Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis
Status:
Recruiting
Trial end date:
2028-11-27
Target enrollment:
Participant gender:
Summary
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
patients with prior TNFi failure or intolerance will be enrolled. Outside of the US, TNFi
naïve and TNFi experienced patients 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 5 mg BID with the
option for individual dose increase to 10 mg BID adult dose equivalent if dose escalation
criteria are met.
The primary objective of this study is to evaluate the efficacy of tofacitinib based on
remission in pediatric participants with moderately to severely active UC. The primary
endpoint is remission by central read Mayo score following 44 weeks in the maintenance phase.
Remission is defined by a Mayo score of 2 points or lower, with no individual subscore
exceeding 1 point and a rectal bleeding subscore of 0.
The study Design is an open-label Phase 3 study that includes a screening period of up to
4-weeks duration, an 8-week or 16-week induction phase, a 44-week maintenance phase, and a
24-month extension phase for pediatric participants with moderately to severely active UC.
Participants will have a follow-up visit 4 weeks after the last dose of study intervention
and a telephone contact 8 weeks later to assess for any adverse events (AEs)/serious adverse
events (SAEs). The total maximum duration of this study will be up to 180 weeks.