Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      -  180 patients suffering from active Crohn's disease with evidence of mucosal ulceration
           will be evaluated for improvement of disease activity (efficacy) when taking GLPG0634 or
           matching placebo once daily for 20 weeks in addition to their stable background
           treatment.

        -  During the course of the study, patients will also be examined for any side effects that
           may occur (safety and tolerability), and the amount of GLPG0634 present in the blood
           (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of
           action-related parameters in the blood and stool (Pharmacodynamics) will be determined.
           Also, the effects GLPG0634 administration on subjects' quality of life will be
           evaluated.
    

Detailed description: 
      -  180 patients suffering from active Crohn's disease with evidence of mucosal ulceration
           will be evaluated when taking GLPG0634 or matching placebo once daily in addition to
           their stable background treatment. The population will include 50% anti-TNF naïve
           patients and 50% of subjects previously exposed to anti-TNF.

        -  The study will consist of 2 parts, with total treatment duration of 20 weeks.
           Randomisation in Part 1 will be stratified according to subject's previous anti-TNF
           exposure, C-reactive protein (CRP) level at Screening and oral corticosteroid use at Day
           -1. However, at Week 10, subjects will be re-randomized automatically and stratified
           according to the subject's clinical response (reduction of Crohn's Disease Activity
           Index (CDAI) of 100 points), previous anti-TNF exposure and corticosteroid use at Day -1
           to receive GLPG0634 200 mg q.d., 100 mg q.d. doses, or matching placebo q.d. in a
           blinded fashion. In Part 2, all will continue the study until Week 20.

        -  As efficacy parameters, the ability to achieve clinical response or remission,
           endoscopic response & remission as well as mucosal healing with GLPG0634 given once
           daily compared to placebo will be evaluated after 10 weeks of treatment. In subjects who
           achieved clinical remission at Week 10, maintenance of the remission will be assessed
           during Part 2 of the study.

        -  During the course of the study, patients will also be examined for any side effects that
           may occur (safety and tolerability), and the amount of GLPG0634 present in the blood
           (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of
           action-related parameters in the blood and stool (Pharmacodynamics) will be determined.
           Also, the effects of different doses and dose regimens of GLPG0634 administration on
           subjects' quality of life will be evaluated.
    

Intervention name(s): GLPG0634; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg oral tablet, intake once daily for 20 weeks; placebo oral tablets, intake once daily for 20 weeks
Other intervention name(s): GLPG0634 tablets; Placebo tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Active Crohn's Disease; GLPG0634