The primary purpose of this multi-centre, double blind-study is to evaluate the clinical response of patients with moderate to severe Cohn's Disease (CD) following treatment with different doses and dose regimens of Olokizumab, relative to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Subjects will receive one of the following treatment regimens as subcutaneous injection solution on Weeks 0, 2, 4, 6, 8, 10, 12 and 14 of the Treatment Period: * OKZ 120 mg every 2 weeks * OKZ 240 mg every 2 weeks * OKZ 120 mg every 2 weeks, with a loading dose of OKZ 480 mg at Week 0 1.6 mL of OKZ drug substance presented in a glass vial with a 1.2 mL extractable volume at a concentration of 100 mg/mL in the formulation buffer, containing 25 mM sodium citrate, 90 mM sodium chloride, 0.02 % (weight/volume) polysorbate 80, pH 6.0.
Subjects will receive Placebo every 2 weeks as a subcutaneous injection solution (0.9% sodium chloride preservative-free for injection) on Weeks 0, 2, 4, 6, 8, 10, 12 and 14 of the Treatment Period.
Percentage of subjects with clinical response or remission as measured by the Crohn's Disease Activity Index (CDAI) at Week 8
Time frame: Week 8
Percentage of subjects with clinical response as measured by the Crohn's Disease Activity Index (CDAI) at Week 16
Time frame: Week 16
Percentage of subjects with clinical remission as measured by the Crohn's Disease Activity Index (CDAI) at Week 16
Time frame: Week 16
Change from Baseline in the Crohn's Disease Activity Index (CDAI) to Week 16
Time frame: From Baseline to Week 16
Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 16
Time frame: From Baseline to Week 16
Percentage of subjects with Inflammatory Bowel Disease Questionnaire (IBDQ) response at Week 16
Time frame: Week 16
Percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 16
Time frame: Week 16
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