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

RECRUITING

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

Conditions:

Systemic Lupus Erythematosus

Study Start (Actual) 2022-06-20

Primary Completion (Estimated) 2025-06-29

Study Completion (Estimated) 2025-09-21

Enrollment (Estimated) 341

Study Type INTERVENTIONAL

Phase PHASE3

Locations:

📍 Anniston, Alabama, United States

📍 Birmingham, Alabama, United States

📍 Huntington Park, California, United States

📍 La Mesa, California, United States

📍 Mission Hills, California, United States

📍 Thousand Oaks, California, United States

📍 DeBary, Florida, United States

📍 Fort Lauderdale, Florida, United States

📍 Miami, Florida, United States

📍 Orlando, Florida, United States

📍 Tampa, Florida, United States

📍 Rockford, Illinois, United States

📍 Wheaton, Maryland, United States

📍 Grand Blanc, Michigan, United States

📍 Eagan, Minnesota, United States

📍 Salisbury, North Carolina, United States

📍 Baytown, Texas, United States

📍 Colleyville, Texas, United States

📍 Houston, Texas, United States

📍 Waco, Texas, United States

📍 Quilmes, Buenos Aires, Argentina

📍 Rosario, Santa Fe, Argentina

📍 San Miguel de Tucuman, Tucuman, Argentina

📍 Ciudad Autonoma Buenos Aires, Argentina

📍 Cordoba, Argentina

📍 San Juan, Argentina

📍 Garran, Austl. Cap. Terr., Australia

📍 Murdoch, Western Australia, Australia

📍 Kardzhali, Bulgaria

📍 Pleven, Bulgaria

📍 Plovdiv, Bulgaria

📍 Ruse, Bulgaria

📍 Sevlievo, Bulgaria

📍 Sofia, Bulgaria

📍 Stara Zagora, Bulgaria

📍 Santiago, Chile

📍 Viña del Mar, Chile

📍 Barranquilla, Colombia

📍 Bogotá, Colombia

📍 Bucaramanga, Colombia

📍 Medellin, Colombia

📍 Monteria, Colombia

📍 Koeln, Nordrhein Westfalen, Germany

📍 Muenster, Nordrhein Westfalen, Germany

📍 Budapest, Hungary

📍 Debrecen, Hungary

📍 Gyula, Hungary

📍 Batangas, Philippines

📍 Cagayan De Oro, Philippines

📍 Los Baños, Philippines

📍 Makati City, Philippines

📍 Manila, Philippines

📍 Bydgoszcz, Poland

📍 Bytom, Poland

📍 Katowice, Poland

📍 Krakow, Poland

📍 Lodz, Poland

📍 Malbork, Poland

📍 Poznan, Poland

📍 Poznań, Poland

📍 Sosnowiec, Poland

📍 Szczecin, Poland

📍 Warszawa, Poland

📍 Wroclaw, Poland

📍 Caguas, Puerto Rico

📍 San Juan, Puerto Rico

📍 Barcelona, Spain

📍 Granada, Spain

📍 Sevilla, Spain

📍 Valencia, Spain

More locations available...

Eligibility Criteria

Description

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.

Ages Eligible for Study: 12 Years to 70 Years (CHILD, ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2022-03-23
First Submitted that Met QC Criteria2022-03-23
First Posted2022-04-01

Study Record Updates

Last Update Submitted that Met QC Criteria2023-11-16
Last Update Posted2023-11-18
Last Verified2023-11