[M16-194] A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab with Open-Label Induction, Randomized Double-Blind Maintenance, and Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) with Moderately to Severely Active Crohn's Disease

AbbVie G.K.0 个研究点目标入组 110 人开始时间: 2025年3月21日最近更新: 2025年4月10日

适应症

试验速览

暂无简介。

•Pediatric individuals, 2 to < 18 years old
•Must have moderately to severely active CD, as defined by the PCDAI score > 30 assessed at Baseline
•Must have endoscopic evidence of mucosal inflammation as documented by the SES-CD of >= 6 for ileocolonic or colonic disease (or SES-CD of >= 4 for isolated ileal disease)
•Demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates, oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), IMMs, and/or biologic therapies

•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
•Any of the following medical disorders:
•a. Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD.
•b. A diagnosis of CD prior to 2 years of age.
•c. A diagnosis or suspected diagnosis of a primary immunodeficiency.
•d. Currently known complications of CD such as:
•Active abscess (abdominal or perianal);
•Symptomatic bowel strictures;
•> 2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon,
•and rectum;
•Fulminant colitis;
•Toxic megacolon;
•Or any other manifestation that might require surgery while enrolled in the study.
•e. Ostomy or ileoanal pouch.
•f. Diagnosis of short gut or short bowel syndrome.
•g. Surgical bowel resection within the past 3 months prior to Baseline (excluding gastrointestinal surgeries which are not bowel resections such as appendectomy or ostomy closure), or a history of >3 bowel resections.

发起方

AbbVie G.K.