A Multicenter, Open-label Extension Study Evaluating the Efficacy and Safety of IBI311 in Subject… (NCT06126783) | Clinical Trial Compass
CompletedPhase 3
A Multicenter, Open-label Extension Study Evaluating the Efficacy and Safety of IBI311 in Subjects With Thyroid Eye Disease
China91 participantsStarted 2023-10-20
Plain-language summary
A multicenter, open-label extension study evaluating the efficacy and safety of IBI311 in subjects with thyroid eye disease
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Comply with the test procedure and voluntarily sign the informed consent;
✓. Male or female subjects aged between 18 and 80 years (inclusive) at the time of FU1 visit;
✓. For subjects who completed CIBI311A201 double-blind treatment period, the cohort date from the end of CIBI311A201 study was no more than 28 days;
✓. 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
✕. 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;
✕. Patients with corneal ulcers that the investigator determined did not resolve after treatment;
✕. 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.;
✕. 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;
✕. 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.;
✕. 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);
What they're measuring
1
The response rate of exophthalmos was studied.
Timeframe: After receiving IBI311 treatment for 24 weeks