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Evaluating Upadacitinib for treating Crohn's Disease in children

A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib With Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects With Moderately to Severely Active Crohn's Disease and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy

Phase 3 Interventional AbbVie · NCT06332534

This study is testing if Upadacitinib can help children aged 2 to 18 with moderate to severe Crohn's Disease feel better when other treatments haven't worked for them.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment110 (estimated)
Ages2 Years to 17 Years
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionsUpadacitinib
Locations84 sites (Oakland, California and 83 other locations)
Trial IDNCT06332534 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of Upadacitinib, an oral medication, in pediatric patients aged 2 to 18 years with moderately to severely active Crohn's Disease. The study includes a 12-week open-label induction phase where participants will receive the medication to assess its impact on their condition. Eligible participants must have previously shown inadequate response or intolerance to other treatments such as corticosteroids or biologics. The trial aims to provide insights into how well Upadacitinib can manage symptoms and improve the quality of life for young patients suffering from this chronic condition.

Who should consider this trial

Good fit: Ideal candidates are children aged 2 to 18 years with a documented diagnosis of moderately to severely active Crohn's Disease who have not responded to or cannot tolerate standard treatments.

Not a fit: Patients who have not been diagnosed with Crohn's Disease or those who have not experienced inadequate response to previous therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of Crohn's Disease in pediatric patients, offering a new option for those who have not responded to existing therapies.

How similar studies have performed: Previous studies have shown promising results with Upadacitinib in adult populations, indicating potential for success in pediatric applications.

Eligibility criteria

Show full inclusion / exclusion 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 this trial is running

Oakland, California and 83 other locations

+34 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn's DiseaseUpadacitinibRINVOQ
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.