Evaluating brepocitinib for adults with active non-infectious uveitis
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
This study is testing if a new medication called brepocitinib can help adults with active non-infectious uveitis feel better and improve their eye health.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Priovant Therapeutics, Inc. Industry-sponsored |
| Drugs / interventions | brepocitinib |
| Locations | 40 sites (Phoenix, Arizona and 39 other locations) |
| Trial ID | NCT06431373 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and effectiveness of brepocitinib in adults suffering from active, non-infectious uveitis, specifically targeting intermediate, posterior, or pan uveitis. Participants will be randomly assigned to receive either brepocitinib or a placebo once daily. The study will include adults aged 18 to 75 years who have active disease in at least one eye and meet specific health criteria. The goal is to determine if brepocitinib can provide a beneficial treatment option for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 with a diagnosis of active non-infectious uveitis.
Not a fit: Patients with infectious uveitis or those with certain recent health issues, such as malignancies or active infections, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with non-infectious uveitis, potentially improving their quality of life.
How similar studies have performed: Other studies have explored treatments for uveitis, but the specific use of brepocitinib in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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: 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 orand cerebrovascularardiovascular ischemic event disease within the last 12 months 5. a high risk for herpes zoster reactivation 6. active or recent infections
Where this trial is running
Phoenix, Arizona and 39 other locations
- Clinical Trial Site — Phoenix, Arizona, United States (Recruiting)
- Clinical Trial Site — Bakersfield, California, United States (Recruiting)
- Clinical Trial Site — Beverly Hills, California, United States (Recruiting)
- Clinical Trial Site — Fullerton, California, United States (Recruiting)
- Clinical Trial Site — Irvine, California, United States (Recruiting)
- Clinical Trial Site — La Jolla, California, United States (Recruiting)
- Clinical Trial Site — Los Angeles, California, United States (Recruiting)
- Clinical Trial Site — Los Angeles, California, United States (Recruiting)
- Clinical Trial Site — Modesto, California, United States (Recruiting)
- Clinical Trial Site — Sacramento, California, United States (Recruiting)
- Clinical Trial Site — Aurora, Colorado, United States (Recruiting)
- Clinical Trial Site — Fort Lauderdale, Florida, United States (Recruiting)
- Clinical Trial Site — Saint Petersburg, Florida, United States (Recruiting)
- Clinical Trial Site — Carmel, Indiana, United States (Recruiting)
- Clinical Trial Site — Boston, Massachusetts, United States (Recruiting)
- Clinical Trial Site — Waltham, Massachusetts, United States (Recruiting)
- Clinical Trial Site — Ann Arbor, Michigan, United States (Recruiting)
- Clinical Trial Site — Detroit, Michigan, United States (Recruiting)
- Clinical Trial Site — Minneapolis, Minnesota, United States (Recruiting)
- Clinical Trial Site — Rochester, Minnesota, United States (Recruiting)
- Clinical Trial Site — Saint Louis, Missouri, United States (Recruiting)
- Clinical Trial Site — Omaha, Nebraska, United States (Recruiting)
- Clinical Trial Site — Palisades Park, New Jersey, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
- Clinical Trial Site — Durham, North Carolina, United States (Recruiting)
- Clinical Trial Site — Cleveland, Ohio, United States (Recruiting)
- Clinical Trial Site — Portland, Oregon, United States (Recruiting)
- Clinical Trial Site — Portland, Oregon, United States (Recruiting)
- Clinical Trial Site — Erie, Pennsylvania, United States (Recruiting)
- Clinical Trial Site — Philadelphia, Pennsylvania, United States (Recruiting)
- Clinical Trial Site — Philadelphia, Pennsylvania, United States (Recruiting)
- Clinical Trial Site — Nashville, Tennessee, United States (Recruiting)
- Clinical Trial Site — Austin, Texas, United States (Recruiting)
- Clinical Trial Site — Bellaire, Texas, United States (Recruiting)
- Clinical Trial Site — Dallas, Texas, United States (Recruiting)
- Clinical Trial Site — Houston, Texas, United States (Recruiting)
- Clinical Trial Site — Katy, Texas, United States (Recruiting)
- Clinical Trial Site — Plano, Texas, United States (Recruiting)
- Clinical Trial Site — Round Rock, Texas, United States (Recruiting)
- Clinical Trial Site — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trial Administrator
- Email: clinicaltrials@priovanttx.com
- Phone: (212) 634-9743
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.