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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Telitacicept Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 341 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 20, 2022
Estimated Primary Completion Date : June 29, 2025
Estimated Study Completion Date : September 21, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Telitacicept 160 mg
Telitacicept 160 mg + SOC
Drug: Telitacicept
subcutaneous injection weekly for 52 weeks
Other Name: RC18

Experimental: Telitacicept 240 mg
Telitacicept 240 mg + SOC
Drug: Telitacicept
subcutaneous injection weekly for 52 weeks
Other Name: RC18

Placebo Comparator: Placebo
Placebo + SOC
Drug: Placebo
subcutaneous injection weekly for 52 weeks




Primary Outcome Measures :
  1. Primary Endpoint for Stage 1: SLE Responder Index (SRI-4) [ Time Frame: Week 24 ]
    Proportion of patients achieving a response in SRI-4

  2. Primary Endpoint for Stage 2: SLE Responder Index (SRI-4) [ Time Frame: Week 52 ]
    Proportion of patients achieving a response in SRI-4


Secondary Outcome Measures :
  1. Key secondary endpoint for Stage 2: BILAG-based Combined Lupus Assessment (BICLA) [ Time Frame: Week 52 ]
    Proportion of patients achieving a response in BICLA

  2. 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

  3. Key secondary endpoint for Stage 2: Annualized severe flare rate [ Time Frame: Week 52 ]
    Severe flare according to the SLEDAI Flare Index (SFI)



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05306574


Contacts
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Contact: RemeGen 301-284-1015 RC18_SLEstudy@remegenbio.com

Locations
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Sponsors and Collaborators
RemeGen Co., Ltd.
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Responsible Party: RemeGen Co., Ltd.
ClinicalTrials.gov Identifier: NCT05306574    
Other Study ID Numbers: RC18G001
First Posted: April 1, 2022    Key Record Dates
Last Update Posted: November 18, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases