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

Myasthenia Gravis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05332210
• Other study ID #: 9161.7
• Status: Recruiting
• Phase: Phase 3
• Start date: June 30, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2023
• Source: Harbour BioMed (Guangzhou) Co. Ltd.
• Contact: Chongbo Zhao
• Phone: +86 13701822316
• Email: zhao_chongbo[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: December 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Completed the HBM9161.3 Phase 3 study

2. Signed written informed consent.

3. Suitable for continued treatment with HBM9161 as judged by the investigator.

4. 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.

5. A negative urine pregnancy at baseline must be observed for women of childbearing age.

Exclusion Criteria:

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

2. 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.

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis

Intervention

Drug:
• HBM9161 Injection (680mg)
HBM9161 Injection

Locations

Country	Name	City	State
China	Huashan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Harbour BioMed (Guangzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of AEs during the study	Incidence of AEs	during the study,up to 24 weeks
Secondary	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	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)
Secondary	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
Secondary	Proportion of time remained in Minimal Symptom Expression	from baseline to Week 24, percentage of time MG-ADL score being 0 or 1	during the study,up to 24 weeks
Secondary	Improvement of patients' quality of life	Improvement of patients' quality of life	during the study,up to 24 weeks
Secondary	Incidence and duration of serum anti-HBM9161 antibodies and neutralizing antibodies	Incidence and duration of serum anti-HBM9161 antibodies and neutralizing antibodies	during the study,up to 24 weeks