Phase 3
• Start date: June 20, 2022
• Est. completion date: September 21, 2025

Study information

• Verified date: November 2023
• Source: RemeGen Co., Ltd.
• Contact: RemeGen
• Phone: 301-284-1015
• 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, BCMA, and 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 operationally seamless study to evaluate the efficacy and safety of telitacicept 160 mg and 240 mg in a global patient population with active SLE disease. - Stage 1 - a dose ranging study to evaluate the efficacy, safety, pharmacokinetics (PK) and PD of telitacicept 160 mg and 240 mg in an international cohort of adult SLE patients. - Stage 2 - a confirmatory efficacy study to evaluate the telitacicept dose selected from Stage 1.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 341
• Est. completion date: September 21, 2025
• Est. primary completion date: June 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Has had a diagnosis of SLE for at least 6 months prior to the screening Visit.

2. Moderate to severely active SLE is defined by the following:

1. Hybrid SELENA SLEDAI (hSLEDAI) total score = 6 at screening with clinical hSLEDAI score = 4 points

2. BILAG-2004 organ system scores of at least 1 A or 2 B at screening.

3. Clinical hSLEDAI score of = 4 at Day 0 prior to randomization

4. At least one positive serologic parameter within the screening period

5. Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.

6. Other protocol defined inclusion criteria may apply.

Exclusion Criteria:

1. Active or unstable neuropsychiatric SLE or lupus nephritis

2. Autoimmune or rheumatic disease other than SLE

3. Significant, uncontrolled medical conditions not related to SLE

4. Active and/or severe viral, bacterial or fungal infection

5. History of malignancy within 5 years

6. Other protocol defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Telitacicept
subcutaneous injection weekly for 52 weeks
• Placebo
subcutaneous injection weekly for 52 weeks

Locations

Country	Name	City	State
Argentina	Ciudad Autonoma Buenos Aires Site 2	Ciudad Autonoma Buenos Aires
Argentina	Cordoba Site	Cordoba
Argentina	Quilmes Site	Quilmes	Buenos Aires
Argentina	Rosario Site	Rosario	Santa Fe
Argentina	San Juan Site	San Juan
Argentina	San Miguel de Tucuman Site 1	San Miguel de Tucuman	Tucuman
Argentina	San Miguel de Tucuman Site 2	San Miguel de Tucuman	Tucuman
Australia	Garran Site	Garran	Austl. Cap. Terr.
Australia	Murdoch Site	Murdoch	Western Australia
Bulgaria	Kardzhali Site	Kardzhali
Bulgaria	Pleven Site	Pleven
Bulgaria	Plovdiv Site	Plovdiv
Bulgaria	Ruse Site	Ruse
Bulgaria	Sevlievo Site	Sevlievo
Bulgaria	Sofia Site 1	Sofia
Bulgaria	Sofia Site 2	Sofia
Bulgaria	Sofia Site 3	Sofia
Bulgaria	Sofia Site 4	Sofia
Bulgaria	Sofia Site 5	Sofia
Bulgaria	Stara Zagora Site	Stara Zagora
Chile	Santiago Site 1	Santiago
Chile	Santiago Site 2	Santiago
Chile	Santiago Site 3	Santiago
Chile	Santiago Site 4	Santiago
Chile	Viña del Mar Site	Viña del Mar
Colombia	Barranquilla site	Barranquilla
Colombia	Barranquilla site	Barranquilla
Colombia	Bogotá site	Bogotá
Colombia	Bucaramanga site	Bucaramanga
Colombia	Medellin Site 1	Medellin
Colombia	Medellin site 2	Medellin
Colombia	Monteria site	Monteria
Germany	Koeln Site	Koeln	Nordrhein Westfalen
Germany	Muenster Site	Muenster	Nordrhein Westfalen
Hungary	Budapest Site	Budapest
Hungary	Debrecen Site	Debrecen
Hungary	Gyula Site	Gyula
Philippines	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
Poland	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	Krakow Site 2	Krakow
Poland	Lodz Site	Lodz
Poland	Lodz Site 2	Lodz
Poland	Malbork Site	Malbork
Poland	Poznan SIte	Poznan
Poland	Poznan Site	Poznan
Poland	Poznan Site 2	Poznan
Poland	Sosnowiec Site	Sosnowiec
Poland	Szczecin Site	Szczecin
Poland	Warszawa Site	Warszawa
Poland	Warszawa Site 2	Warszawa
Poland	Warszawa Site 3	Warszawa
Poland	Wroclaw Site	Wroclaw
Poland	Wroclaw Site 2	Wroclaw
Puerto Rico	Caguas Site	Caguas
Puerto Rico	San Juan Site	San Juan
Spain	Barcelona Site	Barcelona
Spain	Granada Site	Granada
Spain	Sevilla Site 1	Sevilla
Spain	Sevilla Site 2	Sevilla
Spain	Valencia Site	Valencia
United States	Anniston, Alabama Site	Anniston	Alabama
United States	Baytown Site	Baytown	Texas
United States	Birmingham, Alabama Site	Birmingham	Alabama
United States	Colleyville, Texas Site	Colleyville	Texas
United States	Debary, Florida Site	DeBary	Florida
United States	Eagan Site	Eagan	Minnesota
United States	Fort Lauderdale, FL Site	Fort Lauderdale	Florida
United States	Grand Blanc Site	Grand Blanc	Michigan
United States	Houston Site	Houston	Texas
United States	Huntington Park, California Site	Huntington Park	California
United States	La Mesa Site	La Mesa	California
United States	Miami, FL Site	Miami	Florida
United States	Mission Hills Site	Mission Hills	California
United States	Orlando Site	Orlando	Florida
United States	Rockford Site	Rockford	Illinois
United States	Salisbury Site	Salisbury	North Carolina
United States	Tampa, Florida Site	Tampa	Florida
United States	Thousands Oaks Site	Thousand Oaks	California
United States	Waco Site	Waco	Texas
United States	Wheaton, Maryland Site	Wheaton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
RemeGen Co., Ltd.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Bulgaria,  Chile,  Colombia,  Germany,  Hungary,  Philippines,  Poland,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Endpoint for Stage 1: SLE Responder Index (SRI-4)	Proportion of patients achieving a response in SRI-4	Week 24
Primary	Primary Endpoint for Stage 2: SLE Responder Index (SRI-4)	Proportion of patients achieving a response in SRI-4	Week 52
Secondary	Key secondary endpoint for Stage 2: BILAG-based Combined Lupus Assessment (BICLA)	Proportion of patients achieving a response in BICLA	Week 52
Secondary	Key secondary endpoint for Stage 2: achieve and sustain a low dose of corticosteroid	Proportion of patients who achieve or maintain prednisone	Weeks 40 - 52
Secondary	Key secondary endpoint for Stage 2: Annualized severe flare rate	Severe flare according to the SLEDAI Flare Index (SFI)	Week 52