Myasthenia GravisPhase 3MGNCT05039190
Evaluate the Efficacy and Safety of HBM9161(HL161)Subcutaneous Injection in Patients With Generalized MG Patients
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
Primary study objective: To confirm the efficacy of HBM9161 subcutaneous injection for the treatment of gMG in Chinese patients Read more about this study
- Who is it for?
- Ages 18 to 99 years
- 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?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2021to 14 Jan 2023
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent form (ICF).
- Male or female ≥ 18 years of age at the screening visit.
- Female subjects must meet the following conditions to participate in this study:
- Not of childbearing potential (ie, physiologically incapable of becoming pregnant, including women who have been postmenopausal for 2 or more years);
- Of potential childbearing potential, have a negative serum pregnancy test result at the screening visit, and agree to adhere to one of the following acceptable effective methods of contraception (ie, per approved product label insert and physician instructions) consistently and correctly during the study, until 60 days after the last dose:
- Total abstinence (based on subject preference and previous lifestyle); or ii. Implantation of a levonorgestrel implant at least 1 month prior to study drug administration, but no longer than 3 years; or iii. Injection of a progestogen at least 1 month prior to study drug administration; or iv. A cycle of oral contraceptives (combined contraceptives or progestin-only) for at least 1 month prior to study drug administration; or v. Double contraception: condom or cervical cap (diaphragm or cervical cap) plus spermicide (foam/gel/cream/suppository); or vi. An intrauterine device, implanted by a qualified physician; or vii. Estrogen vaginal ring; or viii. Contraceptive patch.
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- Male subjects must use effective contraceptive methods or have their heterosexual partners use effective contraceptive methods during their participation in this clinical trial.
- Meets MGFA myasthenia gravis clinical classification IIa-IVa (includes types IIa, IIb, IIIa, IIIb, and IVa) at the screening visit and at the baseline visit.
- Screening and baseline MG-ADL score ≥ 5, and < 50% of them is from ocular muscle.At least one stable background MG treatment at randomization.Positive or negative AchR-Ab/MUSK-Ab at the screening visit and meets at least 1 of the following 3 criteria:
- Repeated electrical stimulation indicates neuromuscular junction transmission disorder (including medical history record);
- Positive Tensilon test or neostigmine test (including medical history record);
- The patient's MG symptoms improve after treatment with oral cholinesterase inhibitors at the judge of the physician.
- Results from clinical laboratory tests at screening must be acceptable to the investigator.
Who cannot join
- Has a serious illness or condition other than myasthenia gravis that, in the judgment of the investigator, would put the subject at risk because of participation in the study, or that would affect the results of the study and the subject's ability to participate in the 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.
- Subjects with severe myasthenia gravis (such as Type IVb or V) who are judged by the investigator to be inappropriate for this study (e.g., expected to require artificial assisted ventilation during the study).
- Thymectomy performed < 12 months prior to screening.
- Presence of other autoimmune diseases (such as uncontrolled thyroid disease, severe rheumatoid arthritis, etc.) that may affect the efficacy assessment of the study drug or affect participation in this study.
- Has received a vaccine injection (including the COVID-19 vaccine) 4 weeks prior to the Screening Visit or is scheduled to receive a vaccine injection during the study.
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- Any active infection at the Screening Visit or serious infection requiring treatment with intravenous anti-infective drugs or hospitalization within 8 weeks before the Screening Visit.
- Current or past 1 year alcohol or drug dependence/abuse, except nicotine and coffee.
- Subjects who are allergic to the trial drug or its components; or history of clinically significant allergic disease (including drug allergies, anaphylaxis) that, in the opinion of the investigator, affects the subject's participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Seamless and Group Sequential Phase 2/3 Study to Evaluate the Efficacy and Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis
Primary study objective: To confirm the efficacy of HBM9161 subcutaneous injection for the treatment of gMG in Chinese patients
Read the detailed description
This is the phase 3 part of a multi-center, randomized, double-blind, placebo-controlled, group sequential designed, seamless phase 2/3 study to confirm the efficacy and safety of HBM9161 (HL161) subcutaneous injection for the treatment of gMG in patients with generalized myasthenia gravis.
