MedTrace Logo

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

NCT05015127 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-02-23

No results posted yet for this study

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.

Conditions

  • Thyroid Ophthalmopathy

Interventions

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

Sponsors & Collaborators

  • Harbour BioMed (Guangzhou) Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Huifang Zhou · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-22
Primary Completion
2022-10-31
Completion
2022-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05015127 on ClinicalTrials.gov