A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis

Uveitis Clinical Trial

— CLARITY  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06431373
• Other study ID #: PVT-2201-303
• Status: Not yet recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Uveitis
• Uveitis, Intermediate
• Uveitis, Posterior

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