A Clinical Trial Of Tulisokibart In Participants With Active, Non-Infectious Uveitis (MK-7240-019)
Key facts
- Who runs it
- Merck Sharp & Dohme LLC
- Where
- Plano, United StatesSee the site
- Trial code
- NCT07861074
- EU 2025-524059-30-00
- U1111-1329-4205
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 87 people, planned
- Started
- 4 Nov 2026
- Expected to end
- 10 Apr 2032
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Tulisokibart
- Placebo
- Background prednisone therapy
- Record updated
- 9 November 2026
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in United States
- Texas Retina Associates (Site 0006)Plano, United StatesContact: Study CoordinatorTaking people
About the trial
What the trial wants to find out
This trial will help researchers learn if tulisokibart, the trial medicine, can treat non-infectious intermediate, posterior, or panuveitis (NIIPPU) so that steroids can be given for a shorter period of time. In this trial, researchers will look at different doses (amounts) of tulisokibart.
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The goal of this trial is to learn if tulisokibart works better than placebo to increase the length of time until NIIPPU gets worse. A placebo looks like the trial medicine but has no medicine in it. Using a placebo helps researchers better understand the effects of the trial medicine.
The 3 groups in the trial
- Tulisokibart Low DoseTreatment being tested
Participants receive background therapy of prednisone plus a high dose of tulisokibart.
Treatment: Tulisokibart and Background prednisone therapy
- Tulisokibart High DoseTreatment being tested
Participants receive background therapy of prednisone plus a low dose of tulisokibart.
Treatment: Tulisokibart and Background prednisone therapy
- PlaceboPlacebo, for comparison
Participants receive background therapy of prednisone plus placebo to tulisokibart.
Treatment: Placebo and Background prednisone therapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 2b, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Active Noninfectious Intermediate, Posterior, or Panuveitis
- Fit questions
- Built from NCT07861074, who can take part
- Record updated
- 9 November 2026