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Looking for participantsPhase3

Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease

Sponsor: AbbVie

NCT ID: NCT06332534

View on ClinicalTrials.gov ↗

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.

Crohn's Disease

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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  • • 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
Inclusion Criteria: * Weight at Screening and Baseline must be \>= 10 kg * Moderate to severe Crohn's Disease (CD) defined as Pediatric Crohn's Disease Activity Index (PCDAI) \> 30 and endoscopic evidence of mucosal inflammation as documented by a centrally read SES-CD of \>= 6 (or SES-CD of \>=4 for isolated ileal disease) excluding the presence of narrowing component. * Documented diagnosis of CD prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of CD, in the assessment of the investigator, must be available * Demonstrated an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators (IMMs), and/or biologic therapy or in whom use of those therapies is medically contraindicated. For participants in the US and South Korea, participants must have demonstrated an inadequate response, loss of response, or intolerance to one or more anti-TNFs (tumor necrosis factor). Exclusion Criteria: * History of: * A diagnosis of CD prior to 2 years of age. * Currently known complications of CD such as: * Active abscess (abdominal or perianal); * Symptomatic bowel strictures; * More than 2 missing segments of the following 5 intestinal segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum; * Ostomy or ileoanal pouch; * Surgical bowel resection within the past 3 months prior to Baseline, or a history of more than 3 bowel resections. * Japan participants only: positive result of beta-D-glucan or two consecutive indeterminate results of beta-D-glucan during the Screening period (screening for Pneumocystis jiroveci infection) * History of any of the following: * Current diagnosis of ulcerative colitis (UC), indeterminate colitis, or monogenic inflammatory bowel disease (IBD); * Fulminant colitis or toxic megacolon; * Gastrointestinal (GI) perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment including history of volvulus and/or intussusception (telescoping of bowels); * Current diagnosis of any primary immune deficiency * Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; subjects with a history of gastric banding/segmentation are not excluded.

Where Is This Study? (5 UK sites)

Addenbrookes Hospital /ID# 262707

Cambridge CB2 2QQ, United Kingdom

Recruiting

Sheffield Children's Hospital NHS Foundation Trust /ID# 261832

Sheffield S10 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 262811

London E1 2ES, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 262778

Norwich NR4 7UY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Julie Dawson

rdsubmissions@nnuh.nhs.uk01603 286611

Royal Hospital for Children and Young People /ID# 262388

Edinburgh EH16 4TJ, United Kingdom

Recruiting

How to Get in Touch

ABBVIE CALL CENTER

Sponsor contact

CONTACT

844-663-3742 abbvieclinicaltrials@abbvie.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-06