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

NCT05306574 | Terminated Phase 3 FDA Drug

• 1 other identifier: RC18G001
• Study Type: interventional
• Target: 91
• Locations: 15 countries
• Sites: 78

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.

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus; SLE

Outcome Measures

Primary Outcomes (1)

• SLE Responder Index (SRI-4)

  Proportion of subjects achieving an SLE Responder Index (SRI-4) response at Week 52

  Week 52

Secondary Outcomes (6)

• SLE Responder Index (SRI-4)

  Week 24

• Achieve and sustain a low dose of corticosteriods

  Weeks 52

• SLE Responder Index (SRI-4) and sustaining a low dose of corticosteriods

  Week 52

• BILAG-based Combined Lupus Assessment (BICLA) Response

  Week 52

• Time to Flare

  Week 52

Study Arms (2)

Telitacicept

EXPERIMENTAL

Telitacicept + Standard of Care (SoC)

Biological: Telitacicept

Placebo

PLACEBO COMPARATOR

Placebo + Standard of Care (SoC)

Biological: Placebo

Interventions

Telitacicept BIOLOGICAL

Subcutaneous injection weekly for 52 weeks

Also known as: RC18, RC18-L

Telitacicept

Placebo BIOLOGICAL

Subcutaneous injection weekly for 52 weeks

Placebo

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 12-70 years at screening.
• Has a diagnosis of SLE for at least 6 months prior to the screening visit.
• Meets the 2019 EULAR/ACR Classification criteria for SLE.
• Moderately to severely active SLE defined by the following:
• SELENA SLEDAI total score ≥6 points with clinical SLEDAI score ≥4 points at screening;
• BILAG organ system scores of at least 1A or 2B at screening.
• Clinical SLEDAI score of ≥4 at Day 0 prior to randomization.
• At least one positive serologic parameter within the screening period.
• Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.

You may not qualify if:

• Active lupus nephritis undergoing induction therapy or unstable renal diseases within 12 weeks prior to screening.
• Active or unstable neuropsychiatric SLE.
• Autoimmune or rheumatic disease other than SLE

Sponsors & Collaborators

• Vor Biopharma: lead

Study Sites (78)

