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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)
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.
Details
| Lead sponsor | Harbour BioMed (Guangzhou) Co. Ltd. |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | UNKNOWN |
| Enrolment | 36 |
| Start date | 2021-09-22 |
| Completion | 2022-12 |
Conditions
- Thyroid Ophthalmopathy
Interventions
- HBM9161 680 mg qw by q2w from week 13
- Placebo
- HBM9161 680 mg qw by q2w from week 7
- Placebo
Primary outcomes
- Proptosis responder rates of the treatment groups and placebo group at Week 12 — At week 12
Proptosis responder rates of the treatment groups and placebo group at Week 12
Countries
China