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
- Upadacitinib (drug)
- How long the study runs
- Study runs about 124 months (dates as stated)
- About the drug or intervention
- Upadacitinib — drug: Oral Solution/ Extended-Release Tablets
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by AbbVie, is looking at how well a medicine called upadacitinib works, how safe it is, and how it moves through the body, in children with moderately to severely active Crohn's disease (a condition causing inflammation in the gut).
Who can take part
- Children weighing at least 10 kg
- Moderate to severe Crohn's disease, shown by a high activity score and gut inflammation seen on a camera test (endoscopy)
- Crohn's disease diagnosed before the study starts and confirmed by a colonoscopy during screening
- Existing treatments (such as steroids, immunomodulators, or biologic medicines) have not worked well, have stopped working, caused bad side effects, or cannot be used for medical reasons (in the US and South Korea, this must include having tried at least one anti-TNF medicine)
Who may not be able to
- Crohn's disease diagnosed before the age of 2
- Certain complications of Crohn's disease, such as an active abscess in the tummy or around the back passage, symptoms caused by narrowed sections of bowel, or having an ostomy or ileoanal pouch
- More than 2 missing sections out of 5 parts of the bowel, bowel surgery in the past 3 months, or more than 3 bowel removal operations in the past
- For people in Japan only: a positive or two unclear results on a test for a fungal infection called Pneumocystis jiroveci
- A current diagnosis of ulcerative colitis, indeterminate colitis, or a rare inherited form of inflammatory bowel disease
- Past severe bowel conditions, such as fulminant colitis, toxic megacolon, a hole in the bowel, diverticulitis, or a high risk of a hole in the bowel
- A current diagnosis of a problem with the immune system from birth (primary immune deficiency)
- Conditions that could stop the medicine being absorbed properly, such as short bowel syndrome or gastric bypass surgery (gastric banding is allowed)
What taking part involves
- • Taking the study medicine upadacitinib — details of doses or how it is taken: Not stated — ask the trial team
- • Other tests or treatments involved: Not stated — ask the trial team
Time commitment: Number of visits, how long the study lasts, and what taking part involves: Not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 2 Years to 17 Years
- Who
- All
- Number of participants
- 110
- Started
- 2024-08-08
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for crohn's disease
- • Phase3 - 110 participants
- • Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels
Who can take part?
- • Ages 2 Years to 17 Years
- • Diagnosed with crohn's disease
Where?
- • Cambridge - Addenbrookes Hospital /ID# 262707
- • Sheffield - Sheffield Children's Hospital NHS Foundation Trust /ID# 261832
- • London - Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 262811
- • Norwich - Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 262778
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective oral Upadacitinib is in treating moderately to severely active Crohn's Disease in pediatric participants aged 2 to 18 years old who have had inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy. Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 52-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given (UPA Dose B or Dose C). Period 2 is a 156-week open-label extension of Period 1. Approximately 110 pediatric participants with moderate to severely active CD will be enrolled at approximately 92 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will have a safety follow up for 30 days after discontinuation from any time point within the study. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) 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
What the study is looking for
- ✓Weight at Screening and Baseline must be \>= 10 kg
Who cannot take part
- ✗History of:
- ✗A diagnosis of CD prior to 2 years of age.
- ✗Currently known complications of CD such as:
- ✗Active abscess (abdominal or perianal);
- ✗causing symptoms bowel strictures;
See the full criteria
Where Is This Study? (5 UK sites)
Addenbrookes Hospital /ID# 262707
Cambridge CB2 2QQ, United Kingdom
Sheffield Children's Hospital NHS Foundation Trust /ID# 261832
Sheffield S10 2TH, United Kingdom
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 262811
London E1 2ES, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 262778
Norwich NR4 7UY, United Kingdom
Royal Hospital for Children and Young People /ID# 262388
Edinburgh EH16 4TJ, United Kingdom
How to Get in Touch
ABBVIE CALL CENTER
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