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
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
III
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Keywords
Contact Us
Research_Recruitment@jh.eduBrief Summary
The purpose of this study is to determine the safety and efficacy of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).
Eligibility
Inclusion Criteria:
- Adult subjects (18-75 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:
- Lymphoproliferative disorder
- active malignancy
- 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.)
- thrombosis orand cerebrovascularardiovascular ischemic event disease within the last 12 months
- a high risk for herpes zoster reactivation
- active or recent infections