NCT05015127

A Study to Evaluate the Efficacy and Safety of HBM9161 on Moderate to Severe Thyroid Eye Disease

A Randomized, Double-blind, Placebo-controlled, Phase 2/3 Operational Seamless Design Clinical Study to Evaluate the Efficacy and Safety of HBM9161 Subcutaneous Injection in Chinese Patients With Active, Moderate to Severe Thyroid Eye Disease (TED)

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Harbour BioMed (Guangzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To preliminarily evaluate the efficacy of the treatment regimen of HBM9161 680 mg administered subcutaneously weekly and sequentially every other week for 12 weeks in Chinese patients with active moderate to severe TED.

Detailed description

This is a multicenter, randomized, double-blind and placebo-controlled study. The investigational drug is HBM9161 injection, with the indication of TED. Subjects will be randomized to treatment group I, treatment group II, or placebo group. Subjects in treatment group 1 will receive HBM9161 680 mg subcutaneously once weekly (qw) for 12 doses; Subjects in treatment group 2 will receive HBM9161 680 mg subcutaneously once weekly (qw) for 6 doses, followed by HBM9161 680 mg subcutaneously once every two weeks (q2w) for 3 doses; Subjects in placebo group will receive placebo subcutaneously once weekly (qw) for 12 doses. After the 12-week dosing period, there will be a 5-week follow-up period.

Conditions

• Thyroid Ophthalmopathy

Interventions

Type	Name	Description
DRUG	HBM9161 680 mg qw by q2w from week 13	HBM9161 680 mg qw by q2w from week 13
DRUG	Placebo	Placebo
DRUG	HBM9161 680 mg qw by q2w from week 7	HBM9161 680 mg qw by q2w from week 7
DRUG	Placebo	Placebo qw by HBM9161 680mg qw from week 12

Timeline

• Start date: 2021-09-22
• Primary completion: 2022-10-01
• Completion: 2022-12-01
• First posted: 2021-08-20
• Last updated: 2022-02-23

Locations

1 site across 1 country: China