Thyroid eye disease
Conditions
Brief summary
Overall Responder Rate comprised of Proptosis Responder Rate in the most proptotic eye (i.e., reduction of proptosis of ≥ 2 mm from baseline [without a corresponding increase of ≥ 2 mm in the other eye]) at 3 weeks post the fifth IV infusion (i.e., Week 15) and Clinical Activity Responder Rate in the most proptotic eye (i.e., no worsening in CAS from baseline [without a corresponding increase of ≥2 points in the other eye]) at 3 weeks post the fifth IV infusion (i.e., Week 15), Safety Endpoints: Adverse Events (AEs) and Serious Adverse Events (SAEs) will be monitored and recorded throughout the duration of the study. All clinically significant changes in other safety assessments will be recorded as AEs.
Detailed description
Change from baseline in proptosis in the most proptotic eye at Week 15, Proptosis Responder Rate in the most proptotic eye as measured by exophthalmometer at Week 15., Change from baseline in proptosis in the most proptotic eye as measured by exophthalmometer at Week 15.
Interventions
Sponsors
Viridian Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Responder Rate comprised of Proptosis Responder Rate in the most proptotic eye (i.e., reduction of proptosis of ≥ 2 mm from baseline [without a corresponding increase of ≥ 2 mm in the other eye]) at 3 weeks post the fifth IV infusion (i.e., Week 15) and Clinical Activity Responder Rate in the most proptotic eye (i.e., no worsening in CAS from baseline [without a corresponding increase of ≥2 points in the other eye]) at 3 weeks post the fifth IV infusion (i.e., Week 15), Safety Endpoints: Adverse Events (AEs) and Serious Adverse Events (SAEs) will be monitored and recorded throughout the duration of the study. All clinically significant changes in other safety assessments will be recorded as AEs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in proptosis in the most proptotic eye at Week 15, Proptosis Responder Rate in the most proptotic eye as measured by exophthalmometer at Week 15., Change from baseline in proptosis in the most proptotic eye as measured by exophthalmometer at Week 15. | — |
Countries
Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Spain
Outcome results
None listed