2023-509618-12-00RecruitingPhase 3
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
AbbVie Deutschland GmbH & Co. KG25 sites in 7 countries39 target enrollmentStarted: August 5, 2024Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 39
- Locations
- 25
- Primary Endpoint
- Achievement of clinical remission per the Pediatric Crohn's Disease Activity Index (PCDAI) in the participants who achieved clinical response per PCDAI at Week 12
Study Overview
Brief Summary
To demonstrate efficacy of upadacitinib based on a higher rate of participants who achieve the co-primary endpoints of clinical remission per Pediatric Crohn's Disease Activity Index (PCDAI) and endoscopic response at Week 64 in pediatric participants based on the modified intent-to-treat population (consisting of all participants who achieved clinical response per PCDAI at Week 12 and were randomized into the maintenance phase) of at least the upadacitinib 30 mg adult equivalent dose when compared to external placebo
Eligibility Criteria
- Ages
- 0 years to 17 years (0-17 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Weight at Screening and Baseline must be ≥ 10 kg
- •Moderate to severe CD defined as 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, IMMs, and/or biologic therapy or in whom use of those therapies is medically contraindicated. For participants in the US, participants must have demonstrated an inadequate response, loss or 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);
- •Currently known complications of CD such as: Symptomatic bowel strictures
- •Currently known complications of CD such as: More than 2 missing segments of the following 5 intestinal segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum
- •Currently known complications of CD such as: Surgical bowel resection within the past 3 months prior to Baseline, or a history of more than 3 bowel resections.
- •History of Fulminant colitis or toxic megacolon
- •History of Gastrointestinal 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.
Outcomes
Primary Outcomes
Achievement of clinical remission per the Pediatric Crohn's Disease Activity Index (PCDAI) in the participants who achieved clinical response per PCDAI at Week 12
Achievement of clinical remission per the Pediatric Crohn's Disease Activity Index (PCDAI) in the participants who achieved clinical response per PCDAI at Week 12
Achievement of endoscopic response in participants who achieved clinical response per PCDAI at Week 12.
Achievement of endoscopic response in participants who achieved clinical response per PCDAI at Week 12.
Number of Participants with Adverse Events
Number of Participants with Adverse Events
Secondary Outcomes
- Achievement of clinical remission per PCDAI at week 12
- Achievement of endoscopic response at week 12
- Achievement of endoscopic remission at week 12
- Achievement of clinical response per PCDAI at week 12
- Achievement of clinical response per PCDAI at week 64 in participants who achieved clinical response per PCDAI at Week 12
- Achievement of endoscopic remission at Week 64 in participants who achieved clinical response per PCDAI at Week 12
- Achievement of corticosteroid (CS)-free clinical remission per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12
Investigators
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
Study Sites (25)
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