Thyroid Eye Disease (TED)
Conditions
Interventions
Treatment Group 1:HBM9161 Once a week
Treatment Group 2:HBM9161 1 time / week + 2 times / week
Placebo Group:Placebo
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Sign the written informed consent; 2. No gender limit, aged >=18 years; 3. Active TED associated with a clinical diagnosis of Graves' disease or Hashimoto's thyroiditis, and the eye with the most severe proptosis had a CAS >= 3 at the screening visit and at baseline (both using a 7-item scale); 4. The TED event period begins within 9 months prior to the screening visit; 5. Anti-TSHR antibody positive at the screening visit; 6. Subjects are willing and able to receive treatment and complete appropriate assessments as required by the protocol.
Exclusion criteria
Exclusion criteria: 1. Other uncontrolled concomitant diseases; 2. Pregnancy; 3. Severe TED requires surgery or radiation therapy; 4. Suffering from autoimmune diseases or ophthalmic diseases other than TED, which the investigator believes will affect the evaluation of the study drug in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exophthalmos response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of subjects with a CAS value of 0 or 1 in the study eye;The change from baseline in proptosis measurement in the study eye;The change from baseline in CAS score in study eye;Composite responder rate;The change from baseline in GO quality of life scale (GO-QoL);Diplopia response rate;The changes in proptosis responder rate over time; | — |
Countries
China
Contacts
Public ContactZhou Huifang
Outcome results
None listed