Telitacicept for Myasthenia Gravis
Recruiting in Palo Alto (17 mi)
+12 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: RemeGen Co., Ltd.
Disqualifiers: Autoimmune disease, Infection, Thymoma, Immunodeficiency, Malignancy, Cardiovascular, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How is the drug Telitacicept different from other treatments for myasthenia gravis?
Telitacicept is unique because it targets specific immune system components involved in autoimmune diseases, potentially offering a novel approach compared to existing treatments for myasthenia gravis, which often focus on general immune suppression or symptom management.
12345Eligibility Criteria
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.Inclusion Criteria
My tests show positive for antibodies against AChR or MuSK.
I am 18 years old or older.
MG-ADL score ≥6 points at screening and baseline with ocular-related score <50% of the total score
+2 more
Exclusion Criteria
I am currently dealing with an infection.
I had thymoma within the last 5 years or a thymectomy within the last 6 months.
Patients having current or history of primary immunodeficiency
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive telitacicept or placebo in a double-blind manner to evaluate efficacy and safety in treating generalized myasthenia gravis
24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Open-label extension
Participants may opt into continuation of treatment with telitacicept long-term
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TelitaciceptExperimental Treatment1 Intervention
Telitacicept
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Telitacicept is already approved in China for the following indications:
🇨🇳 Approved in China as Tai'ai for:
- Systemic lupus erythematosus (SLE)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Port Charlotte, Florida SitePort Charlotte, FL
Orange SiteOrange, CA
Boca Raton, Florida SiteBoca Raton, FL
Miami, Florida SiteMiami, FL
More Trial Locations
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Who Is Running the Clinical Trial?
RemeGen Co., Ltd.Lead Sponsor
References
A Sum Score to Define Therapy-Refractory Myasthenia Gravis: A German Consensus. [2022]In 2017, eculizumab has been approved for treatment-refractory generalised myasthenia gravis (TRgMG). The German Myasthenia Foundation has published a consensus statement on the use of eculizumab, with a recent update. However, a treatment-refractory state is still ill-defined and the term warrants further clarification. We aimed at developing a sum score to operationalise the definition of a TRgMG status, which is easy- to-handle in clinical decision making.
Acupuncture for patients with myasthenia gravis: A systematic review protocol. [2022]The objective of this systematic review protocol is to provide the methods for evaluating the effectiveness and safety of acupuncture on the treatment of myasthenia gravis (MG).
The best and worst of times in therapy development for myasthenia gravis. [2023]Within the last 5 years, the US Food and Drug Administration (FDA) has approved complement and neonatal Fc receptor (FcRN) inhibitors for treatment of generalized myasthenia gravis, and several other therapies are in late-stage clinical trials or under regulatory review. However, questions about which patients are most likely to benefit from which therapies, and the relative effectiveness of these very expensive drugs, has resulted in uncertainty around the place that they should occupy in the existing therapeutic armamentarium. MGNet (a Rare Diseases Clinical Research Consortium funded by the National Institute of Neurological Diseases and Stroke) held two meetings during the 14th International Conference of the Myasthenia Gravis Foundation of America to discuss the most critical needs for clinical trial readiness and biomarker development in the context of therapy development for myasthenia gravis. Herein we provide a summary of these discussions, but not a consensus opinion, and offer a series of recommendations to guide focused research in the most critical areas. We welcome ongoing discussion through comments on this work.
Comparative effectiveness clinical trials to advance treatment of myasthenia gravis. [2019]Myasthenia gravis (MG) presents many challenges for establishing treatment efficacy through clinical trials. Among these are the rarity and heterogeneity of the disease, spontaneous fluctuations, prolonged latency to effect for many immunosuppressive drugs, and the uncertain generalizability of results from randomized controlled trials (RCTs). Prospective observational study designs may overcome some of these limitations, but attention is required to ensure that internal validity is not compromised. Observational comparative effectiveness research (CER) utilizes data obtained during routine clinical care to evaluate the effectiveness of interventions in real-life practice conditions, thereby improving generalizability to the clinic. Compared with RCTs, observational CER studies may be less resource intensive and costly. Recent advances that have improved the feasibility of CER studies for MG are (1) the development of MG common data elements, (2) the publication of international consensus guidance for MG treatment, and (3) the development of a web-based REDCap database that can be shared and adapted to standardize data collection. This infrastructure could be used for multisite comparisons of commonly used therapies and provides longitudinal information on patient- and clinician-centered MG outcome measures. A challenge is to design studies that address the potential limitations of observational trials, such as confounding and selection and information bias.
Telephone consultation for myasthenia gravis care during the COVID-19 pandemic: Assessment of a novel virtual myasthenia gravis index. [2023]The aim of the study was to determine the association between the virtual Myasthenia Gravis Impairment Index (vMGII) with other patient-reported outcomes (PROs) of myasthenia gravis (MG) and its usefulness in telephone consultations with MG patients.