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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
Are there results?
Not yet: the study is under way

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.

Kunming Li contact

0518-82342973

kunming.li@hengrui.com

China2 sites, 2 recruiting

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

    Huan Yang

    Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040

    Chongbo Zhao

    Recruiting

Other trials in China

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.

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 groups in NCT07622342
Study groupRoleWhat they receive
Treatment group A: SHR-2173 injectionExperimentalNot described
Receives: Drug: SHR-2173 injection
Treatment group B: SHR-2173 injectionExperimentalNot described
Receives: Drug: SHR-2173 injection
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in MG-ADL total score

    Measured: at Week 24

Secondary outcomes (16)

  1. Change from baseline in Quantitative Myasthenia Gravis (QMG) score

    Measured: at Week 24

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

    Measured: at Week 24

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

    Measured: at Week 24

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

    Measured: at Week 24

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

    Measured: at Week 24

  6. Proportion of participants with ≥50% reduction from baseline in MG-ADL total score

    Measured: at Week 24

  7. Proportion of participants with ≥5-point reduction from baseline in QMG score

    Measured: at Week 24

  8. Proportion of participants achieving Minimal Symptom Expression (MSE; MG-ADL total score 0 or 1) at Week 24

    Measured: at Week 24

  9. Change from baseline in Myasthenia Gravis Quality of Life 15-item revised (MG-QoL15r) total score

    Measured: at Week 24

  10. Change from baseline in Neuro-QoL Fatigue subscale score

    Measured: at Week 24

  11. Change from baseline in European Quality of Life 5-Dimensions 5-Levels (EQ-5D-5L) index score

    Measured: at Week 24

  12. Proportion of participants without rescue therapy

    Measured: through Week 24

  13. Incidence, severity grading, and drug-relatedness of adverse events (AEs)

    Measured: through Week 24

  14. Incidence, severity grading, and drug-relatedness of serious adverse events (SAEs)

    Measured: through Week 24

  15. Incidence, severity grading, and drug-relatedness of adverse events of special interest (AESIs)

    Measured: through Week 24

  16. 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.

  1. First posted3 Jun 2026
  2. Study start28 Aug 2026
  3. Primary completionSep 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kunming Li (0518-82342973, kunming.li@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in MG-ADL total score (time frame: at Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07622342.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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