Last updated 5 days ago
Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
110 patients around the world
Available in Puerto Rico, Brazil, United States
AbbVie
3Research sites
110Patients around the world
This study is for people with
Crohn's disease
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- 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 of response, or intolerance to one or more anti-TNFs.
- History of:A diagnosis of CD prior to 2 years of age.Currently known complications of CD such as:Active abscess (abdominal or perianal);Symptomatic bowel strictures;More than 2 missing segments of the following 5 intestinal segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum;Ostomy or ileoanal pouch;Surgical bowel resection within the past 3 months prior to Baseline, or a history of more than 3 bowel resections.Japan participants only: positive result of beta-D-glucan or two consecutive indeterminate results of beta-D-glucan during the Screening period (screening for Pneumocystis jiroveci infection)History of any of the following:Current diagnosis of UC, indeterminate colitis, or monogenic IBD;Fulminant colitis or toxic megacolon;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 deficiencyConditions 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.
Sites
Hospital Pequeno Príncipe
Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Recruiting
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
Recruiting
StudyU-EMPOWER
SponsorAbbVie
Study typeInterventional
Conditions
Crohn's disease
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06332534
