A 48 Week Phase II, Randomized, Open-Label, Multicenter, Study to Evaluate the Efficacy and Safety of Two (2) EYS606 Treatment Regimens in Subjects With Active Chronic Non-infectious Uveitis (CNIU)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Non-infectious Uveitis
- Sponsor
- Eyevensys
- Enrollment
- 3
- Locations
- 3
- Primary Endpoint
- Time to rescue therapy between the two EYS606 treatment regimens
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The objective of the study is to evaluate the efficacy and safety of two different treatment regimens of EYS606.
Detailed Description
This is a Phase 2, multi-center, randomized open-label interventional study of EYS606 in subjects with active chronic non-infectious uveitis. The maximum study duration per patient is 51 Weeks (including an up to 3 week screening period + 48 weeks follow-up after treatment). The study will be conducted in 2 parts. Part I is a safety cohort phase that will enroll up to 6 subjects, Part II is the randomized comparison phase that will enroll up to an additional 50 subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Time to rescue therapy between the two EYS606 treatment regimens
Time Frame: Week 24
Assessment of efficacy measured as time to rescue therapy required after treatment with EYS606
Secondary Outcomes
- Median time to control of active CNIU(Each Visit up to Week 48)
- Median time to loss of treatment effect(Each Visit up to Week 48)
- Proportion (%) of subjects responded to the treatment(Week 8 and 24)
- Median change in visual acuity(Each Visit up to Week 48)
- Proportion (%) of subjects achieving and maintaining active chronic noninfectious posterior uveitis (CNIU)(Week 24)