A Clinical Trial Of Tulisokibart In Participants With Active, Non-Infectious Uveitis (MK-7240-019)

Ki vehet részt

• The main inclusion criteria include but are not limited to the following:
• Has active noninfectious intermediate uveitis, posterior uveitis, or panuveitis (NIIPPU) at screening and baseline in at least one eye
• Meets prior stable dose and duration requirements before baseline for permitted immunosuppressive therapies and corticosteroids

Ki nem vehet részt

• Has planned ocular surgery during the double-masked treatment period
• Has had recent ocular surgery or ocular laser procedure that could affect study assessments
• Has had major surgery within 3 months prior to Screening or has major surgery planned during the study
• Has demonstrated intolerance to or prior inadequate response to high-dose oral corticosteroids for the study indication
• Has active ocular disease that may confound assessment or is not adequately controlled
• Has any condition preventing evaluation of both eyes for eligibility or efficacy assessments
• Has any other immune-mediated inflammatory condition that is not well controlled and may require prohibited therapy
• Has active infection
• Has a recent history of malignancy that is not considered adequately resolved
• Has had a recent diagnostic evaluation for malignancy where malignancy cannot be reasonably excluded
• Has known allergies, hypersensitivity, or intolerance to the study drug and other medications, dyes
• The main exclusion criteria include but are not limited to the following:
• Has isolated anterior uveitis
• Has macular edema as the only sign of intermediate, posterior, or panuveitis
• Has significant ocular comorbidity that would interfere with visualization or study assessments
• Has a contraindication to mydriatic eye drops or cannot be adequately dilated for fundus - visualization
• Has a transplanted organ requiring continued systemic immunosuppression