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Monoclonal Antibodies

Telitacicept for Myasthenia Gravis

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
Patients have positive antibodies against AChR or MuSK at screening
Male or female patient aged ≥18 years at screening
Must not have
Patients having acute or chronic infection
Patients having thymoma within 5 years or received thymectomy ≤6 months prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights
Pivotal Trial

Summary

This trial aims to test how well and safely telitacicept works in treating generalized myasthenia gravis.

Who is the study for?
This trial is for adults over 18 with generalized myasthenia gravis, a muscle weakness condition. Participants must have certain antibodies and scores indicating moderate to severe symptoms but not solely ocular-related. They should have a confirmed diagnosis fitting specific MGFA clinical classifications.
What is being tested?
The study is testing Telitacicept's effectiveness and safety in treating generalized myasthenia gravis compared to a placebo. Patients will be randomly assigned to receive either the actual medication or an inactive substance.
What are the potential side effects?
While the side effects of Telitacicept are not detailed here, similar medications often cause reactions at injection sites, infections due to immune system suppression, headaches, nausea, and possibly abnormal blood test results.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tests show positive for antibodies against AChR or MuSK.
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I am 18 years old or older.
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I have been diagnosed with generalized Myasthenia Gravis (MG) and experience muscle weakness.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently dealing with an infection.
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I had thymoma within the last 5 years or a thymectomy within the last 6 months.
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I have had cancer within the last 5 years.
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I have a serious heart condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score at Week 24
Secondary study objectives
Change from baseline in MG Quality of Life scale (MG-QOL15r) at Week 24
Change from baseline in Quantitative Myasthenia Gravis (QMG) score at Week 24
Proportion of patients who achieved minimal symptomatic expression (MSE, defined as having MG-ADL score of 0 or 1) at Week 24
+2 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
Group II: PlaceboPlacebo Group1 Intervention
Placebo
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
10,878 Total Patients Enrolled
2 Trials studying Myasthenia Gravis
129 Patients Enrolled for Myasthenia Gravis
~120 spots leftby Jul 2026
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