A Phase 3, Randomized, Double-masked, Placebo-controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Teprotumumab in Participants with Moderate-to-Severe Active Thyroid Eye Disease

Conditions

Moderate-to-Severe Active Thyroid Eye Disease

Brief summary

Proptosis responder rate (percentage of participants with a ≥ 2-mm reduction from Baseline in proptosis in the study eye without deterioration [≥ 2-mm increase] of proptosis in the fellow eye) at XX Week

Detailed description

Mean change from Baseline at Week XX in proptosis measurement in the study eye., Overall responder rate (percentage of participants with ≥ 2-point reduction in Clinical Activity Score [CAS] AND ≥ 2-mm reduction in proptosis from Baseline, provided there is no corresponding deterioration [≥ 2-point/mm increase] in CAS or proptosis in the fellow eye) at Week XX., Percentage of participants with a CAS value of 0 or 1 at Week XX in the study eye., Change from Baseline at Week XX in diplopia as ordinal response categories., Diplopia responder rate, defined as the percentage of participants with Baseline binocular diplopia > 0 who have a reduction of ≥ 1 grade at Week XX, Complete diplopia responder rate, defined as the percentage of participants with a Baseline binocular diplopia score > 0 and a score of 0 at Week XX, Mean change from Baseline at Week XX in the Graves’ Ophthalmopathy Quality of Life (GO-QoL) questionnaire overall score

Related papers

No related papers found yet.

Interventions

DRUGplacebo for teprotumumab administered SC

DRUGTeprotumumab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proptosis responder rate (percentage of participants with a ≥ 2-mm reduction from Baseline in proptosis in the study eye without deterioration [≥ 2-mm increase] of proptosis in the fellow eye) at XX Week	—

Secondary

Measure	Time frame
Mean change from Baseline at Week XX in proptosis measurement in the study eye., Overall responder rate (percentage of participants with ≥ 2-point reduction in Clinical Activity Score [CAS] AND ≥ 2-mm reduction in proptosis from Baseline, provided there is no corresponding deterioration [≥ 2-point/mm increase] in CAS or proptosis in the fellow eye) at Week XX., Percentage of participants with a CAS value of 0 or 1 at Week XX in the study eye., Change from Baseline at Week XX in diplopia as ordinal response categories., Diplopia responder rate, defined as the percentage of participants with Baseline binocular diplopia > 0 who have a reduction of ≥ 1 grade at Week XX, Complete diplopia responder rate, defined as the percentage of participants with a Baseline binocular diplopia score > 0 and a score of 0 at Week XX, Mean change from Baseline at Week XX in the Graves’ Ophthalmopathy Quality of Life (GO-QoL) questionnaire overall score	—

Measure

Time frame

Mean change from Baseline at Week XX in proptosis measurement in the study eye., Overall responder rate (percentage of participants with ≥ 2-point reduction in Clinical Activity Score [CAS] AND ≥ 2-mm reduction in proptosis from Baseline, provided there is no corresponding deterioration [≥ 2-point/mm increase] in CAS or proptosis in the fellow eye) at Week XX., Percentage of participants with a CAS value of 0 or 1 at Week XX in the study eye., Change from Baseline at Week XX in diplopia as ordinal response categories., Diplopia responder rate, defined as the percentage of participants with Baseline binocular diplopia > 0 who have a reduction of ≥ 1 grade at Week XX, Complete diplopia responder rate, defined as the percentage of participants with a Baseline binocular diplopia score > 0 and a score of 0 at Week XX, Mean change from Baseline at Week XX in the Graves’ Ophthalmopathy Quality of Life (GO-QoL) questionnaire overall score

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Countries

France, Germany, Italy, Poland, Spain

Outcome results

None listed