A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies
- Conditions
- Crohn's Disease (CD)MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2017-001240-35-GB
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 501
- Confirmed diagnosis of CD for at least 3 months prior to Baseline.
- Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.
- Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.
- Demonstrated an inadequate response or intolerance to conventional therapies and/or biologic therapies, in the opinion of the investigator, as defined below:
Oral locally acting steroids
Intravenous or oral corticosteroids
Immunosuppressants
Biologic therapies for CD
Note: Non-bio-IR subjects who have received prior biologic for up to 1 year but have not failed may be enrolled; however, participants must
have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled
disease),
- 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 476
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
Subject with a current diagnosis of ulcerative colitis or indeterminate colitis.
- Subject not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX).
- Subject with the following known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, > 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum, symptomatic bowel strictures, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
- Subject with ostomy or ileoanal pouch
- Subject diagnosed with short gut or short bowel syndrome
- Screening laboratory and other analyses show abnormal results.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).;Secondary Objective: To evaluate improvements in several efficacy parameters, including steroid discontinuation, laboratory parameters and quality of life questionnaires.;Primary end point(s): Co-primary Endpoints: <br>1. Proportion of subjects with clinical remission per PROs at Week 12, and<br>2. Proportion of subjects with endoscopic response at Week 12.;Timepoint(s) of evaluation of this end point: Week 12
- Secondary Outcome Measures
Name Time Method