Crohn's disease - inflammatory bowel disease
Conditions
Interventions
Patients will receive 2 sub cutaneous injections at every study visit, which
will occur every 8 weeks, until end of trial visit. One syringe contains 90
mg/ml of Risankizumab.
Sponsors
AbbVie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with Crohn`s disease, who have successfully completed the preceding trial 1311.6. Successful treatment is defined as: - Completion of period 2 in 1311.6 with a clinical response (drop in CDAI from baseline by but no remission (CDAI =100) or remission (CDAI
Exclusion criteria
Exclusion criteria: 1. Patients who were not compliant with key study procedures (colonoscopy, treatment compliance, endpoint assessment, contraception measures) in preceding trial 1311.6 2. Patients who could not tolerate BI 655066 treatment for tolerability or safety reasons in the preceding trial 3. Are pregnant, nursing, or planning pregnancy while enrolled in the study, or within 20 weeks after receiving the last dose of study medication. 4. Patients must agree not to receive a live virus or bacterial or BCG vaccination during the study or up to 12 months after the last administration of study drug. 5. Patients who have developed malignancy, or suspicion of active malignant disease during the preceding trial 6. Are intending to participate in any other study using an investigational agent or procedure during participation in this study. 7. Cannot adhere to the concomitant medication requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective of this study is to evaluate long term safety of Risankizumab in patients who have achieved clinical response or remission after use of Risankizumab. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives is to further investigate long-term efficacy, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of Risankizumab. | — |
Countries
Netherlands
Outcome results
None listed