A Phase II Study of SHR-2173 Injection in Patients With Myasthenia Gravis (NCT07622342) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase II Study of SHR-2173 Injection in Patients With Myasthenia Gravis
China60 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
Exclusion criteria
. 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: