B7981005_Ph2b_Compare PF-06651600/PF-06700841/PBO in mod/sev UC
Research type
Research Study
Full title
A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND CHRONIC THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
IRAS ID
217176
Contact name
Rajiv Chandy
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2016-003708-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 3 days
Research summary
The purpose of this study is to compare the effects of the study drugs, PF-06651600 and PF-06700841, with placebo to find out which drug is better for treating Ulcerative Colitis.
Ulcerative Colitis is a lifelong condition which has a serious effect on the quality of life that the patient has. Despite multiple therapies being available for this condition, limitations remain in the treatment of Ulcerative Colitis, and patients continue to have symptoms or develop intolerance to or side effects from their treatment regimens. Because of the significantly reduced risk for immunogenicity and the potential for oral administration, small molecule inhibitors have emerged as an attractive therapeutic option. This study will include a JAK3-specific inhibitor and a TYK2/JAK1-specific inhibitor, each arm will address a biologically distinct question. Each study drug will be broken down by the body using slightly different signalling pathways and from this it will be determined which one is more effective at reducing inflammation.
Male or female patients between the ages of 18 and 70 are eligible for this study. This is a global study and will be conducted in 22 countries in approximately 180 research sites. It is expected that there will be approximately 8 sites in the UK and approximately 40 patients will be recruited in the UK. The study is expected to last around 35 months, the patient will be participating for 42 weeks and will have to visit the site around 11 times during this period.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0207
Date of REC Opinion
8 Sep 2017
REC opinion
Further Information Unfavourable Opinion