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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06431373
Other study ID # PVT-2201-303
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date August 23, 2024
Est. completion date August 23, 2027

Study information

Verified date May 2024
Source Priovant Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Brepocitinib PO QD
Brepocitinib PO QD
Placebo PO QD
Placebo PO QD

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Priovant Therapeutics, Inc.

Outcome

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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