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Recruiting

Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease - RPC01-3201

Actualizada: 28 febrero, 2021   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 3

    Fase

  • Géneros

  • 12-75

    Rango de edad

  • 185

    Ubicación (es)

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Administration of oral Ozanimod
Drug: Ozanimod
Placebo Comparator: Administration of Placebo
Other: Placebo

Criterios clave de elegibilidad

Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Aged 12-75 years 2. Crohn's disease for ≥ 3 months on endoscopy and on histological exam 3. Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy 4. Patient has met each of the following clinical and endoscopic criteria: 1. Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450. 2. Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points. 3. SES-CD score of ≥ 6 (or SES-CD ≥ 4 in subjects with isolated ileal disease). Exclusion Criteria: The presence of any of the following will exclude a subject from enrollment or at the time point specified in the following criteria: 1. Subject has a diagnosis of UC, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation, requiring procedural intervention, or with obstructive symptoms. In addition, subjects with colonic or ileal strictures that are not passable with an age-appropriate colonoscope that the endoscopist normally uses in clinical practice, or strictures in the ileum or ileocecal valve that are fibrotic in nature, will be excluded. 2. Current stoma, ileal-anal pouch anastomosis, fistula that is likely to require, in the physician's judgement, surgical or medical intervention within 12 weeks of entry into the study, or need for ileostomy or colostomy.

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Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

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Llame 855-907-3286 o Envíenos un correo electrónico