Anniston, Alabama Site

Anniston, Alabama, 36207, United States

Location

Mission Hills Site

Mission Hills, California, 91345, United States

Location

Orange Site

Orange, California, 92868, United States

Location

Thousands Oaks Site

Thousand Oaks, California, 91360, United States

Location

Miami, FL Site

Miami, Florida, 33014, United States

Location

Tampa, Florida Site

Tampa, Florida, 33765, United States

Location

Wheaton, Maryland Site

Wheaton, Maryland, 20902, United States

Location

Grand Blanc Site

Grand Blanc, Michigan, 48439, United States

Location

Baytown Site

Baytown, Texas, 77521, United States

Location

Colleyville, Texas Site

Colleyville, Texas, 76034, United States

Location

Houston Site

Houston, Texas, 77084, United States

Location

Waco Site

Waco, Texas, 76710, United States

Location

Quilmes Site

Quilmes, Buenos Aires, B1878DVB, Argentina

Location

Rosario Site

Rosario, Santa Fe Province, S2000PBJ, Argentina

Location

San Miguel de Tucuman Site 1

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

San Miguel de Tucuman Site 2

San Miguel de Tucumán, Tucumán Province, T4000ICL, Argentina

Location

Ciudad Autonoma Buenos Aires Site 2

Ciudad Autonoma Buenos Aires, C1046AAQ, Argentina

Location

Cordoba Site

Córdoba, X5000AVE, Argentina

Location

San Juan Site

San Juan, 5400, Argentina

Location

Garran Site

Garran, Austl. Cap. Terr., 2605, Australia

Location

Murdoch Site

Murdoch, Western Australia, 6150, Australia

Location

Pleven Site

Pleven, 5800, Bulgaria

Location

Plovdiv Site

Plovdiv, 4023, Bulgaria

Location

Ruse Site

Rousse, 7002, Bulgaria

Location

Sevlievo Site

Sevlievo, 5400, Bulgaria

Location

Sofia Site 1

Sofia, 1431, Bulgaria

Location

Sofia Site 4

Sofia, 1463, Bulgaria

Location

Sofia Site 5

Sofia, 1463, Bulgaria

Location

Sofia Site 3

Sofia, 1612, Bulgaria

Location

Stara Zagora Site

Stara Zagora, 6000, Bulgaria

Location

Santiago Site 4

Santiago, 7500010, Chile

Location

Santiago Site 1

Santiago, 7500710, Chile

Location

Santiago Site 3

Santiago, 7501126, Chile

Location

Santiago Site 2

Santiago, 8330336, Chile

Location

Barranquilla site

Barranquilla, 080002, Colombia

Location

Barranquilla site

Barranquilla, 080020, Colombia

Location

Bucaramanga site

Bucaramanga, 680003, Colombia

Location

Medellin Site 1

Medellín, 050025, Colombia

Location

Medellin site 2

Medellín, 50021, Colombia

Location

Monteria site

Montería, 230002, Colombia

Location

Koeln Site

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Muenster Site

Münster, North Rhine-Westphalia, 48149, Germany

Location

Guatemala site

Guatemala City, Guatemala

Location

Budapest Site

Budapest, 1097, Hungary

Location

Debrecen Site

Debrecen, 4032, Hungary

Location

Gyula Site

Gyula, 5700, Hungary

Location

Quatre Bornes Site

Quatre Bornes, 72218, Mauritius

Location

Cuernavaca Site

Cuernavaca, 62448, Mexico

Location

Guadalajara Site

Guadalajara, 44670, Mexico

Location

Ciudad de Mexico Site

Mexico City, 06700, Mexico

Location

Mexico site 1

México, 06760, Mexico

Location

Mexico Site 2

México, 67000, Mexico

Location

Batangas Site

Batangas, 4217, Philippines

Location

Cagayan de Oro City Site

Cagayan de Oro, 9000, Philippines

Location

Los Baños Site

Los Baños, 4030, Philippines

Location

Makati City Site

Makati City, 1229, Philippines

Location

Manila Site

Manila, 1012, Philippines

Location

Bydgoszcz Site

Bydgoszcz, 85-065, Poland

Location

Bydgoszcz Site 2

Bydgoszcz, 85-168, Poland

Location

Bydgoszcz Site 3

Bydgoszcz, 85-605, Poland

Location

Bytom Site

Bytom, 41-902, Poland

Location

Katowice Site

Katowice, 40-748, Poland

Location

Krakow Site 1

Krakow, 31-501, Poland

Location

Lodz Site

Lodz, 90-368, Poland

Location

Malbork Site

Malbork, 82-200, Poland

Location

Poznan Site 2

Poznan, 60-681, Poland

Location

Poznan SIte

Poznan, 61-113, Poland

Location

Poznań Site

Poznan, 61-731, Poland

Location

Szczecin Site

Szczecin, 71-252, Poland

Location

Warszawa Site 2

Warsaw, 00-874, Poland

Location

Warszawa Site 3

Warsaw, 02-637, Poland

Location

Warszawa Site

Warsaw, 04-305, Poland

Location

Wroclaw Site 2

Wroclaw, 50-556, Poland

Location

Caguas Site

Caguas, 00725, Puerto Rico

Location

San Juan Site

San Juan, 00917, Puerto Rico

Location

Sevilla Site 1

Seville, 41010, Spain

Location

Sevilla Site 2

Seville, 41013, Spain

Location

Valencia Site

Valencia, 46017, Spain

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

telitacicept

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 1, 2022
• Study Start: June 20, 2022
• Primary Completion: January 6, 2025
• Study Completion: January 6, 2025
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); MA (1); US (12); GU (1); CL (4); BU (9); HU (3); AU (2); PH (5); AR (7); ME (5); PL (16); CO (6); PR (2); DE (2)