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This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with active intermediate, posterior, or pan non-infectious uveitis (NIU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brepocitinib Dose Level 1 by mouth (PO) once daily (QD) | Experimental |
| |
| Brepocitinib Dose Level 2 by mouth (PO) once daily (QD) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brepocitinib | Drug | Oral Brepocitinib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Safety assessments will consist of monitoring and recording all adverse events (AEs) and SAEs, laboratory evaluation for hematology, blood chemistry, and urinalysis; vital signs; electrocardiograms (ECGs); and physical examinations. The investigator will determine whether the change is clinically meaningful. | Screening up to 28 days after the last dose of study drug at 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants meeting treatment failure criteria on or after Week 6 up to Week 24 | 24 weeks |
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Inclusion Criteria:
Adult subjects (18-74 years old)
Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis).
Active uveitic disease as defined by the presence of at least 1 of the following parameters in at least 1 eye, as determined by the investigator:
Receiving up to one non-corticosteroid, non-biologic, immunomodulatory therapy
Weight > 40 kg with a body mass index < 40 kg/m2.
Exclusion Criteria:
Has isolated anterior uveitis.
Has confirmed or suspected current diagnosis of infectious uveitis
History of:
At risk of thrombosis and cardiovascular disease
Have a high risk for herpes zoster reactivation
Have active or recent infections
Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Brendan Johnson, PhD | SVP, Early Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Los Angeles | California | 90095 | United States | ||
| Clinical Trial Site |
Priovant Therapeutics will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) from eligible studies upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Data requests will be reviewed and approved on the basis of scientific merit.
The data will be made available within 24 months after study completion and will be accessible for a time frame appropriate for the approved proposal.
Access will be provided following review and approval of a research proposal and execution of a Data Sharing Agreement (DSA). Further details on Priovant Therapeutics' data sharing criteria and process for requesting access can be obtained by emailing info@priovanttx.com.
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| Palo Alto |
| California |
| 94303 |
| United States |
| Clinical Trial Site | Pasadena | California | 91107 | United States |
| Clinical Trial Site | Lakewood | Colorado | 80228 | United States |
| Clinical Trial Site | Waltham | Massachusetts | 02451 | United States |
| Clinical Trial Site | St Louis | Missouri | 63110 | United States |
| Clinical Trial Site | Palisades Park | New Jersey | 07650 | United States |
| Clinical Trial Site | Durham | North Carolina | 27710 | United States |
| Clinical Trial Site | Winston-Salem | North Carolina | 27157 | United States |
| Clinical Trial Site | Eugene | Oregon | 97401 | United States |
| Clinical Trial Site | Nashville | Tennessee | 37203 | United States |
| Clinical Trial Site | Bellaire | Texas | 77401 | United States |
| Clinical Trial Site | Katy | Texas | 77494 | United States |
| Clinical Trial Site | Plano | Texas | 75075 | United States |
| Clinical Trial Site | Salt Lake City | Utah | 84107 | United States |
| ID | Term |
|---|---|
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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