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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
This study consists of a 50-week Double-blind Period and a 134-week Long-term Extension.
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Fase 2
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: Tulisokibart Low Dose
Participants receive background therapy of prednisone plus a high dose of tulisokibart. |
Subcutaneous (SC) administration
Altri nomi:
Oral administration |
|
Sperimentale: Tulisokibart High Dose
Participants receive background therapy of prednisone plus a low dose of tulisokibart. |
Subcutaneous (SC) administration
Altri nomi:
Oral administration |
|
Comparatore placebo: Placebo
Participants receive background therapy of prednisone plus placebo to tulisokibart. |
SC administration Oral administration |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Time to Treatment Failure Occurring on or After Week 6 Through Week 50
Lasso di tempo: 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
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants with Treatment Failure Occurring on or After Week 6 Through Week 26
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: Medical Director, Merck Sharp & Dohme LLC
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 7240-019
- 2025 (Sovvenzione/contratto NIH degli Stati Uniti)
- U1111-1329-4205 (Identificatore di registro: UTN)
- 2025-524059-30-00 (Identificatore di registro: EU CT)
- MK-7240-019 (Altro identificatore: MSD)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informazioni su farmaci e dispositivi, documenti di studio
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