This study will run in centers in Germany, Denmark, Austria, Czech Republic, and Switzerland, only. This proof-of-concept study aims to evaluate the efficacy of three doses of oral TSO suspension vs. placebo for the induction of remission in Crohn's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
254
Low dose TSO suspension
Medium dose TSO suspension
High dose TSO suspension
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt a.M., Hesse, Germany
Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150
Time frame: 12 weeks
Reduction of > 100 points in CDAI
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
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Placebo solution