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RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
2 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 140 days
  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be followed-up for approximately 140 days."
  • "The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe risankizumab is, how well it works, and how it moves through the body. It is for children ages 2 to under 18 with moderate to severe Crohn’s disease whose other treatments did not help enough or caused problems. The drug is given into a vein and later as shots under the skin.

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 participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based induction regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Approximately 110 pediatric participants with CD will be enrolled at around 100 sites worldwide. Participants in SS1 will receive risankizumab intravenously during the 12-week induction period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously during the 208-week open label period. Participants will be followed-up for approximately 140 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Must be age 2 to under 18.
  • Must have moderate to severe active Crohn’s disease, with a disease activity score called PCDAI above 30 at the start.
  • A camera exam of the bowel must show swelling and irritation. The SES-CD score must be at least 6, or at least 4 if only the last part of the small bowel is affected.
  • At least one past treatment must have failed to help enough or caused problems: aminosalicylates, steroids, immune-system medicines, or biologic medicines. Aminosalicylates alone do not qualify in France, Italy, the Netherlands, Spain, or Sweden.

Who can't join

  • An inherited condition that prevents the body from breaking down fructose, a type of sugar, or an allergy or strong sensitivity to the study drug’s ingredients or similar drugs.
  • Ulcerative colitis, bowel inflammation of an unclear type, or inflammatory bowel disease caused by a change in a single gene.
  • Crohn’s disease diagnosed before age 2.
  • A known or suspected condition in which the immune system does not work properly.
  • Certain Crohn’s complications: pockets of infection in the belly or near the anus, narrowed bowel causing symptoms, more than 2 of 5 specified bowel sections missing, very severe colon inflammation, dangerous swelling of the colon, or another problem that may need surgery during the study.
  • An ostomy (a surgically made opening for waste) or an ileoanal pouch (a pouch made from the small bowel and joined to the anus).
  • Short bowel syndrome, a condition caused by not having enough small bowel.
  • Surgery to remove part of the bowel within 3 months before the study starts, or more than 3 such surgeries in the past. Other surgeries, such as appendix removal or ostomy closure, do not count.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 ≥ 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 (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.

Study sites (11)

AR

AZ

CA

CO

FL

  • Arnold Palmer Hospital for Children Center Digestive Health and Nutrition-Orland /ID# 255437 · Orlando, FL 32806-1141More trials in Orlando

IN

MA

MN

NJ

NY

OH