Status:
COMPLETED
A Study of IBI311 in Subjects With Inactive or Active Thyroid Eye Disease
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Thyroid Eye Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is a multicenter, randomized, double-masked phase II study evaluating the efficacy and safety of IBI311 in subjects with inactive or active thyroid eye disease. Approximately 36 subjects meeting ...
Eligibility Criteria
Inclusion
- Key
- Written informed consent.
- Male or female subject between the ages of 18 and 80 years at screening.
- Weight between 50 kg and 100 kg.
- Moderate-to-severe active TED:
- CAS ≥ 3 in the study eye at screening and baseline;
- Usually associated with at least two of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal, and/or inconstant or constant diplopia;
- ≤ 12 months since the onset of active TED symptoms according to subjects' chief complaint or medical record at screening;
- Inactive TED:
- According to subjects' chief complaint or medical record at screening, initial diagnosis of TED \> 12 months but \< 10 years prior to screening.
- CAS ≤ 2 in both eyes at screening and baseline and CAS ≤ 2 in both eyes for at least 6 months prior to screening or all of the following at least 6 months prior to screening: a. no progression in proptosis; b. no progression in diplopia; c. no new inflammatory TED symptoms.
- Exophthalmos ≥ 3 mm above normal.
- Exophthalmos ≥ 20 mm in the study eye at baseline.
- Female subjects should be fertile women who are sterile or have a negative blood pregnancy test during the screening period and who agree to take contraceptive measures within 120 days from the screening period to the last medication; Male subjects should agree to use contraception from the screening period to 120 days after the last dose.
- Key
Exclusion
- Subjects will be ineligible for study participation if they meet any of the following criteria:
- Baseline CAS decreased by ≥ 2 points, or baseline proptosis decreased by ≥ 2 mm as compared with screening.
- Visual function impairment due to optic neuropathy, defined as ≥ 2 lines of vision loss, new visual field defect, or color vision impairment secondary to optic nerve involvement within the past 180 days;
- Corneal ulcers with no relief after treatment as determined by the investigator;
- TED patients who need immediate corticosteroid therapy, orbital radiotherapy, or orbital decompression;
- At any time prior to baseline or during the study period planned to receive orbital radiation therapy or TED surgery, including orbital decompression, strabismus surgery, and eyelid retraction correction;
- Poorly controlled thyroid function, which was defined as free triiodothyronine (FT3) or free tetraiodothyronine (FT4) deviated more than 50% from the normal reference range of the local research center laboratory at screening.
- Either ear had a history of tinnitus or other hearing impairment; or abnormal pure tone audiometry (defined as mean bone conduction threshold \[0.5, 1, 2, 4 kHz\] ≥25 dB or any bone conduction threshold ≥ 40 dB);
- Poorly controlled diabetes at screening, defined as HbA1C ≥ 9.0% at screening, or any new medication for diabetes within 60 days prior to screening, or any dose adjustment for diabetes drugs \> 10%);
- Systemic use of glucocorticoids ≤ 30 days prior to screening;
- Periorbital use of glucocorticoids ≤ 90 days prior to screening;
- Systemic use of immunosuppressants ≤ 90 days prior to screening;
- Use glucocorticoid eye drops or immunosuppressive eye drops ≤ 30 days prior to screening
- 12\. Use IBI311 or TEPEZZA at any time prior to screening; 13 Use CD20 antibody ≤ 1 year prior to screening, or IL-6R antibody ≤ 180 days prior to screening; 14. Subjects had participated in other interventional clinical trials ≤ 90 days prior to screening, or attempting to participate in other clinical trials during the study period.
Key Trial Info
Start Date :
September 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2025
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06525506
Start Date
September 4 2024
End Date
September 22 2025
Last Update
October 3 2025
Active Locations (1)
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1
Innovent Biologics (Suzhou) Co. Ltd
Suzhou, Suzhou, China, 215123