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

Launched by ABBVIE · Mar 25, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a medication called Upadacitinib (also known as RINVOQ) to see how safe and effective it is for treating children and teenagers aged 2 to 18 years with moderately to severely active Crohn's disease. Crohn's disease is a long-term condition that causes inflammation in the digestive tract, leading to symptoms like stomach pain, diarrhea, and weight loss. The study is open to participants who haven’t found relief from other treatments, such as steroids or biologic therapies, or who cannot use those treatments for medical reasons.

If eligible, participants will take Upadacitinib daily for a period of time and will attend regular check-ups to monitor their health and any side effects. The study has two main parts: an initial 12-week phase where everyone knows they are receiving the treatment, followed by a longer phase where neither the participants nor the doctors will know which specific dose they are receiving. Overall, the trial will involve about 110 participants across 92 locations worldwide. It’s important to note that participants may face more visits and procedures than usual and will be monitored closely during the study.

Gender

ALL

Eligibility criteria

• 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);
• • 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 UC, indeterminate colitis, or monogenic IBD;
• • Fulminant colitis or toxic megacolon;
• • 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.