A Study to Evaluate the Efficacy, Safety and PD and PK of HBM9161 in MG Patients

NCT ID: NCT04346888

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-23
• Study Completion Date: 2021-08-24

Brief Summary

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.

Conditions

Myasthenia Gravis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HBM9161 (680mg and 340 mg)

Subcutaneous injection; Blinded: HBM9161 680mg; Open-label: HBM9161 340mg;

Group Type: EXPERIMENTAL

HBM9161 Injection (680mg and 340 mg)

Intervention Type: DRUG

HBM9161 Injection (680mg and 340mg)

HBM9161 (340 mg)

Subcutaneous injection; Blinded: HBM9161 340mg; Open-label: HBM9161 340mg;

Group Type: EXPERIMENTAL

HBM9161 Injection (340 mg)

Intervention Type: DRUG

HBM9161 Injection (340 mg)

Placebo, HBM9161 (340 mg)

Subcutaneous injection; Blinded: Placebo; Open-label: HBM9161 340mg;

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Placebo, HBM9161 Injection (340mg)

Interventions

HBM9161 Injection (680mg and 340 mg)

HBM9161 Injection (680mg and 340mg)

Intervention Type: DRUG

Placebos

Placebo, HBM9161 Injection (340mg)

Intervention Type: DRUG

HBM9161 Injection (340 mg)

HBM9161 Injection (340 mg)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Signed Informed Consent Form.

2. Male or female ≥ 18 years of age.

3. A female participant is eligible to participate if she is of:

1. Non-childbearing potential (physically infertile, including women who have been menopausal for 2 years or more);

2. 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.

4. A male participant must take effective contraception during this clinical trial or their heterosexual partner must take effective contraception.

5. 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.

6. Screening and baseline MG-ADL score ≥ 6, and < 50% of them is from ocular muscle.

7. Stable background MG treatments at randomization.

8. Positive serologic test for AChR-Ab or MUSK-Ab at the screening visit and at least 1 of the following:

1. History of abnormal neuromuscular transmission test demonstrated by sign-fiber-electromyography or repetitive nerve stimulation OR

2. History of positive edrophonium chloride test OR

3. Participant has demonstrated improvement in MG signs on oral cholinesterase inhibitors as assessed by the treating physician.

Exclusion Criteria

1. Use of rituximab, belimumab, eculizumab or any monoclonal antibody/Fc-fusion biologic for immunomodulation within 6 months prior to screening.

2. Immunoglobulins given by SC, IV(IVIG), or intramuscular route, or plasmapheresis/plasma exchange (PE) within 4 weeks before screening.

3. Thymectomy performed < 12 months prior to screening.

4. Total IgG level <6g/L (at screening).

5. 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.

6. Have known autoimmune disease other than MG that would interfere with the course and conduct of the study (such as uncontrolled thyroid disease).

7. Have an active infection, a recent serious infection (i.e., requiring injectable antimicrobial therapy or hospitalization) within the 8 weeks prior to screening.

8. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harbour BioMed (Guangzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chongbo Zhao

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 35412216 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

9161.3

Identifier Type: -

Identifier Source: org_study_id