A Study of IBI311 in Subjects With Inactive or Active Thyroid Eye Disease
NCT Number: NCT06525506
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Thyroid Eye Disease
Interventions: BIOLOGICAL: IBI311 (20 mg)|BIOLOGICAL: IBI311 (3-20 mg)|BIOLOGICAL: IBI311 (10 mg)|BIOLOGICAL: IBI311 (3-10mg/kg)
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-02
Completion Date: 2025-12-31
Locations: Innovent Biologics (Suzhou) Co. Ltd, Suzhou, Suzhou, 215123, China

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 the study eligibility criteria will be randomly assigned to the 3-10 mg group, 3-20 mg group, 10 mg group, or 20 mg group on day 1 in a 1:1:2:2 ratio. Dose conversion of the 3-10 mg or 3-20 mg group was performed at week 12. Active and inactive TED was a stratification factor in this study. Active and inactive TED subjects were enrolled in a 1:1 ratio.

Primary Outcome Measures: Mean change from Baseline in proptosis in the study eye., Proptosis assessment: protrusion of the eye from the orbital rim as measured by Hertel exophthalmometer., Week 12|Safety and Tolerability, Incidence, severity, and association with the study drug of ocular and systemic adverse events (AE), treatment-emergent adverse events (TEAE), and serious adverse events (SAE)., After receiving IBI311 treatment for 48 weeks
Secondary Outcome Measures: The proptosis responder rate in the study eye, Defined as percentage of subjects with a ≥ 2 mm reduction from baseline in proptosis in the study eye, without deterioration \[≥ 2 mm increase\] of proptosis in the non-study eye., Week 12, 24 and 48|Mean change from Baseline in proptosis in the study eye., Proptosis assessment: protrusion of the eye from the orbital rim as measured by Hertel exophthalmometer., Week 24 and 48|The overall responder rate in the study eye., Defined as participants with a reduction in clinical activity score (CAS) of ≥ 2 points, and a reduction in proptosis of ≥ 2 mm in the study eye, and no deterioration (increase in CAS of ≥ 2 points or increase in proptosis of ≥ 2 mm) in the non-study eye., Week 12, 24 and 48|Percentage of subjects with a CAS of 0 or 1 in the study eye., According to the 7-item European Group on Graves' Ophthalmopathy (EUGOGO) amendment, CAS was used to evaluate clinical activity. For each of the following items, one point is given: spontaneous orbital pain, gaze evoked orbital pain, eyelid swelling that is considered to be due to active (inflammatory phase) Graves' ophthalmopathy (GO), eyelid erythema, conjunctival redness that is considered to be due to active (inflammatory phase) GO, chemosis, and inflammation of caruncle or plica. The sum of these points is the total score, with 0 indicating no clinical activity and 7 indicating the most severe clinical activity., Week 12, 24 and 48|Mean change from Baseline in CAS in the study eye., Week 12, 24 and 48|Positive responder rate to IBI311 treatment in the study eye., Defined as:

1. ≥2 mm reduction of lid aperture;
2. ≥1 point reduction in five-item CAS (excluding subjective, patient-reported spontaneous or gaze-evoked pain),
3. ≥2 mm reduction in exophthalmos,
4. ≥8° increase of eye muscle duction; Improvement in ≥2 features in the study eye without deterioration in the non-study eye, Week 12, 24 and 48|The impact of IBI311 on the quality of life., Changes in Graves' Ophthalmopathy Quality of Life (GO-QoL) questionnaire score, Week 12, 24 and 48|The diplopia responder rate, Defined as subjects with a ≥ 1-point improvement in Gorman diplopia score., Week 12, 24 and 48|The relapse rate after IBI311 treatment, Defined as proptosis increased by ≥2 mm from baseline and/or CAS increased by ≥2 points from baseline with total CAS score ≥3 in either eye., Week 28, 36 and 48|Systemic Pharmacokinetics profile of IBI311, Descriptive statistics will be performed for concentration data, and the corresponding Pharmacokinetics parameters will be estimated if sufficient data are available., From Day 1 to week 24|Change from Baseline in MRI in the study eye., Changes in exophthalmia from baseline on MRI at week 12, 24, and 48; Changes in the volume and maximum thickness of extraocular muscle, orbital fat and lacrimal gland on MRI from baseline at week 12, 24 and 48; Changes in MRI signal of intraorbital tissue from baseline at week 12, 24 and 48., Week 12, 24 and 48