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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515089-15-00
Acronym
PVT-2201-303
Enrollment
105
Registered
2025-02-25
Start date
2025-02-28
Completion date
Unknown
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

active non-infectious uveitis (intermediate uveitis, posterior uveitis, panuveitis)

Brief summary

Time to treatment failure on or after Period 1 Week 6 up to Period 1 Week 48

Detailed description

Proportion of participants meeting treatment failure criteria on or after Period 1 Week 6 up to Period 1 Week 24, Change in logarithm of the minimum angle of resolution (logMAR) best corrected visual acuity (BCVA) in each eye from best state achieved at or prior to Period 1 Week 6 up to Period 1 Week 24;, Change in central subfield thickness from best state achieved in each eye at or prior to Period 1 Week 6 up to Period 1 Week 24, Change in logMAR BCVA in each eye from best state achieved at or prior to Period 1 Week 6 up to Period 1 Week 48, Change in central subfield thickness from best state achieved in each eye at or prior to Period 1 Week 6 up to Period 1 Week 48

Interventions

DRUGPlacebo tablet to match 45 mg brepocitinib tablet.

Sponsors

Priovant Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to treatment failure on or after Period 1 Week 6 up to Period 1 Week 48

Secondary

MeasureTime frame
Proportion of participants meeting treatment failure criteria on or after Period 1 Week 6 up to Period 1 Week 24, Change in logarithm of the minimum angle of resolution (logMAR) best corrected visual acuity (BCVA) in each eye from best state achieved at or prior to Period 1 Week 6 up to Period 1 Week 24;, Change in central subfield thickness from best state achieved in each eye at or prior to Period 1 Week 6 up to Period 1 Week 24, Change in logMAR BCVA in each eye from best state achieved at or prior to Period 1 Week 6 up to Period 1 Week 48, Change in central subfield thickness from best state achieved in each eye at or prior to Period 1 Week 6 up to Period 1 Week 48

Countries

Austria, Belgium, Czechia, Germany, Greece, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026