A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study with an Open-label Extension Period to Evaluate the Efficacy and Safety of Telitacicept in Patients with Generalized Myasthenia Gravis
IRAS ID
1009988
Contact name
Asli Mohamud
Contact email
Sponsor organisation
RemeGen Co., Ltd.
Clinicaltrials.gov Identifier
Research summary
The primary objective of the trial is to evaluate the efficacy of telitacicept in 180 patients (men and women) compared to a placebo (a substance that looks like the study drug but contains no active drug) in people with generalized myasthenia gravis (gMG). Participants will be 18 years old or older when joining the study.
The participants will be assigned by random chance (like flip a coin) in a 1:1 ratio to receive either telitacicept 240mg or a placebo, which looks like the study drug but does not have any medicine in it. Participants will receive this treatment via subcutaneous (SC) injections once weekly, over the course of about 24 weeks. Next phase of the study is the open-label period, which means that both the participants and study staff will know that the participants will receive the study drug – telitacicept as dosage of 240mg. They will receive this treatment via subcutaneous injections once weekly over the course of about 48 weeks.
The study staff will monitor participants' overall health throughout the study, conducting physical examinations, assessing vital signs, and collecting blood and urine samples to ensure the safety of the participants. They will also utilize scales to measure the efficacy of the treatment for this disease. Additionally, questionnaires will be used to assess how the participants' disease is impacting their daily activities. Furthermore, blood samples will be collected to understand how the treatment acts inside the bodies of participants with this disease.
Participants might not directly benefit from taking part in the study, but their involvement could help improve the care for other patients with gMG in the future.REC name
London - Central Research Ethics Committee
REC reference
24/LO/0820
Date of REC Opinion
11 Dec 2024
REC opinion
Further Information Unfavourable Opinion