Myasthenia GravisPhase 3NCT05332210
Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis
A Phase 3 study testing HBM9161 Injection (680mg) in people with Myasthenia Gravis, run by Harbour BioMed (Guangzhou) Co. Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- HBM9161 Injection (680mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2022to 26 Apr 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Long-term Open-label Extension Study to 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.
- Conditions
- Myasthenia Gravis
- Being tested
- HBM9161 Injection (680mg)
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBM9161 Injection (680mg)Drug
HBM9161 Injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: HBM9161 Injection (680mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs during the study
Incidence of AEs
Measured: during the study，up to 24 weeks
Secondary outcomes (5)
Proportion of patients with sustained improvement
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
Measured: 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
Measured: during the study，up to 24 weeks
Proportion of time remained in Minimal Symptom Expression
from baseline to Week 24, percentage of time MG-ADL score being 0 or 1
Measured: during the study，up to 24 weeks
Improvement of patients' quality of life
Improvement of patients' quality of life
Measured: during the study，up to 24 weeks
Incidence and duration of serum anti-HBM9161 antibodies and neutralizing antibodies
Incidence and duration of serum anti-HBM9161 antibodies and neutralizing antibodies
Measured: during the study，up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start30 Jun 2022
- Primary completion26 Apr 2024
- Study completion26 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332210
- Sponsor's protocol ID
- 9161.7
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2022
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Open-label Extension Study to Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT05332210
- Acronym / sponsor ID
- 9161.7
- Conditions
- Myasthenia Gravis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBM9161 Drug Product (680mg) | Experimental | Drug: HBM9161 Injection (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBM9161 Injection (680mg)HBM9161 Injection | Drug | HBM9161 Drug Product (680mg) |
Primary outcome
Incidence of AEs during the study
Time frame: during the study，up to 24 weeks
Incidence of AEs
5 secondary outcomes
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)
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
Proportion of time remained in Minimal Symptom Expression
Time frame: during the study，up to 24 weeks
Improvement of patients' quality of life
Time frame: during the study，up to 24 weeks
Incidence and duration of serum anti-HBM9161 antibodies and neutralizing antibodies
Time frame: during the study，up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HBM9161 Injection (680mg) in people with Myasthenia Gravis, run by Harbour BioMed (Guangzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs during the study (time frame: during the study，up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.