Recruiting
Phase 2

Tulisokibart

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07861074

Conditions

Noninfectious Intermediate, Posterior, or Panuveitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tulisokibart

Placebo

Background prednisone therapy

Study Details

Brief summary:

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.

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.

Conditions

Noninfectious Intermediate, Posterior, or Panuveitis

Study ID

NCT07861074

Start date

Nov 4, 2026

Status verified date

Nov, 2026

Completion date

Apr 10, 2032

Anticipated

Primary completion date

Jun 5, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

87 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tulisokibart Low Dose

Participants receive background therapy of prednisone plus a high dose of tulisokibart.

experimental: Tulisokibart High Dose

Participants receive background therapy of prednisone plus a low dose of tulisokibart.

placebo comparator: Placebo

Participants receive background therapy of prednisone plus placebo to tulisokibart.

Interventions

Tulisokibart

Subcutaneous (SC) administration

Placebo

SC administration

Background prednisone therapy

Oral administration

Primary outcome measure

  • Time to Treatment Failure Occurring on or After Week 6 Through Week 50 [ Time Frame: up to 44 weeks ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Texas Retina Associates ( Site 0006)

Recruiting

Plano, Texas, United States, 75075

Contacts

Study Coordinator

214-706-0438

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Nov 9, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-10. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-11-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.