Thyroid eye disease
Conditions
Brief summary
The primary study endpoint will assess the percentage of participants who have a response called Overall Responder Rate at Week 24. An Overall Responder is a participant who achieves a ≥ 2 mm reduction in eye bulging AND shows no worsening in Clinical Activity Score or CAS (that is an estimate of disease severity/symptoms) at Week 24 versus measurements before the first dose.
Detailed description
The secondary endpoints will assess changes in eye bulging versus measurements before the first dose, and percent of participants who achieve the required reduction in eye bulging, disease severity and symptoms, and reduction and resolution of double vision at Week 24., Safety Endpoint: the study will also evaluate safety events (side effects), the effects of VRDN-003 on the body and vice-versa throughout the study.
Interventions
Sponsors
Viridian Therapeutics S.à.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint will assess the percentage of participants who have a response called Overall Responder Rate at Week 24. An Overall Responder is a participant who achieves a ≥ 2 mm reduction in eye bulging AND shows no worsening in Clinical Activity Score or CAS (that is an estimate of disease severity/symptoms) at Week 24 versus measurements before the first dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints will assess changes in eye bulging versus measurements before the first dose, and percent of participants who achieve the required reduction in eye bulging, disease severity and symptoms, and reduction and resolution of double vision at Week 24., Safety Endpoint: the study will also evaluate safety events (side effects), the effects of VRDN-003 on the body and vice-versa throughout the study. | — |
Countries
Germany, Hungary, Netherlands, Poland, Spain
Outcome results
None listed