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

November 16, 2023 updated by: RemeGen Co., Ltd.

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.

Study Overview

Status

Recruiting

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, BCMA, and 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 operationally seamless study to evaluate the efficacy and safety of telitacicept 160 mg and 240 mg in a global patient population with active SLE disease.

  • Stage 1 - a dose ranging study to evaluate the efficacy, safety, pharmacokinetics (PK) and PD of telitacicept 160 mg and 240 mg in an international cohort of adult SLE patients.
  • Stage 2 - a confirmatory efficacy study to evaluate the telitacicept dose selected from Stage 1.

Study Type

Interventional

Enrollment (Estimated)

341

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 Contact

Study Locations

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina, C1046AAQ
        • Recruiting
        • Ciudad Autonoma Buenos Aires Site 2
      • Cordoba, Argentina, X5000AVE
        • Not yet recruiting
        • Cordoba Site
      • San Juan, Argentina, 5400
        • Recruiting
        • San Juan Site
    • Buenos Aires
      • Quilmes, Buenos Aires, Argentina, B1878DVB
        • Recruiting
        • Quilmes Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000PBJ
        • Not yet recruiting
        • Rosario Site
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, T4000AXL
        • Recruiting
        • San Miguel de Tucuman Site 1
      • San Miguel de Tucuman, Tucuman, Argentina, T4000ICL
        • Recruiting
        • San Miguel de Tucuman Site 2
  • Australia
    • Austl. Cap. Terr.
      • Garran, Austl. Cap. Terr., Australia, 2605
        • Not yet recruiting
        • Garran Site
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • Murdoch Site
  • Bulgaria
      • Kardzhali, Bulgaria, 6600
        • Recruiting
        • Kardzhali Site
      • Pleven, Bulgaria, 5800
        • Recruiting
        • Pleven Site
      • Plovdiv, Bulgaria, 4023
        • Recruiting
        • Plovdiv Site
      • Ruse, Bulgaria, 7002
        • Recruiting
        • Ruse Site
      • Sevlievo, Bulgaria, 5400
        • Recruiting
        • Sevlievo Site
      • Sofia, Bulgaria, 1431
        • Recruiting
        • Sofia Site 1
      • Sofia, Bulgaria, 1606
        • Recruiting
        • Sofia Site 2
      • Sofia, Bulgaria, 1612
        • Not yet recruiting
        • Sofia Site 3
      • Sofia, Bulgaria, 1463
        • Recruiting
        • Sofia Site 4
      • Sofia, Bulgaria, 1463
        • Recruiting
        • Sofia Site 5
      • Stara Zagora, Bulgaria, 6000
        • Recruiting
        • Stara Zagora Site
  • Chile
      • Santiago, Chile, 7500710
        • Recruiting
        • Santiago Site 1
      • Santiago, Chile, 7500010
        • Recruiting
        • Santiago Site 4
      • Santiago, Chile, 8330336
        • Recruiting
        • Santiago Site 2
      • Santiago, Chile, 7501126
        • Recruiting
        • Santiago Site 3
      • Viña del Mar, Chile, 2520598
        • Recruiting
        • Viña del Mar Site
  • Colombia
      • Barranquilla, Colombia, 080002
        • Not yet recruiting
        • Barranquilla site
      • Barranquilla, Colombia, 080020
        • Not yet recruiting
        • Barranquilla site
      • Bogotá, Colombia, 110221
        • Not yet recruiting
        • Bogotá site
      • Bucaramanga, Colombia, 680003
        • Not yet recruiting
        • Bucaramanga site
      • Medellin, Colombia, 050025
        • Not yet recruiting
        • Medellin Site 1
      • Medellin, Colombia, 50021
        • Not yet recruiting
        • Medellin site 2
      • Monteria, Colombia, 230002
        • Not yet recruiting
        • Monteria site
  • Germany
    • Nordrhein Westfalen
      • Koeln, Nordrhein Westfalen, Germany, 50937
        • Recruiting
        • Koeln Site
      • Muenster, Nordrhein Westfalen, Germany, 48149
        • Recruiting
        • Muenster Site
  • Hungary
      • Budapest, Hungary, 1097
        • Not yet recruiting
        • Budapest Site
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debrecen Site
      • Gyula, Hungary, 5700
        • Recruiting
        • Gyula Site
  • Philippines
      • Batangas, Philippines, 4217
        • Recruiting
        • Batangas Site
      • Cagayan De Oro, Philippines, 9000
        • Recruiting
        • Cagayan de Oro City Site
      • Los Baños, Philippines, 4030
        • Recruiting
        • Los Baños Site
      • Makati City, Philippines, 1229
        • Recruiting
        • Makati City Site
      • Manila, Philippines, 1012
        • Recruiting
        • Manila Site
  • Poland
      • Bydgoszcz, Poland, 85-065
        • Recruiting
        • Bydgoszcz Site
      • Bydgoszcz, Poland, 85-168
        • Recruiting
        • Bydgoszcz Site 2
      • Bydgoszcz, Poland, 85-605
        • Recruiting
        • Bydgoszcz Site 3
      • Bytom, Poland, 41-902
        • Recruiting
        • Bytom Site
      • Katowice, Poland, 40-748
        • Recruiting
        • Katowice Site
      • Krakow, Poland, 30-348
        • Recruiting
        • Krakow Site 2
      • Krakow, Poland, 31-501
        • Recruiting
        • Krakow Site 1
      • Lodz, Poland, 90-368
        • Recruiting
        • Lodz Site
      • Lodz, Poland, 91-053
        • Recruiting
        • Lodz Site 2
      • Malbork, Poland, 82-200
        • Recruiting
        • Malbork Site
      • Poznan, Poland, 60-681
        • Recruiting
        • Poznan Site 2
      • Poznan, Poland, 61-113
        • Recruiting
        • Poznań Site
      • Poznań, Poland, 61-731
        • Recruiting
        • Poznań Site
      • Sosnowiec, Poland, 41-200
        • Not yet recruiting
        • Sosnowiec Site
      • Szczecin, Poland, 71-252
        • Recruiting
        • Szczecin Site
      • Warszawa, Poland, 00-874
        • Recruiting
        • Warszawa Site 2
      • Warszawa, Poland, 04-305
        • Recruiting
        • Warszawa Site
      • Warszawa, Poland, 02-637
        • Recruiting
        • Warszawa Site 3
      • Wroclaw, Poland, 52-416
        • Recruiting
        • Wroclaw Site
      • Wroclaw, Poland, 50-556
        • Recruiting
        • Wroclaw Site 2
  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Recruiting
        • Caguas Site
      • San Juan, Puerto Rico, 00917
        • Recruiting
        • San Juan Site
  • Spain
      • Barcelona, Spain, 08036
        • Not yet recruiting
        • Barcelona Site
      • Granada, Spain, 18016
        • Recruiting
        • Granada Site
      • Sevilla, Spain, 41010
        • Recruiting
        • Sevilla Site 1
      • Sevilla, Spain, 41013
        • Recruiting
        • Sevilla Site 2
      • Valencia, Spain, 46017
        • Recruiting
        • Valencia Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Completed
        • Anniston, Alabama Site
      • Birmingham, Alabama, United States, 35216
        • Recruiting
        • Birmingham, Alabama Site
    • California
      • Huntington Park, California, United States, 90255
        • Recruiting
        • Huntington Park, California Site
      • La Mesa, California, United States, 91942
        • Recruiting
        • La Mesa Site
      • Mission Hills, California, United States, 91345
        • Recruiting
        • Mission Hills Site
      • Thousand Oaks, California, United States, 91360
        • Completed
        • Thousands Oaks Site
    • Florida
      • DeBary, Florida, United States, 32713
        • Recruiting
        • Debary, Florida Site
      • Fort Lauderdale, Florida, United States, 33321
        • Recruiting
        • Fort Lauderdale, FL Site
      • Miami, Florida, United States, 33014
        • Completed
        • Miami, FL Site
      • Orlando, Florida, United States, 32819
        • Recruiting
        • Orlando Site
      • Tampa, Florida, United States, 33765
        • Recruiting
        • Tampa, Florida Site
    • Illinois
      • Rockford, Illinois, United States, 61114
        • Recruiting
        • Rockford Site
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • Completed
        • Wheaton, Maryland Site
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Recruiting
        • Grand Blanc Site
    • Minnesota
      • Eagan, Minnesota, United States, 55121
        • Recruiting
        • Eagan Site
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • Recruiting
        • Salisbury Site
    • Texas
      • Baytown, Texas, United States, 77521
        • Recruiting
        • Baytown Site
      • Colleyville, Texas, United States, 76034
        • Recruiting
        • Colleyville, Texas Site
      • Houston, Texas, United States, 77084
        • Completed
        • Houston Site
      • Waco, Texas, United States, 76710
        • Recruiting
        • 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. 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.

