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

NCT07622342 | Not Yet Recruiting Phase 2

• 1 other identifier: SHR-2173-206
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Generalized Myasthenia Gravis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in MG-ADL total score

  at Week 24

Secondary Outcomes (16)

• Change from baseline in Quantitative Myasthenia Gravis (QMG) score

  at Week 24

• Change from baseline in Myasthenia Gravis Composite (MGC) total score

  at Week 24

• Change from baseline in MG-ADL domain scores (ocular, bulbar, respiratory, limb)

  at Week 24

• Change from baseline in QMG domain scores (ocular, bulbar, respiratory, limb)

  at Week 24

• Proportion of participants with ≥3-point reduction from baseline in MG-ADL total score

  at Week 24

Study Arms (3)

Treatment group A: SHR-2173 injection

EXPERIMENTAL

Drug: SHR-2173 injection

Treatment group B: SHR-2173 injection

EXPERIMENTAL

Drug: SHR-2173 injection

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SHR-2173 injection DRUG

SHR-2173 injection；High dose

Treatment group A: SHR-2173 injection

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants aged 18-75 years, confirmed diagnosis of generalized myasthenia gravis (gMG) (Myasthenia Gravis Foundation of America \[MGFA\] class II-IV).
• Positive for anti-AChR antibody or anti-MuSK antibody.
• MG-ADL total score ≥5 at screening and baseline, with \>50% of the score attributable to non-ocular items.
• QMG score ≥11 at screening and baseline.
• Maintenance on stable standard of care (SOC) therapy.
• No contraindication to at least one rescue therapy: IVIg or PLEX.
• Provided written informed consent (ICF) after full understanding of the study content, procedures, and potential adverse reactions.
• Female subjects with fertility or male participants whose partners are women of childbearing age must avoid donating sperm/eggs from the date of signing the ICF until 12 weeks after the last study medication, and agree to take contraceptive measures as specified in the protocol

You may not qualify if:

• Presence of any of the following medical histories or comorbidities:
• Any untreated thymic epithelial tumor, mediastinal germ cell tumor, or other malignant mediastinal mass; or any thymic cyst or other mass requiring immediate intervention per investigator judgment;
• Previous history of thymic tumor not meeting protocol requirements;
• Myasthenic crisis (MGFA Class V) within 3 months prior to randomization;
• Any known disease other than gMG that may interfere with study procedures and assessments;
• A history of progressive multifocal leukoencephalopathy (PML);
• A history of body irradiation or organ transplantation.
• Use of any of the following drugs/treatments or participation in a clinical study:
• Prior treatment with CAR-T or other cellular therapy, or T-cell engager (TCE) therapy;
• Anti-CD20 monoclonal antibody within 6 months prior to randomization; other B-cell or plasma cell-depleting therapy within 6-12 months prior to randomization;
• Alkylating agent within 12 weeks prior to randomization;
• Any biologic for MG treatment within 12 weeks prior to randomization;
• Neonatal Fc receptor antagonist therapy within 8 weeks prior to randomization;
• Janus kinase (JAK), Bruton tyrosine kinase (BTK), or tyrosine kinase 2 (TYK2) inhibitor within 12 weeks prior to randomization;
• IVIg, subcutaneous immunoglobulin, or PLEX therapy within 4 weeks prior to randomization;

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (2)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Kunming Li

CONTACT

0518-82342973; kunming.li@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

CN (2)