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
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
RemeGen Co., Ltd. |
United States, Argentina, Australia, Bulgaria, Chile, Colombia, Germany, Hungary, Philippines, Poland, Puerto Rico, Spain,
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 = 7.5 mg/d or equivalent | 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 |
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