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NCT04624230 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis
A Phase 3 study of Ulcerative Colitis, sponsored by Pfizer.
- Active
- Registry status
- Phase 3
- Development phase
- 118
- Enrollment target
- 20
- Study locations
NCT04624230 is a Phase 3 study of Ulcerative Colitis that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 118 participants, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT04624230, a Phase 3 study of Ulcerative Colitis, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 118 participants
- Enrollment target
- 20
- Study locations
Study 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 (AEs)/serious adverse events (SAEs). The total maximum duration of this study will be up to 180 weeks.
Conditions Studied
Interventions
- DRUG tofacitinib
Study Locations (20)
California
- Children's Hospital Los Angeles - Los Angeles
- University of California, San Francisco Benioff Children's Hospital - San Francisco
- University of California, San Francisco Pediatric Clinical Research Center (PCRC) - San Francisco
Connecticut
- Connecticut Children's Ambulatory Surgical Center - Farmington
- Connecticut Children's Infusion Center - Farmington
- Connecticut Children's Medical Center - Hartford
New Jersey
- Atlantic Children's Health-Pediatric Gastroenterology & Nutrition - Morristown
- Goryeb Children's Hospital (Endoscopy only) - Morristown
- Atlantic Health System- Morristown Medical Center (Pharmacy) - Morristown
Pennsylvania
- Buerger Center for Advanced Pediatric Care - Philadelphia
- Children's Hospital of Philadelphia - Philadelphia
- Roberts Center for Pediatric Research - Philadelphia
Georgia
- Center for Advanced Pediatrics - Atlanta
- Children's Healthcare of Atlanta - Arthur M. Blank Hospital - Atlanta
New York
- Northwell Health - Cohen Children's Medical Center - Lake Success
- Northwell Health - Cohen Children's Medical Center - New Hyde Park
Florida
- Nicklaus Children's Hospital - Miami
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2021-08-12 |
| Est. Completion | 2029-07-18 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04624230
The ClinicalTrials.gov registry entry for NCT04624230 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (94% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which tofacitinib is the first listed.
NCT04624230 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Connecticut, New Jersey.
Frequently Asked Questions
What is clinical trial NCT04624230 about?
NCT04624230 is a clinical study titled "Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis". 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...
What is the current status of trial NCT04624230?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 118 participants. The study started on 2021-08-12. Estimated completion is 2029-07-18.
What conditions does trial NCT04624230 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT04624230?
The interventions under investigation include: tofacitinib (DRUG).
Who is sponsoring clinical trial NCT04624230?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04624230 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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