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Clinical Trial Summary

Primary study objective: To verify the efficacy of HBM9161 subcutaneous injection in Chinese patients with gMG

Clinical Trial Description

This is 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 Phase 3 study design: A total of 120 subjects with positive AChR-Ab or MuSK-Ab and up to 24 subjects with negative AChR-Ab and MuSK-Ab are planned for this phase (The randomization will end after approximately 120 subjects with positive serum AchR-Ab or MUSK-Ab are enrolled) and randomized into 2 treatment regimens in a 1:1 ratio. Arm 1 will receive HBM9161 680 mg; Arm 2 will receive placebo. Whether or not AChR-Ab or MuSK-Ab is positive, and whether or not concomitant steroids are used will be randomization stratification factors. First, eligible subjects will be screened into the double-blind treatment phase and blindly assigned to receive either HBM9161 680 mg or placebo for the first treatment period, administered once weekly (QW) for 6 doses. Subjects who complete the first treatment period will start the administration of the second treatment period if they meet the dosing criteria for the second treatment period at Week 9. The second treatment period will be administered once weekly (QW) for a total of 6 doses in the first treatment period, followed by an observation period (4 weeks) and a follow-up period. Subjects will be dosed for up to two treatment cycles during the study. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05039190
Study type Interventional
Source Harbour BioMed (Guangzhou) Co. Ltd.
Contact Chongbo Zhao
Phone +86 13701822316
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date September 10, 2021
Completion date October 30, 2023

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