A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)
NCT ID: NCT05306574
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
91 participants
INTERVENTIONAL
2022-06-20
2025-01-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Telitacicept
Telitacicept + Standard of Care (SoC)
Telitacicept
Subcutaneous injection weekly for 52 weeks
Placebo
Placebo + Standard of Care (SoC)
Placebo
Subcutaneous injection weekly for 52 weeks
Interventions
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Telitacicept
Subcutaneous injection weekly for 52 weeks
Placebo
Subcutaneous injection weekly for 52 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Active or unstable neuropsychiatric SLE.
3. Autoimmune or rheumatic disease other than SLE
12 Years
70 Years
ALL
No
Sponsors
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Vor Biopharma
INDUSTRY
Responsible Party
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Locations
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Anniston, Alabama Site
Anniston, Alabama, United States
Mission Hills Site
Mission Hills, California, United States
Orange Site
Orange, 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
Quilmes Site
Quilmes, Buenos Aires, Argentina
Rosario Site
Rosario, Santa Fe Province, Argentina
San Miguel de Tucuman Site 1
San Miguel de Tucumán, Tucumán Province, Argentina
San Miguel de Tucuman Site 2
San Miguel de Tucumán, Tucumán Province, Argentina
Ciudad Autonoma Buenos Aires Site 2
Ciudad Autonoma Buenos Aires, , Argentina
Cordoba Site
Córdoba, , Argentina
San Juan Site
San Juan, , Argentina
Garran Site
Garran, Austl. Cap. Terr., Australia
Murdoch Site
Murdoch, Western Australia, Australia
Pleven Site
Pleven, , Bulgaria
Plovdiv Site
Plovdiv, , Bulgaria
Ruse Site
Rousse, , 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
Barranquilla site
Barranquilla, , Colombia
Bucaramanga site
Bucaramanga, , Colombia
Medellin Site 1
Medellín, , Colombia
Medellin site 2
Medellín, , Colombia
Monteria site
Montería, , Colombia
Koeln Site
Cologne, North Rhine-Westphalia, Germany
Muenster Site
Münster, North Rhine-Westphalia, Germany
Guatemala site
Guatemala City, , Guatemala
Budapest Site
Budapest, , Hungary
Debrecen Site
Debrecen, , Hungary
Gyula Site
Gyula, , Hungary
Quatre Bornes Site
Quatre Bornes, , Mauritius
Cuernavaca Site
Cuernavaca, , Mexico
Guadalajara Site
Guadalajara, , Mexico
Ciudad de Mexico Site
Mexico City, , Mexico
Mexico site 1
México, , Mexico
Mexico Site 2
México, , Mexico
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
Poznan, , Poland
Szczecin Site
Szczecin, , Poland
Warszawa Site 2
Warsaw, , Poland
Warszawa Site 3
Warsaw, , Poland
Warszawa Site
Warsaw, , Poland
Wroclaw Site 2
Wroclaw, , Poland
Caguas Site
Caguas, , Puerto Rico
San Juan Site
San Juan, , Puerto Rico
Sevilla Site 1
Seville, , Spain
Sevilla Site 2
Seville, , Spain
Valencia Site
Valencia, , Spain
Countries
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Other Identifiers
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RC18G001
Identifier Type: -
Identifier Source: org_study_id
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