A3921210_Open-Label study of Tofacitinib in children with UC
Research type
Research Study
Full title
OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
IRAS ID
1003640
Contact name
Chinyu Su
Contact email
Sponsor organisation
Pfizer Inc, 235 East 42nd Street, New York, New York, 10017
Eudract number
2018-002378-30
Research summary
This study is an open label study for patients aged between 2 and 17 yrs old with moderate to severe Ulcerative Colitis (UC), therefore everyone will know what dosage of medication each patient will receive. UC is a chronic, long-term condition where the colon and rectum become inflamed. The colon is the large intestine (bowel) and the rectum is the end of the large intestine. UC can develop at any age but most commonly diagnosed in people aged 15 to 25 years. This affects both men and women.
The purpose of this study is to learn about the effectiveness, safety and interactions in the body of tofacitinib in children with moderate to severe UC. The study drug (tofacitinib) is an investigational drug because it is not approved for use in paediatric UC patients in this country.
Tofacitinib is also known by the trade name Xeljanz and is approved for the treatment of moderately to severely active UC in adults in a total of 73 countries or regions as of 02 September 2020. Tofacitinib also known as CP-690,550 is a type of drug called a Janus kinase (JAK) inhibitor. JAKs are enzymes that are involved in activating the body's immune response, which causes the gut inflammation in UC. Tofacitinib may block this process, and so may reduce the inflammation.
Eligible patients will receive tofacitinib 5 mg twice daily or 10 mg twice daily during all 3 phases of the study: induction, maintenance and extension. If the patient responds to tofacitinib in induction after 8 or 16 weeks of treatment, they will be eligible to enter the maintenance phase of the study. After they complete 44 weeks in the maintenance phase, they will enter the extension phase of the study, which will last another 2 years.
There will be approximately 120 participants in this study across approx 90 different sites in 17 countries. The study will last up to 3.5 years. Various blood tests, physiological tests, diary entries and questionnaires will be asked of the participant throughout the trial.REC name
London - Hampstead Research Ethics Committee
REC reference
21/LO/0690
Date of REC Opinion
25 Nov 2021
REC opinion
Further Information Favourable Opinion