A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (RemeMG)

Description

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.

Conditions

Generalized Myasthenia Gravis

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Study Overview

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Study Details

Study overview

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.

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

A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (RemeMG)

Condition
Generalized Myasthenia Gravis
Intervention / Treatment

-

Contacts and Locations

Boca Raton

Boca Raton, Florida Site, Boca Raton, Florida, United States, 33487

Miami

Miami, Florida Site, Miami, Florida, United States, 33155

Port Charlotte

Port Charlotte, Florida Site, Port Charlotte, Florida, United States, 33952

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male or female patient aged ≥18 years at screening.
  • 2. Patients have prior confirmed diagnosis of gMG with generalized muscle weakness (typical pattern of weakness meeting the clinical criteria for diagnosis of MG as defined by the Myasthenia Gravis Foundation of America (MGFA) clinical classification II-IV.
  • 3. Patients have positive antibodies against AChR or MuSK at screening.
  • 4. MG-ADL score ≥6 points at screening and baseline with ocular-related score \<50% of the total score.
  • 5. QMG score ≥11 points at screening and baseline.
  • 1. Patients have been diagnosed with any other autoimmune disease.
  • 2. Patients having acute or chronic infection.
  • 3. Patients having thymoma within 5 years or received thymectomy ≤6 months prior to screening.
  • 4. Patients having current or history of primary immunodeficiency.
  • 5. Patients having history of malignancy within the last 5 years.
  • 6. Patient having prior or continuing diagnosis of serious cardiovascular disease.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

RemeGen Co., Ltd.,

Study Record Dates

2027-10