Myasthenia GravisPhase 2NCT04346888
A Study to Evaluate the Efficacy, Safety and PD and PK of HBM9161 in MG Patients
A Phase 2 study testing HBM9161 Injection (680mg and 340 mg) and HBM9161 Injection (340 mg) in people with Myasthenia Gravis, run by Harbour BioMed (Guangzhou) Co. Ltd. at 1 site in China.
Trial summary
Primary Objectives: To investigate the efficacy of HBM9161 in patients with attack of MG in China 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 and 340 mg) and HBM9161 Injection (340 mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2020to 24 Aug 2021
- Phase
- Phase 2
- 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 Informed Consent Form.
- Male or female ≥ 18 years of age.
- A female participant is eligible to participate if she is of:
- Non-childbearing potential (physically infertile, including women who have been menopausal for 2 years or more);
- Childbearing potential, negative serum pregnancy test results at screening visits, and agree to consistently use acceptable and effective contraceptive methods until 14 days after the final visit.
- A male participant must take effective contraception during this clinical trial or their heterosexual partner must take effective contraception.
Show all 13Show fewer
- 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 ≥ 6, and < 50% of them is from ocular muscle.
- Stable background MG treatments at randomization.
- Positive serologic test for AChR-Ab or MUSK-Ab at the screening visit and at least 1 of the following:
- History of abnormal neuromuscular transmission test demonstrated by sign-fiber-electromyography or repetitive nerve stimulation OR
- History of positive edrophonium chloride test OR
- Participant has demonstrated improvement in MG signs on oral cholinesterase inhibitors as assessed by the treating physician.
Who cannot join
- Use of rituximab, belimumab, eculizumab or any monoclonal antibody/Fc-fusion biologic for immunomodulation within 6 months prior to screening.
- Immunoglobulins given by SC, IV(IVIG), or intramuscular route, or plasmapheresis/plasma exchange (PE) within 4 weeks before screening.
- Thymectomy performed < 12 months prior to screening.
- Total IgG level <6g/L (at screening).
- Participant has any laboratory abnormality (at screening) that, in the opinion of the investigator, is clinically significant, has not resolved at baseline, and could jeopardize or would compromise the participant's ability to participate in this study.
- Have known autoimmune disease other than MG that would interfere with the course and conduct of the study (such as uncontrolled thyroid disease).
- Have an active infection, a recent serious infection (i.e., requiring injectable antimicrobial therapy or hospitalization) within the 8 weeks prior to screening.
- History of or known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or Mycobacterium tuberculosis. Participants must have negative test results for HBV surface antigen, HBV core antibody, HCV antibody, HIV 1 and 2 antibodies and a negative TB test at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacodynamic and Pharmacokinetic of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis
Primary Objectives: To investigate the efficacy of HBM9161 in patients with attack of MG in China
Read the detailed description
This is a multicenter, randomized, double-blind and placebo-controlled study. The investigational drug is HBM9161 injection, and the indication is MG.
The subjects will be randomized to three dose groups (340mg, 680mg and placebo) for a 6 weeks' double-blind treatment period followed by an open-label extension treatment period. The study will investigate the safety, efficacy and pharmacodynamic and pharmacokinetic of HBM9161 in patients with attack of MG in China.
- Conditions
- Myasthenia Gravis
- Being tested
- HBM9161 Injection (680mg and 340 mg), Placebos, HBM9161 Injection (340 mg)
- 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 and 340 mg)Drug
HBM9161 Injection (680mg and 340mg)
PlacebosDrug
Placebo, HBM9161 Injection (340mg)
HBM9161 Injection (340 mg)Drug
HBM9161 Injection (340 mg)
| Study group | Role | What they receive |
|---|---|---|
| HBM9161 (680mg and 340 mg) | Experimental | Subcutaneous injection; Blinded: HBM9161 680mg; Open-label: HBM9161 340mg; Receives: Drug: HBM9161 Injection (680mg and 340 mg) |
| HBM9161 (340 mg) | Experimental | Subcutaneous injection; Blinded: HBM9161 340mg; Open-label: HBM9161 340mg; Receives: Drug: HBM9161 Injection (340 mg) |
| Placebo, HBM9161 (340 mg) | Placebo comparator | Subcutaneous injection; Blinded: Placebo; Open-label: HBM9161 340mg; Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline to Day 43
The MG-ADL profile provides an assessment of MG symptom severity and measures 8 items on a 0-3 scale, with 0 being the least severe. The total sum of the 13 items represents the ADL score. The ADL score can range from 0 (least severe) to 24 (most severe)
Measured: 43 days
Secondary outcomes (11)
Change in the Myasthenia Gravis Composite (MGC) score from baseline to Day 43
The total QMG score is obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3). The score ranges from 0 to 39, with lower scores indicating lower disease activity.
