Save

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

PHASE3ACTIVE_NOT_RECRUITING

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

Simpliy with AI

Study 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, 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.

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Age 12-70 years at screening.

Has a diagnosis of SLE for at least 6 months prior to the screening visit.

Meets the 2019 EULAR/ACR Classification criteria for SLE.

Moderately to severely active SLE defined by the following:

SELENA SLEDAI total score ≥6 points with clinical SLEDAI score ≥4 points at screening;

BILAG organ system scores of at least 1A or 2B at screening.

Clinical SLEDAI score of ≥4 at Day 0 prior to randomization.

At least one positive serologic parameter within the screening period.

Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.

Exclusion criteria

Active lupus nephritis undergoing induction therapy or unstable renal diseases within 12 weeks prior to screening.

Active or unstable neuropsychiatric SLE.

Autoimmune or rheumatic disease other than SLE

Simplify with AI

Eligibility

Age eligible for study : 12 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-06-20

Primary completion: 2027-01-02

Study completion finish: 2027-03-02

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT05306574

Intervention or treatment

DRUG: Telitacicept

DRUG: Placebo

Conditions

• Systemic Lupus Erythematosus

Image related to Systemic Lupus Erythematosus

Condition: Systemic Lupus Erythematosus
DRUG: Telitacicept and other drugs
Garran, Austl. Cap. Terr., Australia and more
Sponsor: RemeGen Co., Ltd.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Garran Site

Research sites nearby

Select from list below to view details:

Garran Site
Garran, Austl. Cap. Terr., Australia
Murdoch Site
Murdoch, Western Australia, Australia

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?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Telitacicept 160 mg Telitacicept 160 mg + SOC	DRUG: Telitacicept subcutaneous injection weekly for 52 weeks
EXPERIMENTAL: Telitacicept 240 mg Telitacicept 240 mg + SOC	DRUG: Telitacicept subcutaneous injection weekly for 52 weeks
PLACEBO_COMPARATOR: Placebo Placebo + SOC	DRUG: Placebo subcutaneous injection weekly for 52 weeks

What is the study measuring?

Primary outcome

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

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Key secondary endpoint for Stage 2: BILAG-based Combined Lupus Assessment (BICLA)	Proportion of patients achieving a response in BICLA	Week 52
Key secondary endpoint for Stage 2: achieve and sustain a low dose of corticosteroid	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	Severe flare according to the SLEDAI Flare Index (SFI)	Week 52

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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