A Study of IBI311 in Subjects With Steroid-resistant, Thyroid Associated Ophthalmopathy (NCT06269393) | Clinical Trial Compass
CompletedPhase 3
A Study of IBI311 in Subjects With Steroid-resistant, Thyroid Associated Ophthalmopathy
China53 participantsStarted 2024-01-01
Plain-language summary
This is an exploratory study of the efficacy and safety of IBI311, a modified anti-IGF-1R antibody, in patients with steroid-resistant, thyroid associated ophthalmopathy (TAO). This study includes two stages. Stage I is a single-center, single-arm, open-label clinical study designed to evaluate the safety and tolerability of IBI311 in subjects with TAO. Approximately 10 subjects meeting the study eligibility criteria will be enrolled. Stage II is a single-center, randomized, double-masked, placebo-controlled clinical trial designed to evaluate the efficacy and safety of IBI311 in subjects with steroid-resistant TAO. Approximately 54 subjects meeting the study eligibility criteria will be randomly assigned to IBI311 or placebo on day 1 (D1) in a 2:1 ratio stratified by disease activity.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Written informed consent.
✓. Male or female subject between 18 and 80 years (inclusive) at Screening.
✓. Steroid-resistant TAO, defined as poor response to steroid after completing a 3-month steroid pulse therapy (4.5g to 8.0g methylprednisolone) or 3-6 months of oral glucocorticoids treatment (i.e., CAS decreased by \< 2 points, or proptosis decreased by \< 2mm, or no improvement in diplopia), or relapse of TAO after steroid withdrawal (CAS increased by ≥2 points and CAS≥3 points \[7-item scale\] in either eye, or proptosis increased by ≥2 mm, or Gorman diplopia score increased by ≥1 point).
✓. Moderate-to-severe active TAO or chronic TAO at screening:
✓. Infertile female subjects or fertile female subjects with negative blood pregnancy test results during the screening period and agrees to take contraceptive measures from screening to 120 days after the last dose; male subjects should agree to use contraceptive measures from screening to 120 days after the last dose.
Exclusion criteria
✕. Decreased best-corrected visual acuity due to optic neuropathy (defined as a ≥ 2-line decrease in best-corrected visual acuity due to optic neuropathy within the past 180 days), newly emerging visual field defects or color vision impairment secondary to optic nerve damage;
What they're measuring
1
The proptosis responder rate (defined as percentage of subjects with a ≥ 2mm reduction from baseline in proptosis in the study eye, without deterioration [≥ 2 mm increase] of proptosis in the non-study eye) of the study eye.
✕. Immediate orbital radiotherapy or orbital decompression as judged by investigators;
✕. Orbital radiation therapy or surgical treatment for TAO, including orbital decompression, strabismus diorthosis and eyelid diorthosis, at any time before baseline, or planned to have the aforementioned treatments during the study;
✕. Subjects with poorly controlled thyroid function, defined as FT3 or FT4 levels deviating from the normal reference ranges of the local study site laboratories by more than 50% at screening;
✕. Receiving Teprotumumab or IBI311 at any time before baseline;
✕. Receiving anti-CD20 antibody or interleukin-6 receptor antibody treatment within 180 days prior to baseline;
✕. Oral or intravenous administration of any other non-steroid immunosuppressant within 90 days prior to baseline