Uveitis Clinical Trial
— CLARITYOfficial title:
A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Active, Non-Infectious Intermediate-, Posterior-, and Panuveitis
Verified date | May 2024 |
Source | Priovant Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the safety and efficacy (including corticosteroid-sparing effect) of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).
Status | Not yet recruiting |
Enrollment | 220 |
Est. completion date | August 23, 2027 |
Est. primary completion date | August 23, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 74 Years |
Eligibility | Inclusion Criteria: - Adult subjects (18-74 years old) - Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis). - Active uveitic disease in at least 1 eye. - Weight > 40 kg with a body mass index < 40 kg/m2. Exclusion Criteria: - Has confirmed or suspected current diagnosis of infectious uveitis - History of or have: 1. Lymphoproliferative disorder 2. active malignancy; 3. cancer within 5 years prior to screening (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.) 4. thrombosis and cardiovascular disease within the last 12 months 5. a high risk for herpes zoster reactivation 6. active or recent infections |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Priovant Therapeutics, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of participants meeting treatment failure criteria on or after Week 6 up to Week 24 | 24 weeks | ||
Secondary | Time to treatment failure on or after Week 6 up to Week 24 | 24 weeks | ||
Secondary | Change in logarithm of the minimum angle of resolution (logMAR) best corrected visual acuity (BCVA) in each eye from best state achieved at Week 6 up to Week 24 | 24 weeks | ||
Secondary | Change in central subfield thickness from best state achieved in each eye at or prior to Week 6 up to Week 24 | 24 weeks |
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