A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants with Active Thyroid Eye Disease (TED)

Conditions

Thyroid Eye Disease

Brief summary

Proportion of proptosis responders (proptosis responder rate) at Week 24 where proptosis responder is defined as the participant with a ≥ 2 mm reduction in the study eye without deterioration (≥ 2 mm increase) in the fellow eye.

Detailed description

Proportion of participants with proptosis ≥ 2 mm reduction and CAS ≤ 3 at Week 24 from baseline in the study eye., Proportion of participants with CAS of 0 or 1 at Week 24 in the study eye., Mean change from baseline to Week 24 in CAS in the study eye., Proportion of participants with positive binding anti-TSHR Ab at baseline who achieve seroconversion at Week 24., Proportion of participants with decrease of at least 1 grade from baseline in Gorman score for diplopia at Week 24 in participants who have diplopia at baseline., Mean change from baseline to Week 24 in proptosis (mm) in the study eye., Proportion of participants with ≥ 6-point increase from baseline in total GO-QOL score at Week 24 in participants who have the ability to increase by ≥ 6 points from baseline., Proportion of participants with ≥8 degree increase from baseline in motility (in at least 1 of 4 directions) at Week 24 in the study eye in participants who have the ability to increase by ≥ 8 degrees from baseline.

Related papers

No related papers found yet.

Interventions

DRUGPlacebo is identical to IMP but with no active substance.

DRUGBatoclimab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of proptosis responders (proptosis responder rate) at Week 24 where proptosis responder is defined as the participant with a ≥ 2 mm reduction in the study eye without deterioration (≥ 2 mm increase) in the fellow eye.	—

Secondary

Measure	Time frame
Proportion of participants with proptosis ≥ 2 mm reduction and CAS ≤ 3 at Week 24 from baseline in the study eye., Proportion of participants with CAS of 0 or 1 at Week 24 in the study eye., Mean change from baseline to Week 24 in CAS in the study eye., Proportion of participants with positive binding anti-TSHR Ab at baseline who achieve seroconversion at Week 24., Proportion of participants with decrease of at least 1 grade from baseline in Gorman score for diplopia at Week 24 in participants who have diplopia at baseline., Mean change from baseline to Week 24 in proptosis (mm) in the study eye., Proportion of participants with ≥ 6-point increase from baseline in total GO-QOL score at Week 24 in participants who have the ability to increase by ≥ 6 points from baseline., Proportion of participants with ≥8 degree increase from baseline in motility (in at least 1 of 4 directions) at Week 24 in the study eye in participants who have the ability to increase by ≥ 8 degrees from baseline.	—

Measure

Time frame

Proportion of participants with proptosis ≥ 2 mm reduction and CAS ≤ 3 at Week 24 from baseline in the study eye., Proportion of participants with CAS of 0 or 1 at Week 24 in the study eye., Mean change from baseline to Week 24 in CAS in the study eye., Proportion of participants with positive binding anti-TSHR Ab at baseline who achieve seroconversion at Week 24., Proportion of participants with decrease of at least 1 grade from baseline in Gorman score for diplopia at Week 24 in participants who have diplopia at baseline., Mean change from baseline to Week 24 in proptosis (mm) in the study eye., Proportion of participants with ≥ 6-point increase from baseline in total GO-QOL score at Week 24 in participants who have the ability to increase by ≥ 6 points from baseline., Proportion of participants with ≥8 degree increase from baseline in motility (in at least 1 of 4 directions) at Week 24 in the study eye in participants who have the ability to increase by ≥ 8 degrees from baseline.

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Countries

Belgium, Germany, Hungary, Latvia, Slovakia, Spain

Outcome results

None listed