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OpenTrials
Completed

NCT Number: NCT05332210

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

HBM9161 Injection (680mg)

Drug

HBM9161 Injection

Primary outcomes

  1. Incidence of AEs during the study

    Time frame: during the study，up to 24 weeks

    Incidence of AEs

Secondary outcomes

  1. Proportion of patients with sustained improvement

    Time frame: 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)

    Sustained reduction defined as MG-ADL score improved by ≥ 3 points from baseline for at least 4 consecutive weeks during the 9-week treatment cycle

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

    Time frame: during the study，up to 24 weeks

  3. Proportion of time remained in Minimal Symptom Expression

    Time frame: during the study，up to 24 weeks

    from baseline to Week 24, percentage of time MG-ADL score being 0 or 1

  4. Improvement of patients' quality of life

    Time frame: during the study，up to 24 weeks

    Improvement of patients' quality of life

  5. Incidence and duration of serum anti-HBM9161 antibodies and neutralizing antibodies

    Time frame: during the study，up to 24 weeks

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

Sponsors and collaborators

Lead sponsor

Harbour BioMed (Guangzhou) Co. Ltd.

Industry

Registry information

Official study title

A Long-term Open-label Extension Study to Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2022
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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