Crohns Disease MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: Risankizumab
Product Code: ABBV-066
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: RISANKIZUMAB
CAS Number: ABBV-066
Concentration unit: mg/ml milligram(s)/millilitre
C
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female aged = 18 to = 80 years of age at the Baseline visit. Confirmed diagnosis of Crohns disease (CD) for at least 3 months prior to Baseline. Crohn's disease activity index (CDAI) score 220 – 450 at Baseline. Confirmed diagnosis of moderate to severe Crohns Disease as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD (SES-CD). Demonstrated intolerance or inadequate response to one or more anti-TNF therapies If female, subject must meet the contraception recommendations Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 483 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: Subject with a current diagnosis of ulcerative colitis or indeterminate colitis. Subjects with unstable doses of concomitant CD therapy Receipt of CD approved biologic agents prior to baseline (as detailed in protocol), or any investigational biologic or other agent or procedure prior to Baseline (as detailed in protocol) Subject with prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab). Subject with complications of CD (strictures, short bowel, etc)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1: The objective is to compare the efficacy and safety of risankizumab versus ustekinumab over 48 weeks for the treatment of adult subjects with moderate to severe Crohn's Disease (CD) who have failed anti-TNF therapy. Part 2: The objective is to evaluate the long-term safety of risankizumab up to 220 weeks in subjects who received risankizumab during Part 1 and have completed the Week 48 visit.;Secondary Objective: NA;Primary end point(s): Part 1: 1. Clinical remission (non-inferiority) at week 24: CDAI < 150 2 . Endoscopic remission (superiority) at week 48: defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) = 4 and at least a 2-point reduction versus Baseline and no sub score greater than 1 in any individual variable, as scored by a central reviewer. Part 2: 1. Evaluation of long-term safety ;Timepoint(s) of evaluation of this end point: Part 1: 1. Week 24 2. Week 48 Part 2: 1. Week 220 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Achievement of clinical remission (CDA < 150) at Week 48: superiority of risankizumab vs. ustekinumab. 2. Achievement of endoscopic response at Week 48, superiority of risankizumab vs. ustekinumab 3. Achievement of endoscopic response at Week 24, superiority of risankizumab vs. ustekinumab 4. Achievement of steroid-free remission Week 48, superiority of risankizumab vs. ustekinumab 5. Achievement of steroid-free clinical remission at Week 48, superiority of risankizumab vs. ustekinumab. ;Timepoint(s) of evaluation of this end point: 1. Week 48 2. Week 48 3. Week 24 4. Week 48 5. Week 48 | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactEu Clinical Trials Helpdesk
AbbVie Ltd
Outcome results
None listed