Generalized Myasthenia GravisPhase 2NCT07622342
A Phase II Study of SHR-2173 Injection in Patients With Myasthenia Gravis
A Phase 2 study testing SHR-2173 injection in people with Generalized Myasthenia Gravis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 2 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Generalized Myasthenia Gravis
- What is being tested?
- SHR-2173 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 28 Aug 2026to Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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);
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- 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;
- Live/attenuated live vaccine within 4 weeks prior to randomization, or planned vaccination during the study.
- A history of malignancy within 5 years prior to screening;
- Infection-related medical history and examinations:
- A history of herpes zoster meeting any of the following: 1) A history of disseminated herpes zoster, herpes zoster encephalitis, or ocular herpes zoster involving the retina; 2) Recurrent herpes zoster with 2 or more episodes within 2 years; 3) Herpes zoster infection not fully resolved within 12 weeks prior to screening;
- A history of tuberculosis (TB) or latent TB infection;
- A known history of primary immunodeficiency, splenectomy, or any underlying condition predisposing to infection;
- A history of recurrent infections requiring hospitalization and intravenous antibiotics;
- Any infection requiring hospitalization and/or intravenous antimicrobial therapy within 8 weeks prior to randomization, or any infection requiring oral antimicrobial therapy within 2 weeks prior to randomization;
- Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody, treponemal pallidum antibody, or human immunodeficiency virus (HIV) antibody; for patients with HBsAg-negative but hepatitis B core antibody (HBcAb)-positive, regardless of the status of hepatitis B surface antibody (HBsAb), HBV-DNA testing is required to confirm their condition, with HBV-DNA-positive patients excluded and HBV-DNA-negative patients eligible to participate in the study.
- General situation:
- Pregnant or lactating females;
- A history of alcohol abuse or illicit drug abuse within 1 year prior to screening;
- A history of allergic diathesis, or known hypersensitivity/intolerance to any component of the investigational product;
- Major surgery within 3 months prior to the screening, or planned major surgery during the study;
- Any condition that, in the investigator's judgment, may affect evaluation of study drug safety and efficacy, or any other condition that renders the subject ineligible.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Huan Yang
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Chongbo Zhao
About this study
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of SHR-2173 in Patients With Generalized Myasthenia Gravis
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
- Being tested
- SHR-2173 injection, Placebo
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-2173 injectionDrug
SHR-2173 injection；High dose
SHR-2173 injectionDrug
SHR-2173 injection；Low dose
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: SHR-2173 injection | Experimental | Not described Receives: Drug: SHR-2173 injection |
| Treatment group B: SHR-2173 injection | Experimental | Not described Receives: Drug: SHR-2173 injection |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in MG-ADL total score
Measured: at Week 24
Secondary outcomes (16)
Change from baseline in Quantitative Myasthenia Gravis (QMG) score
Measured: at Week 24
Change from baseline in Myasthenia Gravis Composite (MGC) total score
Measured: at Week 24
Change from baseline in MG-ADL domain scores (ocular, bulbar, respiratory, limb)
Measured: at Week 24
Change from baseline in QMG domain scores (ocular, bulbar, respiratory, limb)
Measured: at Week 24
Proportion of participants with ≥3-point reduction from baseline in MG-ADL total score
Measured: at Week 24
Proportion of participants with ≥50% reduction from baseline in MG-ADL total score
Measured: at Week 24
Proportion of participants with ≥5-point reduction from baseline in QMG score
Measured: at Week 24
Proportion of participants achieving Minimal Symptom Expression (MSE; MG-ADL total score 0 or 1) at Week 24
Measured: at Week 24
Change from baseline in Myasthenia Gravis Quality of Life 15-item revised (MG-QoL15r) total score
Measured: at Week 24
Change from baseline in Neuro-QoL Fatigue subscale score
Measured: at Week 24
Change from baseline in European Quality of Life 5-Dimensions 5-Levels (EQ-5D-5L) index score
Measured: at Week 24
Proportion of participants without rescue therapy
Measured: through Week 24
Incidence, severity grading, and drug-relatedness of adverse events (AEs)
Measured: through Week 24
Incidence, severity grading, and drug-relatedness of serious adverse events (SAEs)
Measured: through Week 24
Incidence, severity grading, and drug-relatedness of adverse events of special interest (AESIs)
Measured: through Week 24
Change from baseline in C-SSRS
Measured: through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start28 Aug 2026
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Myasthenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622342
- Sponsor's protocol ID
- SHR-2173-206
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided