lcerative Colitis: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis
- Conditions
- lcerative ColitisMedDRA version: 20.0Level: PTClassification code: 10009900Term: Colitis ulcerative Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2022-501788-41-00
- Lead Sponsor
- Abbvie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 112
Pediatric male or female subjects 2 to 17 years of age at screening and Baseline visits, Eligible subjects must have moderately to severely active UC, defined as an AMS of 5 to 9 points and endoscopy subscore of 2 or 3 (confirmed by central reader) and an inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy., Subject must have total body weight at time of screening and Baseline of = 10 kg., Documented diagnosis of UC prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy., Subjects must have discontinued: The biologic agents infliximab and adalimumab, including biosimilars, 2 half-lives prior to Baseline. Any other biologic agent or procedure within 30 days or 5 half-lives prior to Baseline, whichever is longer, and no longer be currently enrolled in another interventional clinical study. Note: No minimum washout prior to Baseline is required for any biologic therapy if there is proper documentation of an undetectable drug level measured by a commercially available assay.
Subject have had previous exposure to JAK inhibitors (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib)., Subject have a history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months. Urine drug screen can be performed at screening, per investigator's discretion., Subject have received fecal microbial transplantation within 30 days prior to Baseline., Subject have current or past history of infection., The investigator has reason to believe that the subject is an unsuitable candidate to participate in the study, receive study drug, or would be placed at risk by participating in the study, Subjects have any of the following medical diseases or disorders: a) Disease limited to the rectum (ulcerative proctitis) during the screening endoscopy. b) History of colectomy (total or subtotal), ileoanal pouch, Kock pouch, or ileostomy or planned bowel surgery. c) Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, and aorto-coronary bypass surgery; d) History of an organ transplant which requires continued immunosuppression; e) History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class; f) History of gastrointestinal (GI) perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment, including history of volvulus and/or intussusception (telescoping of bowels); g) Diagnosis of Crohn's Disease or indeterminant colitis; h) Current diagnosis of fulminant colitis and/or toxic megacolon, Principal Exclusion Criteria 6 –(continued) i) Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; subjects with a history of gastric banding/segmentation are not excluded; j) History of malignancy except for successfully treated NMSC or localized carcinoma in situ of the cervix; k) A participant who has had extensive colitis for = 8 years, or disease limited to the left side of the colon for = 12 years, must: a) Have had a full colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study intervention, or b) Have a full colonoscopy with surveillance for dysplasia as the Baseline endoscopy during the screening period. Results from these surveillance biopsies must be negative for dysplasia (low-grade, high-grade, or indeterminant) prior to the first administration of study intervention; l) Primary immune deficiency.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method