A Clinical Trial Of Tulisokibart In Participants With Active, Non-Infectious Uveitis (MK-7240-019)
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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
This study consists of a 50-week Double-blind Period and a 134-week Long-term Extension.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- Fase 2
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Experimental: Tulisokibart Low Dose
Participants receive background therapy of prednisone plus a high dose of tulisokibart. |
Subcutaneous (SC) administration
Otros nombres:
Oral administration |
|
Experimental: Tulisokibart High Dose
Participants receive background therapy of prednisone plus a low dose of tulisokibart. |
Subcutaneous (SC) administration
Otros nombres:
Oral administration |
|
Comparador de placebos: Placebo
Participants receive background therapy of prednisone plus placebo to tulisokibart. |
SC administration Oral administration |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to Treatment Failure Occurring on or After Week 6 Through Week 50
Periodo de tiempo: 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. |
up to 44 weeks
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants with Treatment Failure Occurring on or After Week 6 Through Week 26
Periodo de tiempo: Up to 20 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 mat. The percentage of participants with treatment failure treatment failure occurring on or after Week 6 through Week 26 will be reported. |
Up to 20 weeks
|
|
Mean Change in Vitreous Haze (VH) Grade from Best State Achieved Prior to Week 6 up to Week 50
Periodo de tiempo: Baseline and 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. |
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
Periodo de tiempo: Baseline and 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. |
Baseline and up to Week 26
|
|
Number of Participants Who Experience One or More Adverse Events (AEs)
Periodo de tiempo: Up to 198 weeks
|
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. |
Up to 198 weeks
|
|
Number of Participants Who Discontinue Study Intervention Due to an AE
Periodo de tiempo: Up to 184 weeks
|
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. |
Up to 184 weeks
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Director de estudio: Medical Director, Merck Sharp & Dohme LLC
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 7240-019
- 2025 (Subvención/contrato del NIH de EE. UU.)
- U1111-1329-4205 (Identificador de registro: UTN)
- 2025-524059-30-00 (Identificador de registro: EU CT)
- MK-7240-019 (Otro identificador: MSD)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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