Measured: 43 days
Change in the Quantitative Myasthenia Gravis (QMG) score from baseline to Day 43
The QMG test is a standardized quantitative strength scoring system and measures 13 items on a 0-3 scale, with 0 being the least severe. The total sum of the 13 items represents the QMG score. The QMG score can range from 0 (least severe) to 39 (most severe).
Measured: 43 days
Change in the Myasthenia Gravis Quality of Life 15(MG-QoL15r) score from baseline to Day 43
The MG-QoL 15r scale is a patient-reported score that assesses the patient's perception of impairment and disability and the degree to which the patient tolerates disease manifestations. Each question was graded on a 3-point scale from 0=normal to 2=severe with a score of 0 to 30; the higher score indicates worse MG disease activity
Measured: 43 days
Proportion of participants with a decrease on the MG-ADL Score by ≥ 2 points from baseline to Day 43
Measured: 43 days
Proportion of participants with an improvement and worse on the MGFA Post-intervention Status (MGFA-PIS) from baseline to Day 43. o Improvement: MGC Score reduce ≥ 3 points o Aggravation: MGC Score increase ≥ 3 points
Measured: 43 days
Change in the MG-ADL score from baseline to Day 120
Measured: 120 days
Change in the MGC score from baseline to Day 120
Measured: 120 days
Change in the QMG score from baseline to Day 120
Measured: 120 days
Change in the MG-QoL15r score from baseline to Day 120
Measured: 120 days
Proportion of participants with persistent improvement on the MGC score from baseline to Day 120
Improvement (decrease) in the MGC score by ≥ 3 points for 6 weeks
Measured: 120 days
Proportion of participants with persistent improvement on the MG-ADL score from baseline to Day 120
Improvement (decrease) in the MG-ADL Score by ≥ 2 points for 6 weeks
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start23 Jul 2020
- Primary completion24 Aug 2021
- Study completion24 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 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
- NCT04346888
- Sponsor's protocol ID
- 9161.3
- Status last verified
- Mar 2023
- First submitted
- 13 Apr 2020
- Last updated
- 8 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yan C, Duan RS, Yang H, Li HF, Zou Z, Zhang H, Zhou H, Li XL, Zhou H, Jiao L, Chen J, Yin J, Du Q, Lee M, Chen Y, Chen X, Zhao C. Therapeutic Effects of Batoclimab in Chinese Patients with Generalized Myasthenia Gravis: A Double-Blinded, Randomized, Placebo-Controlled Phase II Study. Neurol Ther. 2022 Jun;11(2):815-834. doi: 10.1007/s40120-022-00345-9. Epub 2022 Apr 12.
PubMed 35412216
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 Study to Evaluate the Efficacy, Safety and Pharmacodynamic and Pharmacokinetic of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT04346888
- Acronym / sponsor ID
- 9161.3
- Conditions
- Myasthenia Gravis
- Keywords
- MG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 24 Aug 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 15 Apr 2020 (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 Objectives: To investigate the efficacy of HBM9161 in patients with attack of MG in China
Detailed description
This is a multicenter, randomized, double-blind and placebo-controlled study. The investigational drug is HBM9161 injection, and the indication is MG.
