About the Vibrato Research Study
WHAT IS THE AIM OF THE STUDY?
The Vibrato study is a clinical research study designed to compare the effects of two different investigational medications, PF-06651600 and PF-06700841, for people with UC.
WHAT MEDICINE WILL BE INVESTIGATED?
The study will compare the effects of two different medications, PF-06651600 and PF-06700841 alongside 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.
המחקר ישווה את ההשפעות של שתי תרופות שונות, PF-06651600 ו- PF-06700841 להשפעות של פלצבו (תרופה לא פעילה). נהוג במחקרים קליניים להשוות את התוצאות כנגד פלצבו על מנת לנתח באופן מובהק את התוצאות הנובעות מהתרופות הניסיוניות.
PF-06651600 and PF-06700841 are both oral medications.
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.
WHAT WILL HAPPEN DURING THE STUDY?
If you agree to take part, your involvement in the study would last for around 42 weeks. There are four distinct phases to the study – screening, induction, chronic therapy 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 are eligible to join, you would receive one of the investigational medicines (or placebo) for the induction phase of the study. During the chronic therapy phase of the study you will receive the investigational medicine. There is no placebo in the chronic therapy phase of the study. Upon completion of the chronic phase you will enter the 4-week follow-up period, where no investigational medicine is provided.
You would need to make at least 11 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).