ClinicaliQ Trial Snapshot
- Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis — Active Not Recruiting • Phase III • Gastroenterology • NCT04624230.
- Tofacitinib tablet oral treatment for children aged 2-17 with moderate-severe ulcerative colitis, measuring remission rates after 44 weeks.
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What This Trial Is Studying
This study, A3921210 is designed to evaluate the efficacy, safety and pharmacokinetics (PK) of tofacitinib in pediatric participants with moderately to severely active UC. In the US and EU, patients with prior TNFi failure or intolerance will be enrolled. Outside of the US or EU, patients having had inadequate response or intolerance to oral or IV corticosteroids or azathioprine or 6-mercaptopurine or TNFi will be enrolled. All eligible participants will initially receive open label tofacitinib at a dose expected to produce equivalent systemic exposure to that observed in adults receiving…