A Phase 3 Study of Brepocitinib in Adults with Active, Non-Infectious, Non-Anterior Uveitis (CLARITY)

Phase 3

Not yet recruiting

• Conditions: active non-infectious uveitis (intermediate uveitis, posterior uveitis, panuveitis)
• Interventions: Drug: brepocitinib

• Registration Number: 2024-515089-15-00
• Lead Sponsor: Priovant Therapeutics Inc.

Brief Summary

To evaluate the efficacy of brepocitinib in participants with non-infectious intermediate uveitis, posterior uveitis, and panuveitis

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-02-25
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 105

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 or cerebrovascular ischemic event within the last 12 months; - a high risk for herpes zoster reactivation; - active or recent infections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
brepocitinib	brepocitinib	Participants receiving brepocitinib

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Proportion of participants meeting treatment failure criteria on or after Period 1 Week 6 up to Period 1 Week 24		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 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 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 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		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

Trial Locations

Locations (32)

Johannes Kepler University Linz; 🇦🇹 Linz, Austria

Medical University Of Vienna; 🇦🇹 Vienna, Austria

UZ Leuven; 🇧🇪 Leuven, Belgium

Vseobecna Fakultni Nemocnice V Praze; 🇨🇿 Prague, Czechia

Augenzentrum Am St Franziskus-Hospital Muenster; 🇩🇪 Munster, Germany

Universitaetsklinikum Tuebingen AöR; 🇩🇪 Tuebingen, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR; 🇩🇪 Mainz, Germany

Heidelberg University; 🇩🇪 Mannheim, Germany

Medical Center - University Of Freiburg; 🇩🇪 Freiburg Im Breisgau, Germany

Universitaet Muenster; 🇩🇪 Muenster, Germany

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Johannes Kepler University Linz

🇦🇹Linz, Austria

Matthias Bolz

Site contact

+43732780678409

matthias.bolz@kepleruniklinikum.at