Crohn's Disease MedDRA version: 17.1 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856
Conditions
Interventions
Product Name: ABT 494 3mg
Pharmaceutical Form: Capsule
INN or Proposed INN: Not applicable
Current Sponsor code: ABT-494
Other descripti
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male or female = 18 and = 75 years of age at Baseline -Diagnosis of Crohn's disease (CD) for at least 90 days -CDAI = 220 and = 450 -Subject inadequately responded to or experience intolerance to previous treatment with an anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol). 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 168 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 42
Exclusion criteria
Exclusion criteria: -Subject with ulcerative colitis (UC), collagenous colitis or indeterminate colitis -Subject who has had surgical bowel resections in the past 6 months or is planning resection -Subjects with an ostomy or ileoanal pouch -Subject with bowel stricture or abdominal or peri-anal abcess -Subject who has short bowel syndrome -Subject with chronic recurring infections or active Tuberculosis (TB)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this study are to determine the efficacy and safety of multiple doses of ABT-494 versus placebo and to assess the pharmacokinetics (PK) of ABT-494 following oral administration in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to anti-TNF therapy.;Secondary Objective: Not applicable; Primary end point(s): The co-primary endpoints are: -Proportion of subjects who achieve endoscopic remission at Week 12/16. -Proportion of subjects who achieve clinical remission at Week 16. ;Timepoint(s) of evaluation of this end point: week 12/16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of subjects who achieve CDAI < 150 at Week 16. - Proportion of subjects with decrease in CDAI = 70 points from Baseline at Week 16. - Proportion of subject who achieve remission at Week 52. ;Timepoint(s) of evaluation of this end point: Duration of the study. | — |
Countries
Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Romania, Slovakia, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd
Outcome results
None listed