The subjects will be randomized to three dose groups (340mg, 680mg and placebo) for a 6 weeks' double-blind treatment period followed by an open-label extension treatment period. The study will investigate the safety, efficacy and pharmacodynamic and pharmacokinetic of HBM9161 in patients with attack of MG in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HBM9161 (680mg and 340 mg) | Experimental | Drug: HBM9161 Injection (680mg and 340 mg)Subcutaneous injection; Blinded: HBM9161 680mg; Open-label: HBM9161 340mg; |
| HBM9161 (340 mg) | Experimental | Drug: HBM9161 Injection (340 mg)Subcutaneous injection; Blinded: HBM9161 340mg; Open-label: HBM9161 340mg; |
| Placebo, HBM9161 (340 mg) | Placebo comparator | Drug: PlacebosSubcutaneous injection; Blinded: Placebo; Open-label: HBM9161 340mg; |
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 Informed Consent Form.
- Male or female ≥ 18 years of age.
- A female participant is eligible to participate if she is of:
- A male participant must take effective contraception during this clinical trial or their heterosexual partner must take effective contraception.
- 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 (8 listed)
- Use of rituximab, belimumab, eculizumab or any monoclonal antibody/Fc-fusion biologic for immunomodulation within 6 months prior to screening.
- Immunoglobulins given by SC, IV(IVIG), or intramuscular route, or plasmapheresis/plasma exchange (PE) within 4 weeks before screening.
- Thymectomy performed < 12 months prior to screening.
- Total IgG level <6g/L (at screening).
- Participant has any laboratory abnormality (at screening) that, in the opinion of the investigator, is clinically significant, has not resolved at baseline, and could jeopardize or would compromise the participant's ability to participate 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 and 340 mg)HBM9161 Injection (680mg and 340mg) | Drug | HBM9161 (680mg and 340 mg) |
| PlacebosPlacebo, HBM9161 Injection (340mg) | Drug | Placebo, HBM9161 (340 mg) |
| HBM9161 Injection (340 mg)HBM9161 Injection (340 mg) | Drug | HBM9161 (340 mg) |
Primary outcome
Change in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline to Day 43
Time frame: 43 days
The MG-ADL profile provides an assessment of MG symptom severity and measures 8 items on a 0-3 scale, with 0 being the least severe. The total sum of the 13 items represents the ADL score. The ADL score can range from 0 (least severe) to 24 (most severe)
11 secondary outcomes
Change in the Myasthenia Gravis Composite (MGC) score from baseline to Day 43
Time frame: 43 days
Change in the Quantitative Myasthenia Gravis (QMG) score from baseline to Day 43
Time frame: 43 days
Change in the Myasthenia Gravis Quality of Life 15(MG-QoL15r) score from baseline to Day 43
Time frame: 43 days
Proportion of participants with a decrease on the MG-ADL Score by ≥ 2 points from baseline to Day 43
Time frame: 43 days
Proportion of participants with an improvement and worse on the MGFA Post-intervention Status (MGFA-PIS) from baseline to Day 43. o Improvement: MGC Score reduce ≥ 3 points o Aggravation: MGC Score increase ≥ 3 points
Time frame: 43 days
Change in the MG-ADL score from baseline to Day 120
Time frame: 120 days
Change in the MGC score from baseline to Day 120
Time frame: 120 days
Change in the QMG score from baseline to Day 120
Time frame: 120 days
Change in the MG-QoL15r score from baseline to Day 120
Time frame: 120 days
Proportion of participants with persistent improvement on the MGC score from baseline to Day 120
Time frame: 120 days
Proportion of participants with persistent improvement on the MG-ADL score from baseline to Day 120
Time frame: 120 days
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 35412216Yan C, Duan RS, Yang H, Li HF, Zou Z, Zhang H, Zhou H, Li XL, Zhou H, Jiao L, Chen J, Yin J, Du Q, Lee M, Chen Y, Chen X, Zhao C. Therapeutic Effects of Batoclimab in Chinese Patients with Generalized Myasthenia Gravis: A Double-Blinded, Randomized, Placebo-Controlled Phase II Study. Neurol Ther. 2022 Jun;11(2):815-834. doi: 10.1007/s40120-022-00345-9. Epub 2022 Apr 12.
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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 2 study testing HBM9161 Injection (680mg and 340 mg) and HBM9161 Injection (340 mg) 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 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline to Day 43 (time frame: 43 days). 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 NCT04346888, which also lists 1 linked publication.
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.