Risankizumab 10 mg/ml (DrugBank: Risankizumab)
1 diseaseID | Disease name (Link within this page) | Number of trials |
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96 | Crohn disease | 1 |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
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1 | EUCTR2013-002902-29-DE (EUCTR) | 22/12/2014 | 08/08/2014 | Efficacy, safety and pharmacokinetics of BI 655066/ABBV-066 (risankizumab) in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066/ABBV-066 (risankizumab), an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: Risankizumab 10 mg/ml INN or Proposed INN: Risankizumab Product Code: Risankizumab 90 mg/ml INN or Proposed INN: Risankizumab | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of |