Overview

A Multicenter, Open-label Extension Study Evaluating the Efficacy and Safety of IBI311 in Subjects With Thyroid Eye Disease

Status:
Recruiting
Trial end date:
2025-07-30
Target enrollment:
0
Participant gender:
All
Summary
A multicenter, open-label extension study evaluating the efficacy and safety of IBI311 in subjects with thyroid eye disease
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Criteria
Inclusion Criteria:

1. Comply with the test procedure and voluntarily sign the informed consent;

2. Male or female subjects aged between 18 and 80 years (inclusive) at the time of FU1
visit;

3. For subjects who completed CIBI311A201 double-blind treatment period, the cohort date
from the end of CIBI311A201 study was no more than 28 days;

4. If the subject is female, it should be postmenopausal or after surgical sterilization
or FU1 visit urine pregnancy test negative and agree to take contraceptive measures
within 120 days from FU1 visit to the last dose Women of childbearing age; Male
subjects should agree to use contraception within 120 days from the FU1 visit to the
last dose.

Exclusion Criteria:

1. Visual dysfunction due to optic neuropathy, defined as a decrease of ≥2 lines of best
corrected vision within the last 180 days, a new visual field defect, or color
difference secondary to optic nerve involvementOften;

2. Patients with corneal ulcers that the investigator determined did not resolve after
treatment;

3. When the FU1 visit predecessor was scheduled to receive orbital radiation therapy or
surgery for TED, including orbital decompression, strabismus correction, and eyelid
correction, or during the study periodEtc.;

4. Poor thyroid function control was defined as free T3 or T4 deviating from the normal
reference range of the local research center laboratory by more than 50% during FU1
visit;

5. The presence of any other prior disease, metabolic disorder, abnormal results of
physical examination or clinical laboratory examination, which may reasonably be
suspected to cause contraindications in the use of the test drug, or shadow Diseases
or conditions that place subjects at high risk for treatment complications, including,
but not limited to, confirmed or clinically suspected inflammatory bowel disease and
coagulation Blood dysfunction, history of acute cardiovascular and cerebrovascular
disease or treatment within 180 days prior to FU1 visit (including but not limited to:
cerebrovascular accident, transient cerebral ischemia, acute myocardial infarction)
Death, unstable angina pectoris, coronary artery bypass grafting, percutaneous
coronary intervention (except diagnostic angiography), severe arrhythmia, etc.),
treatment within the past 5 years or A history of untreated malignancy (squamous cell
carcinoma of the skin, basal cell carcinoma, carcinoma in situ of the cervix, prostate
in situ, or thyroid that has been successfully resected without evidence of
metastasis) Other than papillary carcinoma), serious systemic infection, non-TED
caused eye protrusion, etc.;

6. At the time of FU1 visit, either ear was present: a history of tinnitus or other
hearing impairment; Or abnormal pure tone audiometry (defined as 0.5 1 24 4 kHz mean
bone conduction threshold ≥25 dB or either Bone conduction threshold under frequency
≥40 dB);

7. When FU1 visited, aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
were 3 times higher than ULN;

8. When FU1 was visited, Glomerular Filtration Rate (GFR) was < 30 ml/min/1.73 m2 (MDRD
formula: GFR =186× serum creatinine (mg/dl)).-1.154× (age) -0.203× (0.742 [if
female]), unit conversion of blood creatinine: 1 μmol/L=0.0113 mg/dL);

9. The presence of poorly controlled diabetes at FU1 visit (defined as ≥9.0% HBA1C at FU1
visit or a new diabetes medication within 60 days prior to screening]Dose change of
diabetes drugs currently prescribed > 10%);

10. At FU1 visit, poorly controlled hypertension was present, with systolic blood pressure
≥160 mmHg or diastolic blood pressure ≥100 mmHg; Or FU1 adjusted blood pressure
medication (dose or.) within 30 days prior to visit Type of drug); Renal artery
stenosis; Or evidence of unstable blood pressure (including postural hypotension);

11. A 12-lead ECG showing a heart rate < 50 beats/min or > 100 beats/min at the FU1 visit
indicates active heart disease, or an ECG abnormality at the time of the FU1 visit, as
the investigator believes Interfering with the interpretation of ECG results during
follow-up, especially excluding QTcF > 500 ms;

12. Subjects received systemic or local use of glucocorticoids, immunosuppressants, or
biologics (CD20 antibody, interleukin) from the end of CIBI311A201 study until FU1
visit of this study-6 receptor antibody, tetulizumab, etc.) to treat TED;

13. Subjects treated TED with selenium or biotin (except multivitamins containing selenium
or biotin) from the end of CIBI311A201 study to before FU1 visit of this study;

14. Subjects had participated in other interventionary clinical trials (e.g., for drugs,
during their 5 half-lives, with older participants) from the end of the CIBI311A201
study until the FU1 visit of this study Allowed; Vitamins and minerals), or attempting
to participate in other clinical trials during the study period;

15. Pregnant and lactating female subjects;

16. People who are known to be allergic to the ingredients of the investigational drug, or
have a pre-existing allergy to other monoclonal antibodies;

17. Participants considered unsuitable for this clinical trial due to other reasons.