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A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease



Short title: GALAXI

Investigated disease: Morbus Crohn

Principal Investigator: Dr. med. Anja Schirbel


Clinic, Institute: Medizinische Klinik m.S. Hepatologie und Gastroenterologie CCM

Patient (diseased)
Age: 18 - 80
Gender: All

Status: Participants wanted
Last change: 22.09.2021

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Study Description

Title

A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

Short title

GALAXI

General Short Description

Eine multizentrische, randomisierte, doppelblinde, Placebo- und wirkstoffkontrollierte Parallelgruppenstudie der Phase II/III zur Beurteilung der Wirksamkeit und Sicherheit von Guselkumab bei Teilnehmern mit mittelgradig bis stark aktivem Morbus Crohn

Scientific Short Description

A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

EudraCT-No.

2017-002195-13

Investigated Disease, Health Issue

ICD-Code
  • K50 - Crohn-Krankheit [Enteritis regionalis] [Morbus Crohn]

Inclusion Criteria

Age

18 - 80

Gender

All

Additional Inclusion Criteria

mäßig bis stark aktiver Morbus Crohn seit mindestens drei Monaten, CDAI 220 - 450, kein Ansprechen auf vorherige Behandlung

Exclusion Criteria

Komplikationen wie Verengungen im Darm, Kurzdarmsyndrom, Abszess, Stoma, Infektionen

Characteristics

Studytype

Interventional

Studyphase

2-3

Contact

Contact for Study Participants

Marika Saegebarth

+49 (0)30 450 614 096

marika.saegebarth(at)charite.de


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