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

January 7, 2026 updated by: Vor Biopharma

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 (REMESLE-1)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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, 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.

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina, C1046AAQ
        • Ciudad Autonoma Buenos Aires Site 2
      • Córdoba, Argentina, X5000AVE
        • Cordoba Site
      • San Juan, Argentina, 5400
        • San Juan Site
    • Buenos Aires
      • Quilmes, Buenos Aires, Argentina, B1878DVB
        • Quilmes Site
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000PBJ
        • Rosario Site
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
        • San Miguel de Tucuman Site 1
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000ICL
        • San Miguel de Tucuman Site 2
  • Australia
    • Austl. Cap. Terr.
      • Garran, Austl. Cap. Terr., Australia, 2605
        • Garran Site
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Murdoch Site
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Pleven Site
      • Plovdiv, Bulgaria, 4023
        • Plovdiv Site
      • Rousse, Bulgaria, 7002
        • Ruse Site
      • Sevlievo, Bulgaria, 5400
        • Sevlievo Site
      • Sofia, Bulgaria, 1431
        • Sofia Site 1
      • Sofia, Bulgaria, 1463
        • Sofia Site 4
      • Sofia, Bulgaria, 1463
        • Sofia Site 5
      • Sofia, Bulgaria, 1612
        • Sofia Site 3
      • Stara Zagora, Bulgaria, 6000
        • Stara Zagora Site
  • Chile
      • Santiago, Chile, 7500010
        • Santiago Site 4
      • Santiago, Chile, 7500710
        • Santiago Site 1
      • Santiago, Chile, 7501126
        • Santiago Site 3
      • Santiago, Chile, 8330336
        • Santiago Site 2
  • Colombia
      • Barranquilla, Colombia, 080002
        • Barranquilla site
      • Barranquilla, Colombia, 080020
        • Barranquilla site
      • Bucaramanga, Colombia, 680003
        • Bucaramanga site
      • Medellín, Colombia, 050025
        • Medellin Site 1
      • Medellín, Colombia, 50021
        • Medellin site 2
      • Montería, Colombia, 230002
        • Monteria site
  • Germany
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Koeln Site
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Muenster Site
  • Guatemala
      • Guatemala City, Guatemala
        • Guatemala site
  • Hungary
      • Budapest, Hungary, 1097
        • Budapest Site
      • Debrecen, Hungary, 4032
        • Debrecen Site
      • Gyula, Hungary, 5700
        • Gyula Site
  • Mauritius
      • Quatre Bornes, Mauritius, 72218
        • Quatre Bornes Site
  • Mexico
      • Cuernavaca, Mexico, 62448
        • Cuernavaca Site
      • Guadalajara, Mexico, 44670
        • Guadalajara Site
      • Mexico City, Mexico, 06700
        • Ciudad de Mexico Site
      • México, Mexico, 06760
        • Mexico site 1
      • México, Mexico, 67000
        • Mexico Site 2
  • Philippines
      • Batangas, Philippines, 4217
        • Batangas Site
      • Cagayan de Oro, Philippines, 9000
        • Cagayan de Oro City Site
      • Los Baños, Philippines, 4030
        • Los Baños Site
      • Makati City, Philippines, 1229
        • Makati City Site
      • Manila, Philippines, 1012
        • Manila Site
  • Poland
      • Bydgoszcz, Poland, 85-065
        • Bydgoszcz Site
      • Bydgoszcz, Poland, 85-168
        • Bydgoszcz Site 2
      • Bydgoszcz, Poland, 85-605
        • Bydgoszcz Site 3
      • Bytom, Poland, 41-902
        • Bytom Site
      • Katowice, Poland, 40-748
        • Katowice Site
      • Krakow, Poland, 31-501
        • Krakow Site 1
      • Lodz, Poland, 90-368
        • Lodz Site
      • Malbork, Poland, 82-200
        • Malbork Site
      • Poznan, Poland, 60-681
        • Poznan Site 2
      • Poznan, Poland, 61-113
        • Poznań Site
      • Poznan, Poland, 61-731
        • Poznań Site
      • Szczecin, Poland, 71-252
        • Szczecin Site
      • Warsaw, Poland, 00-874
        • Warszawa Site 2
      • Warsaw, Poland, 02-637
        • Warszawa Site 3
      • Warsaw, Poland, 04-305
        • Warszawa Site
      • Wroclaw, Poland, 50-556
        • Wroclaw Site 2
  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Caguas Site
      • San Juan, Puerto Rico, 00917
        • San Juan Site
  • Spain
      • Seville, Spain, 41010
        • Sevilla Site 1
      • Seville, Spain, 41013
        • Sevilla Site 2
      • Valencia, Spain, 46017
        • Valencia Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Anniston, Alabama Site
    • California
      • Mission Hills, California, United States, 91345
        • Mission Hills Site
      • Orange, California, United States, 92868
        • Orange Site
      • Thousand Oaks, California, United States, 91360
        • Thousands Oaks Site
    • Florida
      • Miami, Florida, United States, 33014
        • Miami, FL Site
      • Tampa, Florida, United States, 33765
        • Tampa, Florida Site
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • Wheaton, Maryland Site
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Grand Blanc Site
    • Texas
      • Baytown, Texas, United States, 77521
        • Baytown Site
      • Colleyville, Texas, United States, 76034
        • Colleyville, Texas Site
      • Houston, Texas, United States, 77084
        • Houston Site
      • Waco, Texas, United States, 76710
        • Waco Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 12-70 years at screening.
  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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telitacicept
Telitacicept + Standard of Care (SoC)
Biological: Telitacicept
Subcutaneous injection weekly for 52 weeks
Other Names:
  • RC18
  • RC18-L
Placebo Comparator: Placebo
Placebo + Standard of Care (SoC)
Biological: Placebo
Subcutaneous injection weekly for 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SLE Responder Index (SRI-4)
Time Frame: Week 52
Proportion of subjects achieving an SLE Responder Index (SRI-4) response at Week 52
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SLE Responder Index (SRI-4) and sustaining a low dose of corticosteriods
Time Frame: Week 52
Proportion of patients achieving an SRI-4 response at Week 52, while achieving and maintaining corticosteroids reduction.
Week 52
BILAG-based Combined Lupus Assessment (BICLA) Response
Time Frame: Week 52
Proportion of patients achieving a BILAG-based Combined Lupus Assessment (BICLA) response at Week 52
Week 52
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Time Frame: Week 52
Proportion of patients achieving clinically meaningful improvement in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52
Week 52
SLE Responder Index (SRI-4)
Time Frame: Week 24
Proportion of subjects achieving an SLE Responder Index (SRI-4) response at Week 24
Week 24
Achieve and sustain a low dose of corticosteriods
Time Frame: Weeks 52
Proportion of subjects achieving the target of corticosteroids reduction through Week 52.
Weeks 52
Time to Flare
Time Frame: Week 52
Time to flare assessed by SELENA-SLEDAI Flare Index (SFI) from baseline through Week 52
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vor Biopharma

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 Major Dates

Study Start (Actual)

June 20, 2022

Primary Completion (Actual)

January 6, 2025

Study Completion (Actual)

January 6, 2025

Study Registration Dates

First Submitted

March 23, 2022

First Submitted That Met QC Criteria

March 23, 2022

First Posted (Actual)

April 1, 2022

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC18G001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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