Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04624230
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2020-10-26
Brief Title:
Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690550 TOFACITINIB IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 and a telephone contact 8 weeks later to assess for any adverse events AEsserious adverse events SAEs The total maximum duration of this study will be up to 180 weeks
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 AEsserious adverse events SAEs The total maximum duration of this study will be up to 180 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OVATION | OTHER | Alias Study Number | None |
| 2018-002378-30 | EUDRACT_NUMBER | None | None |