Study drug will be administrated by cycle. Each cycle consists of 5-week treatment period, followed by a 4-week observation period (9 weeks in total). During the 5-week treatment period, subjects will receive 6 doses of study drug (HBM9161 680 mg or matching placebo) by subcutaneous injection, once a week (QW). After the 5-week treatment period, subjects will be followed up weekly to assess efficacy and safety. After the completion of first treatment cycle, subjects may start the second cycle of treatment if re-treatment criteria are met. Otherwise, subjects will be followed up weekly until they are eligible for the second cycle or the end of the study, whichever is earlier.
- Conditions
- Myasthenia Gravis
- Being tested
- HBM9161 Injection (680mg), Placebo
- Keywords
- MG
- 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
PlaceboDrug
Placebo Injection
| Study group | Role | What they receive |
|---|---|---|
| Experimental: HBM9161 (680mg ) | Active comparator | HBM9161 680mg; First treatment period: Subcutaneous injection, QW for 6 doses; Second treatment period: Subcutaneous injection, QW for 6 doses Receives: Drug: HBM9161 Injection (680mg) |
| Placebo Comparator: Placebo | Placebo comparator | Placebo; First treatment period: Subcutaneous injection, QW for 6 doses; Second treatment period: Subcutaneous injection, QW for 6 doses Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
In the first treatment cycle, percentage of patients with sustained improvement based on Myasthenia Gravis Activities of Daily Living Scale (MG-ADL), among serum AChR-Ab- or MuSK-Ab-positive subjects
Definition of sustained improvement based on MG-ADL: during the treatment cycle (5-week treatment period plus 4-week observation period), a reduction of ≥ 3 points from the baseline of MG-ADL score for 4 consecutive weekly MG-ADL assessments
Measured: baseline to Day 64
Secondary outcomes (6)
In the first treatment cycle, percentage of patients with sustained improvement based on MG-ADL, among all study subjects, regardless of , regardless of AChR-Ab and MuSK-Ab serologic status
Measured: Baseline to Day 64
In the first treatment cycle, percentage of subjects with sustained improvement based on Quantitative Myasthenia Gravis Scale (QMG), among serum AChR-Ab- or MuSK-Ab-positive subjects [ Time Frame: baseline to Day 64 ]
Definition of sustained improvement based on QMG: a reduction of ≥ 3 points from the baseline of QMG score for 4 consecutive weekly QMG assessments during the treatment cycle (5-week treatment period plus 4-week observation period)
Measured: Baseline to Day 64
During the 24-study period, the proportion of weekly MG-ADL assessments that are improved ≥ 3 points from baseline among serum AChR-Ab- or MuSK-Ab-positive subjects
Measured: baseline to Day 64
In the first treatment cycle, percentage of serum AChR-Ab- or MuSK-Ab-positive subjects who meet the minimal symptom manifestation (MSE, defined as MG-ADL being 0 or 1) criterion at any visit
Measured: baseline to Day 64
Within the first 2 weeks of the first treatment cycle, percentage of AChR-Ab- or MuSK-Ab-positive subjects whose MG-ADL improved by ≥3 points from baseline
Measured: baseline to Day 64
Within the second treatment cycle, percentage of patients with sustained improvement based on MG-ADL, among serum AChR-Ab- or MuSK-Ab-positive subjects during the second 9-week treatment cycle
Measured: baseline to Day 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start25 Sep 2021
- Primary completion14 Jan 2023
- Study completion14 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- To confirm the efficacy of HBM9161 subcutaneous injection for the treatment of gMG in Chinese patientsTreatment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chongbo Zhao, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039190
- Sponsor's protocol ID
- 9161.3 ph3
- Acronym
- MG
- Status last verified
- Mar 2023
- First submitted
- 29 Aug 2021
- Last updated
- 8 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Z, Ke Q, Xi J, Yue Y, Guan Y, Duan R, Xue Q, Jiang H, Xiao F, Yang H, Chang T, Zou Z, Li H, Tan S, Xiao H, Zhou H, Zhang H, Meng Q, Li W, Li W, Guo J, Zhang Y, Li Z, Tu J, Shi J, Li W, Zhao C, Zhao S, Zong C, Deng H, Bu B. Rapid Serum IgG Reduction as a Potential Indicator of Short-Term Clinical Improvement in AChR-Ab-Positive Generalized Myasthenia Gravis: A Post Hoc Analysis of a Phase III Batoclimab Trial. Neurol Ther. 2026 Oct 13. doi: 10.1007/s40120-026-01019-6. Online ahead of print.
