A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib with Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects with Moderately to Severely Active Crohn's Disease and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy - M14-671

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 137 人开始时间: 2024年4月12日最近更新: 2024年8月21日

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•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).

•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.

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