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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
This study consists of a 50-week Double-blind Period and a 134-week Long-term Extension.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Tulisokibart Low Dose
Participants receive background therapy of prednisone plus a high dose of tulisokibart. |
Subcutaneous (SC) administration
Ostatní jména:
Oral administration |
|
Experimentální: Tulisokibart High Dose
Participants receive background therapy of prednisone plus a low dose of tulisokibart. |
Subcutaneous (SC) administration
Ostatní jména:
Oral administration |
|
Komparátor placeba: Placebo
Participants receive background therapy of prednisone plus placebo to tulisokibart. |
SC administration Oral administration |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to Treatment Failure Occurring on or After Week 6 Through Week 50
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of Participants with Treatment Failure Occurring on or After Week 6 Through Week 26
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Medical Director, Merck Sharp & Dohme LLC
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 7240-019
- 2025 (Grant/smlouva NIH USA)
- U1111-1329-4205 (Identifikátor registru: UTN)
- 2025-524059-30-00 (Identifikátor registru: EU CT)
- MK-7240-019 (Jiný identifikátor: MSD)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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