Thyroid Ophthalmopathy
Conditions
Keywords
TED
Brief 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.
Interventions
DRUGHBM9161 680 mg qw by q2w from week 13
HBM9161 680 mg qw by q2w from week 13
DRUGPlacebo
Placebo
DRUGHBM9161 680 mg qw by q2w from week 7
HBM9161 680 mg qw by q2w from week 7
Sponsors
Harbour BioMed (Guangzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Signed written informed consent form. 2. Male or female between the ages of 18 and 70 (including boundary values). 3. Active TED associated with a clinical diagnosis of Graves' disease or Hashimoto's thyroiditis with CAS ≥ 3 at the screening visit and baseline (both on a 7-item scale) in the eye with the most severe proptosis. 4. The active period of TED starts within 9 months prior to screening visit 5. Positive anti-TSHR antibody at screening visit. 6. Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol.
Exclusion criteria
1. Other uncontrolled concurrent diseases 2. Serious TED requiring surgery or radiotherapy 3. Suffer from autoimmune diseases or ophthalmic conditions other than TED that, in the opinion of the investigator, would impact the assessment of the study drug 4. No significant laboratory abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change from Baseline in proptosis measurement in the study eye | At week 6, week 12, week 18 and week 24 | The change from Baseline in proptosis measurement in the study eye |
| Composite responder rate | At week 6, week 12, week 18 and week 24 | Composite responder rate |
| Diplopia response rate | At week 6, week 12, week 18 and week 24 | Diplopia response rate |
| The percentage of subjects with a CAS value of 0 or 1 in the study eye | At week 6, week 12, week 18 and week 24 | The percentage of subjects with a CAS value of 0 or 1 in the study eye |
| The changes in proptosis responder rate over time | From week 1 to week 24 | The changes in proptosis responder rate over time |
| The change from baseline in quantitative measurement of orbital structures by MRI, including exophthalmos values, fatty tissue thickness of inner side in eye balls, thickness of extraocular muscles. All the above parameters will be measured in millimeter | At week 12, week 24 | The change from baseline in quantitative measurement of orbital structures by MRI, including exophthalmos values, fatty tissue thickness of inner side in eye balls, thickness of extraocular muscles. All the above parameters will be measured in millimeter |
| The change from baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire visual function score and psychosocial function score | At week 6, week 12, week 18 and week 24 | The change from baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire visual function score and psychosocial function score |
Countries
China
Contacts
Primary ContactHuifang Zhou
Backup ContactJing Sun
Outcome results
None listed