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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002517-11 | EudraCT Number |
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Study was withdrawn due to delay in timelines. There were no safety concerns regarding the study or the compound in the decision to withdraw the trial.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OKZ 120 mg | Experimental |
| |
| OKZ 240 mg | Experimental |
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| OKZ 120 mg with 480 mg loading dose at Week 0 | Experimental |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olokizumab (OKZ) | Drug | 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with clinical response or remission as measured by the Crohn's Disease Activity Index (CDAI) at Week 8 | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with clinical response as measured by the Crohn's Disease Activity Index (CDAI) at Week 16 | Week 16 | |
| Percentage of subjects with clinical remission as measured by the Crohn's Disease Activity Index (CDAI) at Week 16 | Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000592400 | olokizumab |
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| Placebo | Drug | 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. |
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| Change from Baseline in the Crohn's Disease Activity Index (CDAI) to Week 16 | From Baseline to Week 16 |
| Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 16 | From Baseline to Week 16 |
| Percentage of subjects with Inflammatory Bowel Disease Questionnaire (IBDQ) response at Week 16 | Week 16 |
| Percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 16 | Week 16 |
| D007410 | Intestinal Diseases |