Who is eligible to participate in the RESPONSE study?
To qualify for this study you must:
- Be 18 to 75 years old (inclusive)
- Have been on a stable and recommended dose of UDCA for the past 12 months or have developed troublesome side effects from UDCA that required you to stop taking the medication
- Be diagnosed with PBC
- Have blood laboratory test results in the following range:
- Alkaline phosphatase (ALP) at least 1.67 times the upper limit of normal (ULN)
- Bilirubin test levels less than two times the ULN
Why should I participate in this study?
A clinical research study, or clinical study, is a planned set of tests conducted over time to learn about a new drug. The RESPONSE study is being conducted in order to learn more about the efficacy and safety of seladelpar, an investigational drug for the potential treatment of PBC.
If you qualify for and participate in this study, you may receive the following:
- Seladelpar (study drug), or placebo, and UDCA (if applicable)
- Study-related care from a physician with significant experience treating people with PBC
- Study-related medical tests
All study medication and study-related care will be at no cost to you.
After participation in this study, you may be eligible to participate in the ASSURE long-term study (CB8025-31731) of seladelpar. Everyone in the long-term study will receive seladelpar at no cost for at least three years or until the development program is cancelled.
It is important to note that participating in this study will help to advance research related to the efficacy and safety of seladelpar. However, seladelpar may not have an effect on your PBC. Obeticholic acid (OCA or OCALIVA®) is an FDA/EMA approved treatment option for you. If you are not currently taking or aware of OCA, you should discuss your treatment options with your doctor.
What happens if I volunteer to participate in RESPONSE?
After you decide to volunteer, the study doctor and staff will provide you with an informed consent document. If you consent to participate in the study, the study staff will give you some tests to make sure you qualify. This is called the “screening period,” and getting all of the results can last approximately 4 weeks.
If you qualify during the screening period and you want to participate, you’ll receive seladelpar (study drug) or placebo to take orally (by mouth) once a day for 52 weeks. After the first 6 months, your dose may change if you are not responding well.
During the study (a total of about 52 weeks), you will have approximately six visits to the study doctor’s office. You may also have a follow-up visit after you leave the study. You will be reimbursed for any study-related travel expenses you incur.