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Monoclonal Antibodies

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
Age 12-70 years at screening.
Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
Pivotal Trial

Summary

"This trial aims to see if telitacicept is effective and safe in treating people with moderately to severely active systemic lupus erythematosus (SLE)."

Who is the study for?
This trial is for people aged 12-70 with moderately to severely active Systemic Lupus Erythematosus (SLE). Participants must have been diagnosed at least 6 months prior and meet specific SLE criteria, including a minimum disease activity score. They should be on standard treatments like steroids or antimalarials.
What is being tested?
The study tests Telitacicept's effectiveness and safety against a placebo in treating SLE. Participants will randomly receive either the actual drug or a placebo without knowing which one they are getting, to compare outcomes fairly.
What are the potential side effects?
While not specified here, potential side effects of Telitacicept may include reactions at the injection site, increased risk of infections due to immune system suppression, and possible abnormal blood test results.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 12 and 70 years old.
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I am currently taking medication for my lupus.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Achieve and sustain a low dose of corticosteriods
BILAG-based Combined Lupus Assessment (BICLA) Response
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
+3 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TelitaciceptExperimental Treatment1 Intervention
Telitacicept + Standard of Care (SOC)
Group II: PlaceboPlacebo Group1 Intervention
Placebo + Standard of Care (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
82 Previous Clinical Trials
10,708 Total Patients Enrolled
~233 spots leftby Apr 2027
Unbiased ResultsWe believe in providing patients with all the options.
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