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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	12 Years - 70 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05306574
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	RemeGen Co., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Bulgaria, Chile, Colombia, Germany, Hungary, Philippines, Poland, Puerto Rico, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Systemic Lupus Erythematosus

Additional Details

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.

Arms & Interventions

Arms

Experimental: Telitacicept 160 mg

Telitacicept 160 mg + SOC

Experimental: Telitacicept 240 mg

Telitacicept 240 mg + SOC

Placebo Comparator: Placebo

Placebo + SOC

Interventions

Drug: - Telitacicept

subcutaneous injection weekly for 52 weeks

Drug: - Placebo

subcutaneous injection weekly for 52 weeks

Contact a Trial Team

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Anniston, Alabama Site, Anniston, Alabama

Status

Completed

Address

Anniston, Alabama Site

Anniston, Alabama, 36207

Site Contact

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