Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects with Moderately to Severely Active Crohn's Disease

Phase 1

Conditions: Crohn's Disease (CD)
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: CTIS2023-509618-12-00

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 137

Inclusion Criteria

Weight at Screening and Baseline must be = 10 kg, Moderate to severe CD defined as PCDAI > 30 and endoscopic evidence of mucosal inflammation as documented by a centrally read SES-CD of >/ 6 (or SES-CD of >/4 for isolated ileal disease) excluding the presence of narrowing component., Documented diagnosis of CD prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of CD, in the assessment of the investigator, must be available, Demonstrated an inadequate response, loss of response, or intolerance to corticosteroids, IMMs, and/or biologic therapy or in whom use of those therapies is medically contraindicated. For participants in the US, participants must have demonstrated an inadequate response, loss or response, or intolerance to one or more anti-TNFs (tumor necrosis factor).

Exclusion Criteria

History of: A diagnosis of CD prior to 2 years of age., Currently known complications of CD such as: Active abscess (abdominal or perianal);, Currently known complications of CD such as: Symptomatic bowel strictures, Currently known complications of CD such as: More than 2 missing segments of the following 5 intestinal segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum, Currently known complications of CD such as: Surgical bowel resection within the past 3 months prior to Baseline, or a history of more than 3 bowel resections., History of Fulminant colitis or toxic megacolon, History of Gastrointestinal 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), Current diagnosis of any primary immune deficiency, 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.