Tuscany 2 - A STUDY OF PF-06480605 IN ADULTS WITH ULCERATIVE COLITIS
Research type
Research Study
Full title
A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
IRAS ID
272231
Contact name
Daniel Alvarez
Contact email
Sponsor organisation
Pfizer Inc
Eudract number
2019-002698-74
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 25 days
Research summary
Inflammatory Bowel Disease (IBD) is a chronic inflammatory condition of the gastrointestinal tract that affects 5 million people worldwide. IBD presents as 1 of 2 major forms, ulcerative colitis (UC) or Crohn’s disease (CD). UC is characterised by continuous inflammation localised to the colon (large intestine) and CD is characterised by discontinuous inflammation that affects the entire gastrointestinal tract.
UC is a lifelong condition with a serious effect on quality of life, it can occur at any age, with incidence peaks between 15 to 25 years and 55 to 65 years. In the UK, medications available for UC consist of steroids and anti-TNF inhibitors etc. Despite multiple therapies being available, limitations remain for treatment.
This purpose of this study is to compare the effects of the study drug (anti TL1A/PF 06480605 with a placebo (dummy drug) to find out which is better in treating UC.
This study consists of 4 periods lasting up to 65 weeks; screening (up to 6 weeks), induction, chronic therapy, and follow-up (12 weeks). Participants aged between 18 to 75 years with severe to moderate UC are invited to take part.
Screening will consist of a review of medical history, current/prior medications, and a Colonoscopy/sigmoidoscopy to confirm moderate to severe UC disease. Participants will also have biopsies taken during this procedure so that their tissue can be analysed.
During the 12-week induction period, participants will receive 50 mg, 150 mg, 450 mg, or a placebo. Participants will receive treatment injected under the skin (subcutaneously) once every 4 weeks at their scheduled study visit.
During the 40-week chronic therapy period, all participants will receive active drug: 50 mg, 150 mg, or 450 mg injected under the skin (subcutaneously) every 4 weeks.
It is expected that 3 patients in total in the United Kingdom will participate.REC name
East of Scotland Research Ethics Service REC 2
REC reference
20/ES/0099
Date of REC Opinion
17 Nov 2020
REC opinion
Further Information Favourable Opinion