A study to evaluate the efficacy and safety of PF-06480605 in adult participants with moderate to severe ulcerative colitis (TUSCANY 2)

Study Description

This clinical research study is testing the effectiveness and safety of a study drug for treating ulcerative colitis.

• The first part of the study will compare the study drug to a placebo. A placebo looks like the study drug, but it does not contain any active ingredients.
• In the second part of the study, all participants will receive the study drug. 

Description of treatment or intervention (Mechanism of Action)

• The study drug known as anti-TL1A is given as injections under the skin.
• Anti-TL1A has a novel mechanism of action and is known to play a central role in the immune response by blocking inflammation. 

Patient Participation Requirements

• If you join the Tuscany 2 Study, you will be in the study for about 70 weeks.
• For the first 12 weeks you will receive the study drug or placebo, once every 4 weeks.
• For the following 40 weeks, everyone will receive the study drug once every 4 weeks.
• You may also be allowed to continue taking your usual medicines - this will be discussed with you.
• Your part in the study will end 12 weeks after you stop taking the study drug.
• In total, you can expect to visit the study site about 21 times.
• Study visits will include health and well-being checks, such as medical questionnaires, physical examinations, blood, urine and stool samples, tests on your heart (ECGs) and three endoscopies.
• We will also ask you to complete a daily study diary.

These health checks and the study diary help us find out how your ulcerative colitis is responding.

Possible risks and side effects

• There are risks associated with taking any medication and the same applies to the study drug.
• You may experience side effects or find that your ulcerative colitis symptoms do not change or increase in severity.
• It is important that you mention any concerns to your study doctor as they will be able to give you more detailed information.

Progress to date

• A previous phase 2A study, B7541002, conducted in 50 patients with UC was completed and has shown positive results in before and after treatment by centrally read colonoscopy scores: https://clinicaltrials.gov/ct2/show/study/NCT02840721