The participation in this clinical study will last approximately 21 weeks with a 1 week screening period and a 12 weeks treatment duration. If the study doctor finds, that the patients disease has significantly improved he/she will enter a treatment free follow-up period of 8 weeks. In total the study consists of 5 to 6 clinical visits (V1 - V6) and 1 telephone follow-up call.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
156
To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis
Time frame: From day 1 of treatment until end of treatment
To determine the optimal dose of IMP in mesalazine-refractory ulcerative colitis
Time frame: After study is completed
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...and 16 more locations