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

NCT ID: NCT05332210

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2023-12-30

Brief Summary

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.

Conditions

Myasthenia Gravis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HBM9161 Drug Product (680mg)

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.

Group Type: EXPERIMENTAL

HBM9161 Injection (680mg)

Intervention Type: DRUG

HBM9161 Injection

Interventions

HBM9161 Injection (680mg)

HBM9161 Injection

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harbour BioMed (Guangzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chongbo Zhao

Role: CONTACT

zhao_chongbo@fudan.edu.cn

+86 13701822316

Facility Contacts

Chongbo Zhao

Role: primary

zhao_chongbo@fudan.edu.cn

+8613701822316

Other Identifiers

9161.7

Identifier Type: -

Identifier Source: org_study_id