Extension Study of MT-1303 in Subjects With Crohn's Disease

A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease Who Have Completed the MT 1303-E13 Study

Patrocinadores

Patrocinador principal: Mitsubishi Tanabe Pharma Corporation

Fuente Mitsubishi Tanabe Pharma Corporation
Resumen breve

The primary objectives of the study are:

-To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease(CD)

Estado general Completed
Fecha de inicio August 2015
Fecha de Terminación August 2017
Fecha de finalización primaria August 2017
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Number of Subjects with Adverse Events 36 weeks
Inscripción 46
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: MT-1303

Etiqueta de grupo de brazo: MT-1303

Elegibilidad

Criterios:

Inclusion Criteria:

- The subject completed 14 week Treatment Period in the double blind MT-1303-E13 study as per Protocol.

Exclusion Criteria:

- Permanent discontinuation of study medication prior to the end of treatment Visit in MT-1303-E13

Género: All

Edad mínima: 18 Years

Edad máxima: 65 Years

Voluntarios Saludables: No

Ubicación
Instalaciones:
Investigational site | City Name, Czechia
Investigational site | City Name, France
Investigational site | City Nmae, Germany
Investigational site | City Nmae, Hungary
Investigational site | City Name, Israel
Investigational site | City Name, Italy
Investigational site | City Nmae, Japan
Investigational site | City Name, Netherlands
Investigational site | City Name, Poland
Investigational site | City Name, Slovakia
Investigational site | City Name, Ukraine
Ubicacion Paises

Czechia

France

Germany

Hungary

Israel

Italy

Japan

Netherlands

Poland

Slovakia

Ukraine

Fecha de verificación

September 2017

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 1
Grupo de brazo

Etiqueta: MT-1303

Tipo: Experimental

Información de diseño del estudio

Asignación: N/A

Modelo de intervención: Single Group Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov