At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Risankizumab (drug), Risankizumab (drug)
- How long the study runs
- Study runs about 64 months (dates as stated)
- About the drug or intervention
- Risankizumab — drug: Intravenous (IV) Infusion · Risankizumab — drug: Subcutaneous (SC) Injection
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 2 Years to 17 Years
- Who
- All
- Number of participants
- 110
- Started
- 2023-12-11
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for crohn's disease
- • Phase3 - 110 participants
- • Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever
Who can take part?
- • Ages 2 Years to 17 Years
- • Diagnosed with crohn's disease
Where?
- • Sheffield - Sheffield Children's Hospital NHS Foundation Trust /ID# 255758
- • London - Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 255757
- • Birmingham - Birmingham Women's and Children's NHS Foundation Trust /ID# 255759
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 2 Years - 17 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ moderately to severely active CD, as defined by the PCDAI score \> 30 assessed at Baseline
What the study is looking for
- ✓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...
Who cannot take part
- ✗Any of the following medical disorders:
- ✗Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD.
- ✗A diagnosis of CD prior to 2 years of age.
- ✗A diagnosis or suspected diagnosis of a primary immunodeficiency.
- ✗Currently known complications of CD such as:
See the full criteria
Where Is This Study? (3 UK sites)
Sheffield Children's Hospital NHS Foundation Trust /ID# 255758
Sheffield S10 2TH, United Kingdom
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 255757
London E1 2ES, United Kingdom
Birmingham Women's and Children's NHS Foundation Trust /ID# 255759
Birmingham B4 6NH, United Kingdom
How to Get in Touch
ABBVIE CALL CENTER
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