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Telitacicept for Lupus

Phase 3
Recruiting
Research Sponsored by RemeGen Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 40 - 52
Awards & highlights

Study Summary

This trial will test whether telitacicept is safe and effective in treating lupus.

Who is the study for?
This trial is for people with moderately to severely active Systemic Lupus Erythematosus (SLE). Participants must have an hSLEDAI score of ≥ 4, a positive serologic test, and be on standard SLE medications like steroids or antimalarials. They should have been diagnosed with SLE at least 6 months ago. Those with recent infections, cancer history within 5 years, severe lupus complications or other autoimmune diseases can't join.Check my eligibility
What is being tested?
The REMESLE-1 study is testing the effectiveness and safety of Telitacicept in treating SLE. Patients will either receive Telitacicept or a placebo without knowing which one they're getting. The goal is to see if Telitacicept can better manage the symptoms compared to not receiving the active drug.See study design
What are the potential side effects?
While specific side effects are not listed here, treatments like Telitacicept may cause reactions at injection sites, increase infection risk due to immune system suppression, cause headaches, nausea and possibly affect blood cell counts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 40 - 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 40 - 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Endpoint for Stage 1: SLE Responder Index (SRI-4)
Primary Endpoint for Stage 2: SLE Responder Index (SRI-4)
Secondary outcome measures
Key secondary endpoint for Stage 2: Annualized severe flare rate
Lupus erythematosus cell
Adrenal Cortex Hormones

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Telitacicept 240 mgExperimental Treatment1 Intervention
Telitacicept 240 mg + SOC
Group II: Telitacicept 160 mgExperimental Treatment1 Intervention
Telitacicept 160 mg + SOC
Group III: PlaceboPlacebo Group1 Intervention
Placebo + SOC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telitacicept
2022
Completed Phase 1
~100

Find a Location

Who is running the clinical trial?

RemeGen Co., Ltd.Lead Sponsor
74 Previous Clinical Trials
9,719 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05306574 — Phase 3
Lupus Research Study Groups: Telitacicept 160 mg, Placebo, Telitacicept 240 mg
Lupus Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05306574 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05306574 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I sign up to help test this new treatment?

"This study is looking for 341 patients with libman-sacks disease aged between 12 and 70. The most important criteria for applicants are as follows: a positive serologic parameter within the screening period, currently receiving at least one of the SOC SLE medications (e.g. oral corticosteroid, antimalarial and/or immunosuppressive agent), other protocol-defined inclusion criteria may apply, a diagnosis of SLE for at least 6 months prior to the screening visit, hSLEDAI total score ≥ 6 at screening with clinical hSLEDAI score ≥ 4 points, BILAG-2004"

Answered by AI

Has the Telitacicept drug been cleared for use by the FDA?

"As this is a Phase 3 trial, there is available data which supports efficacy as well as safety (from multiple rounds of testing), earning Telitacicept a safety score of 3."

Answered by AI

Are there any available positions for test subjects in this clinical trial?

"Yes, the trial is still open and recruiting patients. The 341 patients will be chosen from 8 different hospitals, as per the information on clinicaltrials.gov. The posting dates you mentioned are accurate."

Answered by AI

How many people have enrolled to be a part of this research project?

"To carry out this clinical trial, 341 eligible patients are needed. The sponsor, RemeGen Co., Ltd., will administer the trial from various locations, for example the Miami, FL and Grand Blanc medical sites."

Answered by AI

Does this research project allow for people who are not yet 50 years old to participate?

"The age bracket for patients that this clinical trial is recruiting is 12 years or older but under 70."

Answered by AI

At how many research sites is this study being conducted?

"Presently, recruitment for this clinical trial is occurring at the Miami, FL, Grand Blanc, and Los Angeles, CA sites. In addition, there are 8 other locations where this trial is being conducted."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Waco Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)
2022. "A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05306574.
All > Systemic Lupus Erythematosus > Lupus
~133 spots leftby Jun 2025
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