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Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis · Sponsor: Pfizer
About this study
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 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 a…
This description comes directly from the study's public registry record.
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No contact information is available for this study as per the public registry record.
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Locations (69)
| Children's Hospital Los Angeles | Los Angeles, California, United States | — |
| University of California, San Francisco Benioff Children's Hospital | San Francisco, California, United States | — |
| University of California, San Francisco Pediatric Clinical Research Center (PCRC) | San Francisco, California, United States | — |
| Connecticut Children's Ambulatory Surgical Center | Farmington, Connecticut, United States | — |
| Connecticut Children's Infusion Center | Farmington, Connecticut, United States | — |
| Connecticut Children's Medical Center | Hartford, Connecticut, United States | — |
| Nicklaus Children's Hospital | Miami, Florida, United States | — |
| Center for Advanced Pediatrics | Atlanta, Georgia, United States | — |
| Children's Healthcare of Atlanta - Arthur M. Blank Hospital | Atlanta, Georgia, United States | — |
| Boston Children's Hospital | Boston, Massachusetts, United States | — |
| Northwell Health - Cohen Children's Medical Center | Lake Success, New York, United States | — |
| Northwell Health - Cohen Children's Medical Center | New Hyde Park, New York, United States | — |
+ 57 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04624230