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A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease

RecruitingPhase 3Ages 2 Years - 17 YearsAllAbbVie
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In plain words

What the trial is, and whether it could suit you

Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to \< 18 years old who have had intolerance or inadequate response to other therapies. Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and CD and is being developed for the treatment of CD in pediatrics. This study is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where pa

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 โ‰ฅ 6 for ileocolonic or colonic disease (or SES-CD of โ‰ฅ 4 for isolated ileal disease) * Demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates (This drug class is not sufficient for eligibility for subjects in France, Italy, Netherlands, Spain, and Sweden), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), IMMs, and/or biologic therapies Exclusion Criteria: * History of hereditary fructose intolerance (a rare genetic condition) or 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: 1. Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD. 2. A diagnosis of CD prior to 2 years of age. 3. A diagnosis or suspected diagnosis of a primary immunodeficiency. 4. 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. 5. Ostomy or ileoanal pouch. 6. Diagnosis of short gut or short bowel syndrome. 7. 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.
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What it tests

  • Risankizumab
  • Risankizumab
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Where

85 sites
Phoenix Children's Hospital /ID# 255766
Phoenix, United States
Arkansas Children's Hospital /ID# 255762
Little Rock, United States
UCSF Benioff Children's Hospital - Oakland /ID# 258327
Oakland, United States
Children's Hospital Colorado - Aurora /ID# 255764
Aurora, United States
Arnold Palmer Hospital for Children Center Digestive Health and Nutrition-Orland /ID# 255437
Orlando, United States
Indiana University Health Riley Hospital for Children /ID# 256454
Indianapolis, United States
Massachusetts General Hospital - Mass General Waltham /ID# 255767
Waltham, United States
MNGI Digestive Health, P. A. /ID# 255366
Minneapolis, United States

โ€ฆand 77 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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