Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis

Harbour BioMed

Status and phase: Enrolling; Phase 3

Conditions: Myasthenia Gravis

Treatments: Drug: HBM9161 Injection (680mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05332210

9161.7

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Completed the HBM9161.3 Phase 3 study
2. Signed written informed consent.
3. Suitable for continued treatment with HBM9161 as judged by the investigator.
4. 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.
5. A negative urine pregnancy at baseline must be observed for women of childbearing age.

Exclusion criteria

1. Had received any other clinical study drug since the administration of the study drug in the 9161.3 Phase 3 study.
2. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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144 participants in 1 patient group

HBM9161 Drug Product (680mg)

Experimental group

Description:

HBM9161 680mg: subcutaneous injection, 6 times per treatment cycle, once a week; the second cycle of treatment may start 4 weeks after the last dose of the previous treatment cycle; if the disease state is still stable 4 weeks after the last dose, the observation can be continued until the disease activity is aggravated (improvement of MG-ADL \< 3 points compared with the previous treatment cycle), and the next treatment cycle can start. The dose may be reduced to 340 per investigator's discretion. Return to the dose of 680 mg is not permitted after a dose reduction is made.

Treatment:

Drug: HBM9161 Injection (680mg)