About the IM011-127 Study
The IM011-127 study is for people diagnosed with moderate to severe UC. The purpose of this study is to test the safety, efficacy (how well it works), and biomarker effect of the study drug BMS-986165. A biomarker is a molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition.
This study includes a double-blind study treatment period and an open-label extension period. Double-blind means neither you nor the study doctor will know which study drug you are receiving. During the double-blind period of the study, 1 dose of BMS-986165 will be compared to placebo. A placebo is an inactive substance that looks like the study drug but has no medical effect. During the open-label period of the study, all participants will receive treatment with BMS-986165. The study drug BMS-986165 and the placebo will be taken by mouth in this study.
To be eligible, patients must:
- Be between 18-65 years of age
- Have moderate to severe UC
- Have tried 1 or more standard-of-care treatments that did not work, stopped working, or were not tolerated.
The study doctor will also check other eligibility requirements.
Study Conduct and Design
The IM011-127 study will include approximately 50 adults. This study will include 4 periods: screening period, double-blind study treatment period, open-label extension period, and follow-up period.
- Screening Period: The screening period may require you to visit the study site for procedures over a period of up to 4 weeks. During this time, study staff will assess your disease status and confirm you can move on to the double-blind study treatment period.
- Double-Blind Study Treatment Period: You will be randomly assigned to 1 of 2 study treatment groups (to receive 1 dose of BMS-986165 or placebo). 75% of participants will be on BMS-986165.
- Open-Label Extension Period: After the double-blind study treatment period, all eligible participants will continue in the open-label extension period where they will receive BMS-986165.
- Follow-up Period: After you stop receiving the study drug, your health will continue to be monitored through follow-up visits.
How can I get involved?
If you meet the listed eligibility criteria and would like to learn more about the IM011-127 study, we would love to hear from you! To speak with the clinical research coordinator, please call (318) 525-3233.