RECRUITING

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

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Conditions

Generalized Myasthenia GravisMyasthenia GravisgMG

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official 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

Quick Facts

Study Start:2024-07-17
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06456580

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female patient aged ≥18 years at screening.
  2. 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. 3. Patients have positive antibodies against AChR or MuSK at screening.
  4. 4. MG-ADL score ≥6 points at screening and baseline with ocular-related score \<50% of the total score.
  5. 5. QMG score ≥11 points at screening and baseline.
  1. 1. Patients have been diagnosed with any other autoimmune disease.
  2. 2. Patients having acute or chronic infection.
  3. 3. Patients having thymoma within 5 years or received thymectomy ≤6 months prior to screening.
  4. 4. Patients having current or history of primary immunodeficiency.
  5. 5. Patients having history of malignancy within the last 5 years.
  6. 6. Patient having prior or continuing diagnosis of serious cardiovascular disease.

Contacts and Locations

Study Contact

RemeGen
CONTACT
800-910-6542
RC18_MGstudy@remegenbio.com

Study Locations (Sites)

Boca Raton, Florida Site
Boca Raton, Florida, 33487
United States
Miami, Florida Site
Miami, Florida, 33155
United States
Port Charlotte, Florida Site
Port Charlotte, Florida, 33952
United States

Collaborators and Investigators

Sponsor: RemeGen Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-17
Study Completion Date2027-10

Study Record Updates

Study Start Date2024-07-17
Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

  • Myasthenia Gravis
  • gMG

Additional Relevant MeSH Terms

  • Generalized Myasthenia Gravis