PubMed 42867600Yan C, Yue Y, Guan Y, Bu B, Ke Q, Duan R, Deng H, Xue Q, Jiang H, Xiao F, Yang H, Chang T, Zou Z, Li H, Tan S, Xiao H, Zhou H, Zhang H, Meng Q, Li W, Li W, Guo J, Zhang Y, Li Z, Tu J, Shi J, Li W, Lee M, Chen Y, Tao X, Zhao S, Li P, Zhao C; Batoclimab Study Team. Batoclimab vs Placebo for Generalized Myasthenia Gravis: A Randomized Clinical Trial. JAMA Neurol. 2024 Mar 4;81(4):336-45. doi: 10.1001/jamaneurol.2024.0044. Online ahead of print.
PubMed 38436998
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Seamless and Group Sequential Phase 2/3 Study to Evaluate the Efficacy and Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT05039190
- Acronym / sponsor ID
- MG / 9161.3 ph3
- Conditions
- Myasthenia Gravis
- Keywords
- MG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2021 (actual)
- Primary completion
- 14 Jan 2023 (actual)
- Study completion
- 14 Jan 2023 (actual)
- First posted
- 9 Sep 2021 (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.
Primary study objective: To confirm the efficacy of HBM9161 subcutaneous injection for the treatment of gMG in Chinese patients
Detailed description
This is the phase 3 part of a multi-center, randomized, double-blind, placebo-controlled, group sequential designed, seamless phase 2/3 study to confirm the efficacy and safety of HBM9161 (HL161) subcutaneous injection for the treatment of gMG in patients with generalized myasthenia gravis.
Study drug will be administrated by cycle. Each cycle consists of 5-week treatment period, followed by a 4-week observation period (9 weeks in total). During the 5-week treatment period, subjects will receive 6 doses of study drug (HBM9161 680 mg or matching placebo) by subcutaneous injection, once a week (QW). After the 5-week treatment period, subjects will be followed up weekly to assess efficacy and safety. After the completion of first treatment cycle, subjects may start the second cycle of treatment if re-treatment criteria are met. Otherwise, subjects will be followed up weekly until they are eligible for the second cycle or the end of the study, whichever is earlier.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- To confirm the efficacy of HBM9161 subcutaneous injection for the treatment of gMG in Chinese patientsTreatment
| Arm | Type | Receives |
|---|---|---|
| Experimental: HBM9161 (680mg ) | Active comparator | Drug: HBM9161 Injection (680mg)HBM9161 680mg; First treatment period: Subcutaneous injection, QW for 6 doses; Second treatment period: Subcutaneous injection, QW for 6 doses |
| Placebo Comparator: Placebo | Placebo comparator | Drug: PlaceboPlacebo; First treatment period: Subcutaneous injection, QW for 6 doses; Second treatment period: Subcutaneous injection, QW for 6 doses |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed written informed consent form (ICF).
- Male or female ≥ 18 years of age at the screening visit.
- Female subjects must meet the following conditions to participate in this study:
- Male subjects must use effective contraceptive methods or have their heterosexual partners use effective contraceptive methods during their participation in this clinical trial.
- Meets MGFA myasthenia gravis clinical classification IIa-IVa (includes types IIa, IIb, IIIa, IIIb, and IVa) at the screening visit and at the baseline visit.
Key exclusion criteria (9 listed)
- Has a serious illness or condition other than myasthenia gravis that, in the judgment of the investigator, would put the subject at risk because of participation in the study, or that would affect the results of the study and the subject's ability to participate in the 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.
- Subjects with severe myasthenia gravis (such as Type IVb or V) who are judged by the investigator to be inappropriate for this study (e.g., expected to require artificial assisted ventilation during the study).
- Thymectomy performed < 12 months prior to screening.
- Presence of other autoimmune diseases (such as uncontrolled thyroid disease, severe rheumatoid arthritis, etc.) that may affect the efficacy assessment of the study drug or affect participation in this study.
