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Klinische Studien von BMS suchen
BMS-Symbol für "Aktive Studie, für die noch nicht rekrutiert wird"

Active, Not Recruiting

Studien-Nr. IM047-029  |   NCT05369832

An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice

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In diese Studie werden leider keine neuen Patient:innen aufgenommen, sie ist aber weiterhin aktiv.
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Zusammenfassung

  • Phase 4
  • Symbol für männliches und weibliches Geschlecht
  • 18+
    Altersgruppe
  • BMS-Symbol für "Aktive Studie, für die noch nicht rekrutiert wird"
    Active, Not Recruiting

Überblick

The purpose of this study is to explore the safety, efficacy, quality of life, and biomarker response in participants with moderate to severe ulcerative colitis in clinical practice.

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Wichtigste Einschlusskriterien

Inclusion Criteria: - A diagnosis of ulcerative colitis (UC), with signs and symptoms consistent with UC for at least 3 months prior to the first study intervention administration - Moderate to severely active UC disease activity defined as a modified Mayo score of 5 through 9, inclusive - Report of a previous colonoscopy that documents extent of disease Exclusion Criteria: - Current or recent (within 3 months of screening) evidence of fulminant colitis, toxic megacolon, or bowel perforation - Extensive colonic resection or current stoma - Colonic dysplasia that has not been removed Other protocol-defined inclusion/exclusion criteria apply

Behandlungsmöglichkeiten

Studienarme

ZUGEWIESENE BEHANDLUNG

Studienarme

Experimental: Cohort 1 - Advanced therapy-naive

ZUGEWIESENE BEHANDLUNG
  • Drug: Ozanimod

Studienarme

Experimental: Cohort 2 - Advanced therapy-exposed

ZUGEWIESENE BEHANDLUNG
  • Drug: Ozanimod

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