Study of Telitacicept in Generalized Myasthenia Gravis

Sponsor
RemeGen Co., Ltd.
Study ID
NCT05737160
Phase
PHASE3
Status
Completed

Conditions

  • Myasthenia Gravis, Generalized

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Telitacicept — BIOLOGICAL
    Administered as an SC infusion
  • Placebo — DRUG
    Administered as an SC infusion

Study Details

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

Key Dates

Start date
Mar 28, 2023
Status verified
Oct 2024
Primary completion
Nov 26, 2024
Completion
Dec 12, 2024

Study Design

Enrollment
114 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Telitacicept
    Participants will receive subcutaneous Telitacicept 240 mg once a week for a total of 48 doses in addition to MG SoC.
  • Placebo Comparator: Placebo
    Participants will receive subcutaneous placebo once a week for a total of 24 doses (part A) and then weekly subcutaneous Telitacicept 240 mg for 24 doses (part B) in addition to MG SoC.

Primary Outcome Measure

Change from baseline in MG-ADL [ Time Frame: Week 24 ]

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