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

Overview

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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: Active, inflammatory chorioretinal and/or retinal vascular lesion; OR ≥2+ vitreous haze grade (NEI/SUN criteria).
-Weight > 40 kg with a body mass index < 40 kg/m2.

Exclusion Criteria:

-Has isolated anterior uveitis.
-Has macular edema as the only sign of intermediate uveitis, posterior uveitis, or panuveitis.
-Has confirmed or suspected current diagnosis of infectious uveitis
-History of or have:
1. ymphoproliferative 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/6/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Wendy Smith, M.D.

Open for enrollment

Contact information:

Bridgette Halder C.O.A.

(507) 422-2780

Halder.Bridgette@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Alexander Shusko, M.D.

Contact us for the latest status

Contact information:

Aubrey Smith M.S.

(480) 301-6104

Smith.Aubrey@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20574438

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