A Phase 3b/4, Double-masked, Randomized, International, Parallel-assignment, Multicenter Trial in Patients with Thyroid Eye Disease to Evaluate the Safety and Tolerability of Different Dosing Durations of Teprotumumab

Thyroid Eye Disease

The percentage of patients who experience at least 1 TEAE and the percentage of patients who experience at least 1 treatment-emergent AESI during treatment with teprotumumab. . The percentage of patients who receive re-treatment

Mean change from Baseline in proptosis measurement in the study eye., Proptosis responder rate (percentage of patients with a ≥2-mm reduction from Baseline in proptosis in the study eye, without deterioration [≥2-mm increase] of proptosis in the fellow eye)., The overall responder rate (percentage of patients with ≥2-point reduction in CAS AND ≥2-mm reduction in proptosis from Baseline in the study eye, provided there is no corresponding deterioration [≥2 point/mm increase] in CAS or proptosis in the fellow eye)., The binocular diplopia responder rate (percentage of patients with baseline binocular diplopia >0 who have a reduction of ≥1 grade)., The binocular diplopia resolution rate (percentage of patients with baseline binocular diplopia >0 who have no binocular diplopia)., Mean change from Baseline in the GO-QoL questionnaire appearance and visual functioning sub-scales., Rate of flares at the end of the Initial Follow-up Period., Time to proptosis response from the first infusion until the end of the Initial Treatment Period., CAS: - Proportion of patients with a CAS ≥3 at Baseline who have a CAS of 0 or 1 at the end of the Initial Treatment Period - Proportion of patients who improve on individual questions on the CAS for - spontaneous orbital pain - gaze-evoked orbital pain., Proportion of patients with complete response at the end of the Initial Follow-up Period, as defined by durability of complete response, Proportion of patients with response at the last assessment in the Initial Follow-up Period, as defined by durability of response at the last assessment in the Initial Follow-up Period., Mean change from Baseline over time in disease biomarkers for patients with a Baseline CAS ≥3., "All other endpoints, except the time to proptosis response, rate of flares at the end of the Initial Follow-up Period, durability of complete response and durability of response at the last assessment in the Initial Follow-up Period, will be assessed by randomized cohort at the end of the Initial Treatment Period, at the end of the Initial Follow-up Period., For patients who require re-treatment, the same endpoints will be estimated at the end of the 24-week Re-treatment Period., Safety and Tolerability Endpoints 1. Incidence of TEAEs, SAEs, TEAEs resulting in premature discontinuation of treatment and treatment-emergent AESIs (infusion reactions, hyperglycemia, hearing impairment, new onset IBD and exacerbation of IBD). ", 2. Incidence of ≥Grade 3 TEAEs. 3. Incidence of ≥Grade 3 laboratory evaluations, in which CTCAE grading is available. 4. The results of best-corrected visual acuity. PK and ADA Endpoints 1. Peak and trough concentrations of teprotumumab. 2. ADA incidence and titers."

No related papers found yet.

France, Germany, Italy, Spain