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

NCT07622342 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-06-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

SHR-2173 injection

SHR-2173 injection；High dose

DRUG

SHR-2173 injection

SHR-2173 injection；Low dose

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Guangdong Hengrui Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07622342 on ClinicalTrials.gov