Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

TerminadoFase 3ClinicalTrials.gov

ID: NCT03440372Tipo: INTERVENTIONALInicio: 27 de feb de 2018Fin estimado: 1 de oct de 2024

Traducción no disponible, mostrando original

Resumen

This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Crohn's disease for ≥ 3 months on endoscopy and on histological exam
Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapies
Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
An average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
Has Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)

Criterios de exclusión

Has a diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
Has extensive small bowel resection (\>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition
Current stoma, ileal-anal pouch anastomosis, or fistula

Intervenciones

drug

Ozanimod

Specified dose on specified days

other

Placebo

Specified dose on specified days

Ubicaciones

Local Institution - 501

Buenos Aires, Argentina

Local Institution - 494

Buenos Aires, Argentina

Local Institution - 571

Buenos Aires, Argentina

Local Institution - 500

Buenos Aires, Argentina

Local Institution - 570

Córdoba, Argentina

Local Institution - 495

Córdoba, Argentina

Local Institution - 569

Mar del Plata, Argentina

Local Institution - 496

Rosario, Argentina

Local Institution - 497

Rosario, Argentina

Local Institution - 502

Rosario, Santa Fe, Argentina

Local Institution - 492

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalCelgene

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