NCT05332210CompletedPhase 3
Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis
A Long-term Open-label Extension Study to Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
The primary study objective is to evaluate medium- and long-term safety of HBM9161 in combination with background treatment for gMG patients through the observation on adverse events and laboratory abnormalities during study period.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 111 (actual)
- First submitted
- 6 Apr 2022
- Start date
- 30 Jun 2022
- Primary completion date
- 26 Apr 2024
- Lead sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.
- Diseases
- Myasthenia gravis
- NCT number
- NCT05332210
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 111
- From 30 Jun 2022 to the primary completion date, 26 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had received any other clinical study drug since the administration of the study drug in the 9161.3 Phase 3 study.
Other
- Females who are pregnant or lactating or planning to become pregnant during the study period, or females of childbearing potential who are not using an effective method of contraception.
Who the study is looking for
- Completed the HBM9161.3 Phase 3 study
- Signed written informed consent.
- Suitable for continued treatment with HBM9161 as judged by the investigator.
- Female patients of childbearing potential and male patients with female partners of childbearing potential can participate in this study, but reliable contraceptive measures must be taken (such as physical barrier contraception (patients and their partners), contraceptive pills or patches, spermicide and barrier or intrauterine device). Up to 60 days after the last dose.
- A negative urine pregnancy at baseline must be observed for women of childbearing age.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.