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

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ClinicalTrials.gov Identifier: NCT05306574
Recruitment Status : Recruiting
First Posted : April 1, 2022
Last Update Posted : November 18, 2023
Sponsor:
Information provided by (Responsible Party):
RemeGen Co., Ltd.

Tracking Information
First Submitted Date  ICMJE March 23, 2022
First Posted Date  ICMJE April 1, 2022
Last Update Posted Date November 18, 2023
Actual Study Start Date  ICMJE June 20, 2022
Estimated Primary Completion Date June 29, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2022)
  • Primary Endpoint for Stage 1: SLE Responder Index (SRI-4) [ Time Frame: Week 24 ]
    Proportion of patients achieving a response in SRI-4
  • Primary Endpoint for Stage 2: SLE Responder Index (SRI-4) [ Time Frame: Week 52 ]
    Proportion of patients achieving a response in SRI-4
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2022)
  • Key secondary endpoint for Stage 2: BILAG-based Combined Lupus Assessment (BICLA) [ Time Frame: Week 52 ]
    Proportion of patients achieving a response in BICLA
  • 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
  • Key secondary endpoint for Stage 2: Annualized severe flare rate [ Time Frame: Week 52 ]
    Severe flare according to the SLEDAI Flare Index (SFI)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: Telitacicept
    subcutaneous injection weekly for 52 weeks
    Other Name: RC18
  • Drug: Placebo
    subcutaneous injection weekly for 52 weeks
Study Arms  ICMJE
  • Experimental: Telitacicept 160 mg
    Telitacicept 160 mg + SOC
    Intervention: Drug: Telitacicept
  • Experimental: Telitacicept 240 mg
    Telitacicept 240 mg + SOC
    Intervention: Drug: Telitacicept
  • Placebo Comparator: Placebo
    Placebo + SOC
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 23, 2022)
341
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 21, 2025
Estimated Primary Completion Date June 29, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: RemeGen 301-284-1015 RC18_SLEstudy@remegenbio.com
Listed Location Countries  ICMJE Argentina,   Australia,   Bulgaria,   Chile,   Colombia,   Germany,   Hungary,   Philippines,   Poland,   Puerto Rico,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05306574
Other Study ID Numbers  ICMJE RC18G001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party RemeGen Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE RemeGen Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account RemeGen Co., Ltd.
Verification Date November 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP