A Phase II Study of SHR-2173 Injection in Patients With Myasthenia Gravis

Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Study ID
NCT07622342
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Generalized Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR-2173 injection — DRUG
    SHR-2173 injection；High dose
  • SHR-2173 injection — DRUG
    SHR-2173 injection；Low dose
  • Placebo — DRUG
    Placebo

Study Details

This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of SHR-2173 compared to placebo as an add-on therapy to standard of care (SOC) for the treatment of generalized myasthenia gravis (gMG). The study consists of a 4-week screening period, a 24-week treatment period, and a 12-week safety follow-up period.

Key Dates

First listed
Jun 3, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group A: SHR-2173 injection
  • Experimental: Treatment group B: SHR-2173 injection
  • Placebo Comparator: Placebo

Primary Outcome Measure

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

Central Contacts

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