A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease

Update Il y a 4 ans
Reference: EUCTR2016-001367-36

Woman and Man

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Extract

The primary objectives of Cohort A Induction Study are: • To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical remission by Patient Reported Outcomes (PRO2) at Week 10 • To evaluate the efficacy of filgotinib as compared to placebo in establishing endoscopic response at Week 10 The primary objectives of Cohort B Induction Study are: • To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical remission by PRO2 at Week 10 • To evaluate the efficacy of filgotinib as compared to placebo in establishing endoscopic response at Week 10 The primary objectives of the Maintenance Study are: • To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical remission by PRO2 at Week 58 • To evaluate the efficacy of filgotinib as compared to placebo in establishing endoscopic response at Week 58


Inclusion criteria

  • Moderately to Severely Active Crohn's Disease (CD)