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

NCT07861074 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 5 other identifiers: 7240-019U1111-1329-42052025-524059-30-00MK-7240-0192025
• Study Type: interventional
• Target: 87
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Time to Treatment Failure Occurring on or After Week 6 Through Week 50

  The time to treatment failure is the interval from the date of first study dose intervention to the earliest assessment date on which any protocol-specified treatment failure criterion is met. The time to treatment failure occurring on or after Week 6 through Week 50 will be reported.

  up to 44 weeks

Secondary Outcomes (5)

• Percentage of Participants with Treatment Failure Occurring on or After Week 6 Through Week 26

  Up to 20 weeks

• Mean Change in Vitreous Haze (VH) Grade from Best State Achieved Prior to Week 6 up to Week 50

  Baseline and up to Week 50

• Mean Change in Logarithm of the Minimal Angle of Resolution Best Corrected Visual Acuity (BCVA) from Best State Achieved Prior to Week 6 up to Week 26

  Baseline and up to Week 26

• Number of Participants Who Experience One or More Adverse Events (AEs)

  Up to 198 weeks

• Number of Participants Who Discontinue Study Intervention Due to an AE

  Up to 184 weeks

Study Arms (3)

Tulisokibart Low Dose

EXPERIMENTAL

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

Drug: Tulisokibart; Drug: Background prednisone therapy

Tulisokibart High Dose

EXPERIMENTAL

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

Drug: Tulisokibart; Drug: Background prednisone therapy

Placebo

PLACEBO COMPARATOR

Participants receive background therapy of prednisone plus placebo to tulisokibart.

Drug: Placebo; Drug: Background prednisone therapy

Interventions

Tulisokibart DRUG

Subcutaneous (SC) administration

Also known as: MK-7240, PRA023

Tulisokibart High Dose; Tulisokibart Low Dose

Placebo DRUG

SC administration

Placebo

Background prednisone therapy DRUG

Oral administration

Placebo; Tulisokibart High Dose; Tulisokibart Low Dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Panuveitis

Condition Hierarchy (Ancestors)

Uveitis; Uveal Diseases; Eye Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2026
• First Posted: October 6, 2026
• Study Start (Estimated): October 27, 2026
• Primary Completion (Estimated): June 5, 2029
• Study Completion (Estimated): April 6, 2032
• Last Updated: October 6, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share