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 | Experimental: HBM9161 (680mg ) |
| PlaceboPlacebo Injection | Drug | Placebo Comparator: Placebo |
Primary outcome
In the first treatment cycle, percentage of patients with sustained improvement based on Myasthenia Gravis Activities of Daily Living Scale (MG-ADL), among serum AChR-Ab- or MuSK-Ab-positive subjects
Time frame: baseline to Day 64
Definition of sustained improvement based on MG-ADL: during the treatment cycle (5-week treatment period plus 4-week observation period), a reduction of ≥ 3 points from the baseline of MG-ADL score for 4 consecutive weekly MG-ADL assessments
6 secondary outcomes
In the first treatment cycle, percentage of patients with sustained improvement based on MG-ADL, among all study subjects, regardless of , regardless of AChR-Ab and MuSK-Ab serologic status
Time frame: Baseline to Day 64
In the first treatment cycle, percentage of subjects with sustained improvement based on Quantitative Myasthenia Gravis Scale (QMG), among serum AChR-Ab- or MuSK-Ab-positive subjects [ Time Frame: baseline to Day 64 ]
Time frame: Baseline to Day 64
During the 24-study period, the proportion of weekly MG-ADL assessments that are improved ≥ 3 points from baseline among serum AChR-Ab- or MuSK-Ab-positive subjects
Time frame: baseline to Day 64
In the first treatment cycle, percentage of serum AChR-Ab- or MuSK-Ab-positive subjects who meet the minimal symptom manifestation (MSE, defined as MG-ADL being 0 or 1) criterion at any visit
Time frame: baseline to Day 64
Within the first 2 weeks of the first treatment cycle, percentage of AChR-Ab- or MuSK-Ab-positive subjects whose MG-ADL improved by ≥3 points from baseline
Time frame: baseline to Day 64
Within the second treatment cycle, percentage of patients with sustained improvement based on MG-ADL, among serum AChR-Ab- or MuSK-Ab-positive subjects during the second 9-week treatment cycle
Time frame: baseline to Day 64
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 8 Mar 2023.
- Derived from this study: PubMed 42867600Li Z, Ke Q, Xi J, Yue Y, Guan Y, Duan R, Xue Q, Jiang H, Xiao F, Yang H, Chang T, Zou Z, Li H, Tan S, Xiao H, Zhou H, Zhang H, Meng Q, Li W, Li W, Guo J, Zhang Y, Li Z, Tu J, Shi J, Li W, Zhao C, Zhao S, Zong C, Deng H, Bu B. Rapid Serum IgG Reduction as a Potential Indicator of Short-Term Clinical Improvement in AChR-Ab-Positive Generalized Myasthenia Gravis: A Post Hoc Analysis of a Phase III Batoclimab Trial. Neurol Ther. 2026 Oct 13. doi: 10.1007/s40120-026-01019-6. Online ahead of print.
- Derived from this study: PubMed 38436998Yan C, Yue Y, Guan Y, Bu B, Ke Q, Duan R, Deng H, Xue Q, Jiang H, Xiao F, Yang H, Chang T, Zou Z, Li H, Tan S, Xiao H, Zhou H, Zhang H, Meng Q, Li W, Li W, Guo J, Zhang Y, Li Z, Tu J, Shi J, Li W, Lee M, Chen Y, Tao X, Zhao S, Li P, Zhao C; Batoclimab Study Team. Batoclimab vs Placebo for Generalized Myasthenia Gravis: A Randomized Clinical Trial. JAMA Neurol. 2024 Mar 4;81(4):336-45. doi: 10.1001/jamaneurol.2024.0044. Online ahead of print.
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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.
Chongbo Zhao principal investigator
Huashan Hospital
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 13 inclusion and 9 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 8 Mar 2023. 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. Some participants in this study may receive a placebo. 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?
In the first treatment cycle, percentage of patients with sustained improvement based on Myasthenia Gravis Activities of Daily Living Scale (MG-ADL), among serum AChR-Ab- or MuSK-Ab-positive subjects (time frame: baseline to Day 64). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05039190, which also lists 2 linked publications.
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 8 Mar 2023.