Recruiting
Phase 3

Upadacitinib

Sponsor:

AbbVie

Code:

NCT06332534

Conditions

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Interventions

Upadacitinib

Study Details

Brief summary:

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.

Conditions

Crohn's Disease

Study ID

NCT06332534

Start date

Aug 8, 2024

Status verified date

Jun, 2026

Completion date

Dec, 2034

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Period 1: Open Label Induction Phase (Dose A)

All participants in the open label induction phase of Period 1 will receive upadacitinib Dose A for 12 weeks based on body weight.

experimental: Period 1: Double-Blind Maintenance Phase (Dose B)

Clinical responders per PCDAI at the end of open label induction phase of Period 1 will be randomly assigned to receive Dose B or C for 52 weeks (oral solution dose will be based on body weight)

experimental: Period 1: Double-Blind Maintenance Phase (Dose C)

Clinical responders per PCDAI at the end of open label induction phase of Period 1 will be randomly assigned to receive either upadacitinib Dose C or B for 52 weeks (oral solution dose will be based on body weight)

experimental: Period 2: Open Label Long-Term Extension Phase Cohort 1

Participants receiving double-blind maintenance therapy with upadacitinib Dose B or upadacitinib Dose C daily in Period 1 who complete the Week 64 visit will receive upadacitinib Dose B daily for up to 156 weeks.

experimental: Period 2: Open Label Long-Term Extension Phase Cohort 2

Participants who were receiving rescue therapy with open-label upadacitinib Dose C during maintenance phase in Period 1 and completed the Week 64 visit will continue to receive upadacitinib Dose C daily for up to 156 weeks.

experimental: Period 2: Open Label Long-Term Extension Phase Cohort 3

Participants who did not achieve clinical response per PCDAI at Week 12 of Period 1 will receive an extended treatment with open-label upadacitinib Dose C daily for an additional 12 weeks. If they are responders after 12 weeks extended treatment, they will continue, otherwise they may be discontinued at the discretion of the investigator

Interventions

Upadacitinib

Oral Solution/ Extended-Release Tablets

Primary outcome measure

  • 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 [ Time Frame: At Week 64 ]
  • Achievement of endoscopic response at Week 64 in participants who achieved clinical response per PCDAI at Week 12. [ Time Frame: At Week 64 ]
  • Number of Participants with Adverse Events [ Time Frame: Through Week 156 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

UCSF Benioff Children's Hospital - Oakland /ID# 262217

Recruiting

Oakland, California, United States, 94609

Lucile Packard Children's Hospital /ID# 262193

Recruiting

Palo Alto, California, United States, 94304

Children's Hospital Colorado - Aurora /ID# 262207

Recruiting

Aurora, Colorado, United States, 80045

Connecticut Children's Medical Center - Hartford /ID# 262256

Recruiting

Hartford, Connecticut, United States, 06106

OSF St. Francis Medical Center /ID# 262192

Recruiting

Peoria, Illinois, United States, 61637-0001

Indiana University Health Riley Hospital for Children /ID# 262215

Recruiting

Indianapolis, Indiana, United States, 46202

Boston Children's Hospital /ID# 262191

Recruiting

Boston, Massachusetts, United States, 02115

MNGI Digestive Health, P. A. /ID# 262204

Recruiting

Minneapolis, Minnesota, United States, 55413-2195

Icahn School of Medicine at Mount Sinai /ID# 262216

Recruiting

New York, New York, United States, 10029

Univ NC Chapel Hill /ID# 262198

Recruiting

Chapel Hill, North Carolina, United States, 27514-4220

UH Cleveland Medical Center /ID# 262188

Recruiting

Cleveland, Ohio, United States, 44106

Children's Hospital of Philadelphia - Main /ID# 262197

Recruiting

Philadelphia, Pennsylvania, United States, 19104-4319

BC Children's Hospital /ID# 262237

Recruiting

Vancouver, British Columbia, Canada, V6H 3V4

IWK Health Center /ID# 262543

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

CHU Sainte-Justine /ID# 262096

Recruiting

Montreal, Quebec, Canada, H3T 1C5

More Information

Sponsor

AbbVie

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Keywords

  • Crohn's Disease
  • Upadacitinib
  • RINVOQ

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AbbVie on 2026-06-24.