Pizzicato is a clinical research study designed to assess two different investigational medications compared to placebo drug for people diagnosed with moderate to severe Crohn’s Disease.
The study will compare the effects of two different medications, PF-06651600 and PF-06700841, compared to a placebo (inactive medicine). It is normal practice to measure results against a placebo in research studies in order to definitively analyse outcomes as a result of the investigational drugs.
PF-06651600 and PF-06700841 are both oral medications, designed to be taken once a day.
Half the participants enrolled in the study will be randomly assigned to the PF-06651600 dosing arm, and half the participants will be randomly assigned to the PF-06700841 dosing arm. Should you participate, you will only be assigned to one of these groups. You and your study doctor will know which group you are assigned, but you and your study doctor will not know if you are receiving placebo or active drug. You cannot choose which dosing group you are assigned.
If you agree to take part, your involvement in the study would last for around 74 weeks. There are four distinct phases to the study – screening, induction dosing, extension dosing and follow-up.
Screening can take up to 6 weeks during which time you would be assessed to see if the study is right for you. If you were eligible to join, you would receive one of the investigational medicines (or placebo) for a total of 12 weeks (induction dosing), then for the extension dosing phase, you would receive one of the investigational medicines (no placebo) for a total of 52 weeks, followed by a 4-week follow-up period. After enrolment, you will know which dosing arm (PF-06651600 or PF-06700841) you are assigned.
If you are eligible to join, the investigational medicine will be randomly assigned (by chance, like the flip of a coin) to patients at the beginning of the dosing phase. You will have a 1 in 3 chance of receiving placebo and a 2 in 3 chance of receiving active medicine in the dosing phase. This dosing period lasts for 12 weeks. At the Week 12 visit, everyone will move into the extension dosing phase, which lasts for 52 weeks. In this phase, you will receive the active medicine (no placebo drug) from the dosing arm you had previously been assigned (possibly at a different dosage). After 52 weeks of dosing, there is a 4-week follow-up period.
You would need to make at least 15 visits to a study center and some of these visits could take several hours.
Your health and wellbeing would be monitored throughout the study. This would involve various health assessments such as medical questionnaires, blood, urine and stool samples and physical examinations including endoscopy (where a flexible tube with a camera is used to examine your colon).