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

NCT05332210 | Completed Phase 3

• 1 other identifier: 9161.7
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of AEs during the study

  Incidence of AEs

  during the study，up to 24 weeks

Secondary Outcomes (5)

• Proportion of patients with sustained improvement

  during each treatment cycle (5-week treatment period + 4-week observation period, from the first dose of the cycle to Day 64 of the cycle)

• During the 24-week study, proportion of time that MG-ADL improved from baseline by 3 or more points

  during the study，up to 24 weeks

• Proportion of time remained in Minimal Symptom Expression

  during the study，up to 24 weeks

• Improvement of patients' quality of life

  during the study，up to 24 weeks

• Incidence and duration of serum anti-HBM9161 antibodies and neutralizing antibodies

  during the study，up to 24 weeks

Study Arms (1)

HBM9161 Drug Product (680mg)

EXPERIMENTAL

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.

Drug: HBM9161 Injection (680mg)

Interventions

HBM9161 Injection (680mg) DRUG

HBM9161 Injection

HBM9161 Drug Product (680mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Harbour BioMed (Guangzhou) Co. Ltd.: lead

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

HBM9161

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 18, 2022
• Study Start: June 30, 2022
• Primary Completion: April 26, 2024
• Study Completion: April 26, 2024
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

CN (1)