Status:
COMPLETED
A Study to Evaluate the Efficacy, Safety and PD and PK of HBM9161 in MG Patients
Lead Sponsor:
Harbour BioMed (Guangzhou) Co. Ltd.
Conditions:
Myasthenia Gravis
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
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 gr...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04346888
Start Date
July 23 2020
End Date
August 24 2021
Last Update
March 8 2023
Active Locations (1)
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1
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China