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Upadacitinib for Pediatric Crohn's Disease

This study is looking at Upadacitinib (RINVOQ), a medication already approved for adults, to see how safe and effective it is for children and teenagers (ages 2 to 17) with moderately to severely active Crohn's disease. Crohn's disease is a long-lasting condition that causes inflammation (redness and swelling) in the digestive tract, leading to symptoms like stomach pain and diarrhea. You might be able to join if you have Crohn's disease that hasn't responded well to other treatments. The study will measure how many participants show improvement in their symptoms and healing of their intestines over time. The study plans to enroll about 110 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive Upadacitinib. The study aims to enroll 110 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events (side effects) through Week 156.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06332534

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

Recruiting
PHASE3Ages 2–17InterventionalTreatment
AbbVie
~110 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:Upadacitinib

At a glance

Recruiting sites
81 of 85 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants who achieved clinical response per the Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12, with clinical remission per the PCDAI at Week 64
Measured over At Week 64
+2 more outcomes measured

Conditions

Crohn's Disease

Explore related trials

Crohn Disease

Where it's being run

85 sites across 67 states
Belgium3
Tokyo3
Puerto Rico3
Seoul Teugbyeolsi3
Spain3
California2
New South Wales2
Bulgaria2

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Percentage of participants who achieved clinical response per the Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12, with clinical remission per the PCDAI at Week 64At Week 64

    PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.

  • Achievement of endoscopic response at Week 64 in participants who achieved clinical response per PCDAI at Week 12.At Week 64

    Endoscopic response is defined as \> 50% reduction in Simple Endoscopic Score for Crohn's Disease (SES-CD) score from Baseline (or for participants with a Baseline SES-CD of 4, at least a 2-point reduction from Baseline), as scored by a central reader.

  • Number of Participants with Adverse EventsThrough Week 156

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.