Noninfectious Intermediate, Posterior, or PanuveitisPhase 2NCT07861074
A Clinical Trial Of Tulisokibart In Participants With Active, Non-Infectious Uveitis (MK-7240-019)
A Phase 2 study testing Tulisokibart and Background prednisone therapy in people with Noninfectious Intermediate, Posterior, or Panuveitis, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Noninfectious Intermediate, Posterior, or Panuveitis
- What is being tested?
- Tulisokibart and Background prednisone therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- 27 Oct 2026to 6 Apr 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
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- 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
About this study
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
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.
Read the detailed description
This study consists of a 50-week Double-blind Period and a 134-week Long-term Extension.
- Being tested
- Tulisokibart, Placebo, Background prednisone therapy
- Medical subject headings
- Panuveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TulisokibartDrug
Also called MK-7240, PRA023
Subcutaneous (SC) administration
PlaceboDrug
SC administration
Background prednisone therapyDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Tulisokibart Low Dose | Experimental | Participants receive background therapy of prednisone plus a high dose of tulisokibart. Receives: Drug: Tulisokibart; Drug: Background prednisone therapy |
| Tulisokibart High Dose | Experimental | Participants receive background therapy of prednisone plus a low dose of tulisokibart. Receives: Drug: Tulisokibart; Drug: Background prednisone therapy |
| Placebo | Placebo comparator | Participants receive background therapy of prednisone plus placebo to tulisokibart. Receives: Drug: Placebo; Drug: Background prednisone therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 44 weeks
Secondary outcomes (5)
Percentage of Participants with Treatment Failure Occurring on or After Week 6 Through Week 26
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 mat. The percentage of participants with treatment failure treatment failure occurring on or after Week 6 through Week 26 will be reported.
Measured: Up to 20 weeks
Mean Change in Vitreous Haze (VH) Grade from Best State Achieved Prior to Week 6 up to Week 50
VH Grade will be assessed by dilated indirect ophthalmoscopy in accordance with the National Eye Institute/ Standardization of Uveitis Nomenclature criteria with grades ranging from 0 (no evident vitreal haze) to 4+ (optic nerve head is obscured) with a higher grade indicating a greater amount of VH. The mean change in VH grade from best state achieved prior to Week 6 up to Week 50 will be reported.
Measured: 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
Refraction will be performed in the participant's study eye, and using the appropriate corrective lenses, BRCA will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity. The BCVA scores will be converted to a log scale and reported as the logarithm of the minimal angle of resolution (logMAR) BCVA. The mean change from best state achieved prior to Week 6 up to Week 26 will be reported.
Measured: Baseline and up to Week 26
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experience AEs will be reported.
Measured: Up to 198 weeks
Number of Participants Who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinue study intervention due to an AE will be reported.
Measured: Up to 184 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start27 Oct 2026 (estimated)
- Primary completion5 Jun 2029 (estimated)
- Study completion6 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noninfectious Intermediate, Posterior, or PanuveitisStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861074
- Sponsor's protocol ID
- 7240-019
- Other IDs
- U1111-1329-4205, 2025-524059-30-00, MK-7240-019, 2025
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07861074
- Acronym / sponsor ID
- 7240-019
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2026 (estimated)
- Primary completion
- 5 Jun 2029 (estimated)
- Study completion
- 6 Apr 2032 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study consists of a 50-week Double-blind Period and a 134-week Long-term Extension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tulisokibart Low Dose | Experimental | Drug: Tulisokibart, Drug: Background prednisone therapyParticipants receive background therapy of prednisone plus a high dose of tulisokibart. |
| Tulisokibart High Dose | Experimental | Drug: Tulisokibart, Drug: Background prednisone therapyParticipants receive background therapy of prednisone plus a low dose of tulisokibart. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Background prednisone therapyParticipants receive background therapy of prednisone plus placebo to tulisokibart. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TulisokibartAlso: MK-7240, PRA023Subcutaneous (SC) administration | Drug | Tulisokibart High Dose, Tulisokibart Low Dose |
| PlaceboSC administration | Drug | Placebo |
| Background prednisone therapyOral administration | Drug | Placebo, Tulisokibart High Dose, Tulisokibart Low Dose |
Primary outcome
Time to Treatment Failure Occurring on or After Week 6 Through Week 50
Time frame: up to 44 weeks
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.
5 secondary outcomes
Percentage of Participants with Treatment Failure Occurring on or After Week 6 Through Week 26
Time frame: Up to 20 weeks
Mean Change in Vitreous Haze (VH) Grade from Best State Achieved Prior to Week 6 up to Week 50
Time frame: 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
Time frame: Baseline and up to Week 26
Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to 198 weeks
Number of Participants Who Discontinue Study Intervention Due to an AE
Time frame: Up to 184 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tulisokibart and Background prednisone therapy in people with Noninfectious Intermediate, Posterior, or Panuveitis, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Treatment Failure Occurring on or After Week 6 Through Week 50 (time frame: up to 44 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.