A study to evaluate the efficacy and safety of PF-06480605 in adult participants with moderate to severe ulcerative colitis (TUSCANY 2)
- To evaluate the efficacy of PF-06480605 in induction of clinical remission at Week 14 in participants with moderate to severe active UC.
- To evaluate the safety and tolerability of PF-06480605 during the chronic therapy period (from Week 14 to the End of Study Visit) in participants with moderate to severe active UC during the chronic therapy period.
The study may be an option for you if:
- you are aged between 18 and 75 years
- you have been diagnosed with moderate to severe ulcerative colitis for at least 3 months
- your medication is not relieving your ulcerative colitis symptoms
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