Tulisokibart for non-infectious uveitis in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 study evaluates different doses of tulisokibart for non-infectious intermediate, posterior, or panuveitis over a 50-week double-blind period followed by a 134-week long-term extension. Participants are randomized to receive tulisokibart or placebo, along with background prednisone therapy as needed. The goal is to determine whether tulisokibart can prolong stability and reduce steroid exposure. Safety and efficacy will be monitored through scheduled visits and eye exams.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

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 active ocular disease that may confound assessment or is not adequately controlled
* Has significant ocular comorbidity that would interfere with visualization or study assessments
* 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 a contraindication to mydriatic eye drops or cannot be adequately dilated for fundus - visualization
* 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 a transplanted organ requiring continued systemic immunosuppression
* 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 demonstrated intolerance to or prior inadequate response to high-dose oral corticosteroids for the study indication
* Has known allergies, hypersensitivity, or intolerance to the study drug and other medications, dyes

Where it's running

• Texas Retina Associates ( Site 0006)
  Plano, Texas, United States Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.