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 160 mg
Telitacicept 160 mg + SOC
Drug: Telitacicept
subcutaneous injection weekly for 52 weeks
Other Names:
  • RC18
Experimental: Telitacicept 240 mg
Telitacicept 240 mg + SOC
Drug: Telitacicept
subcutaneous injection weekly for 52 weeks
Other Names:
  • RC18
Placebo Comparator: Placebo
Placebo + SOC
Drug: Placebo
subcutaneous injection weekly for 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Endpoint for Stage 1: SLE Responder Index (SRI-4)
Time Frame: Week 24
Proportion of patients achieving a response in SRI-4
Week 24
Primary Endpoint for Stage 2: SLE Responder Index (SRI-4)
Time Frame: Week 52
Proportion of patients achieving a response in SRI-4
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Key secondary endpoint for Stage 2: BILAG-based Combined Lupus Assessment (BICLA)
Time Frame: Week 52
Proportion of patients achieving a response in BICLA
Week 52
Key secondary endpoint for Stage 2: achieve and sustain a low dose of corticosteroid
Time Frame: Weeks 40 - 52
Proportion of patients who achieve or maintain prednisone </= 7.5 mg/d or equivalent
Weeks 40 - 52
Key secondary endpoint for Stage 2: Annualized severe flare rate
Time Frame: Week 52
Severe flare according to the SLEDAI Flare Index (SFI)
Week 52

Collaborators and Investigators

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

Sponsor

RemeGen Co., Ltd.

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 (Estimated)

June 29, 2025

Study Completion (Estimated)

September 21, 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)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

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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