Ulcerative Colitis
Conditions
Interventions
Product Name: Risankizumab
Product Code: ABBV-006
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: RISANKIZUMAB
Current S
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Entry and completion of Study M16-067 or Study M16-065. Completion includes the final endoscopy of Study M16-067 or Study M16-065. Achieved clinical response at the last visit of Study M16-067 or Study M16-065. Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 700 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study. Subject who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of CHO, or had an AE during Study M16-067 or Study M16-065 that in the Investigator's judgment makes the subject unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study M16-066 comprises three sub-studies: Sub-study 1: Randomized, double-blind, placebo-controlled maintenance To evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active ulcerative colitis (UC) who responded to IV risankizumab induction treatment in Study M16-067 or Study M16-065. Sub-study 2: Randomized, exploratory maintenance To evaluate the efficacy and safety of two different dosing regimens for risankizumab (therapeutic drug monitoring vs clinical assessment for dose escalation) as maintenance therapy in subjects with moderately to severely active UC who responded to induction treatment in Study M16-067 or Study M16-065. Sub-study 3: Open-label long term extension To evaluate long-term safety of risankizumab in subjects who completed Sub-study 1 or 2. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab. ;Secondary Objective: ; Primary end point(s): Sub-study 1 or 2 : Proportion of subjects with clinical remission per Adapted Mayo score at Week 52. Sub-study 3: Evaluation of long-term safety ;Timepoint(s) of evaluation of this end point: Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of subjects with endoscopic improvement at Week 52. 2. Proportion of subjects achieving clinical remission per Full Mayo score at Week 52. 3. Proportion of subjects with steroid-free remission at Week 52. 4. Proportion of subjects with sustained clinical remission per Adapted Mayo score at Week 52. 5. Proportion of subjects who discontinued corticosteroid use at Week 52. 6. Proportion of subjects with sustained endoscopic improvement at Week 52. 7. Proportion of subjects with clinical response per Adapted Mayo score at Week 52. 8. Proportion of subjects with endoscopic remission at Week 52. 9. Proportion of subjects with hospitalizations through Week 52. 10. Change from Baseline in UC-Symptom Questionnaire (UCSQ) at Week 52. 11. Proportion of subjects with histologic remission at Week 52. 12. Proportion of subjects with mucosal healing at Week 52. 13. Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 52. 14. Proportion of subjects with UC-related surgeries through Week 52. 15. Change from Baseline in Short Form-36 at Week 52. 16. Change from Baseline in FACIT-Fatigue at Week 52. ;Timepoint(s) of evaluation of this end point: Week 52 | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd
Outcome results
None listed