Phase 3 Crohn's Disease and Colitis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Children and teenagers between 2 and 17 years old
- People with moderately to severely active Crohn's disease, based on a specific scoring system called the PCDAI (a score above 30 at the start of the trial)
- People whose Crohn's disease shows signs of inflammation in the gut lining, confirmed by a camera examination (endoscopy), with results meeting specific score thresholds depending on which part of the bowel is affected (confirm with trial site)
- People who have either had a bad reaction to, or not responded well enough to, at least one of the following types of treatment: aminosalicylates (note: this type alone is not enough to qualify in France, Italy, Netherlands, Spain, or Sweden), steroid tablets that work locally in the gut, systemic steroids such as prednisone, immune-suppressing medicines, or biologic therapies
Who may not be able to join:
- People with a hereditary condition called fructose intolerance, or those who have had an allergic or serious reaction to the study drug or similar medications
- People currently diagnosed with ulcerative colitis, indeterminate colitis, or a genetic form of inflammatory bowel disease
- People who were diagnosed with Crohn's disease before the age of 2
- People who have been diagnosed with, or are suspected of having, a primary immune system disorder
- People currently experiencing certain Crohn's disease complications, such as an active abscess, bowel blockages causing symptoms, a severely inflamed colon (fulminant colitis or toxic megacolon), or other complications that may require surgery during the trial (confirm with trial site)
- People who are missing more than 2 out of 5 specific sections of the bowel (confirm with trial site)
- People who have a stoma (ostomy) or an ileoanal pouch
- People diagnosed with short gut or short bowel syndrome
- People who have had bowel removal surgery in the 3 months before the start of the trial, or who have had more than 3 bowel removal surgeries in total (note: some other gut surgeries such as appendix removal do not count)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: ABBVIE INC., AbbVie
Phone: 844-663-3742
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Cohort 3 (Substudy 2): Percentage of Participants Achieving Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission; Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD); Cohorts 1 & 2: Maximum Observed Serum Concentration (Cmax) of Risankizumab; Cohorts 1 & 2: Time to Cmax (Tmax) of Risankizumab; Cohorts 1 & 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Risankizumab
Can't join this trial?
Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.