CymaBay – Seladelpar RESPONSE Phase 3 study now enrolling
For more information see clinicaltrials.gov The following summary is provided by CymaBay Therapeutics.
RESPONSE (study number CB8025-32048) is a Phase 3 clinical research study being conducted to learn more about the effectiveness and safety of seladelpar, a new investigational drug for the potential treatment of patients with primary biliary cholangitis (PBC).
Data from previous studies in patients with PBC provide preliminary evidence of seladelpar’s potential to treat PBC. These data have demonstrated that seladelpar may improve PBC-related blood laboratory tests and symptoms of PBC, thus suggesting that it may benefit PBC patients.
The RESPONSE study is enrolling patients who have been using ursodeoxycholic acid (UDCA or ursodiol) but have not achieved the recommended treatment goal or who develop troublesome side effects from UDCA that prevent them from continuing to take this treatment. In this study, we want to find out if seladelpar can improve PBC-related blood laboratory tests and can improve symptoms of PBC, such as itching.
The RESPONSE study will also ask patients who enter the study to consider a biopsy at baseline and end of treatment. The biopsy is voluntary and performed only if it is considered safe by the study doctor. Participating in this aspect of the research study is vitally important to help researchers and regulators better understand the changes in your liver health and the effect that seladelpar has on your liver health.
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:
o Alkaline phosphatase (ALP) at least 1.67 times the upper limit of normal (ULN)
o Bilirubin test levels less than two times the ULN
Doctors will check other requirements to confirm that you qualify for this study.
If you are currently taking UDCA, you will continue to take your UDCA at the same and recommended dose during study participation. During the study, you will be reimbursed for your UDCA for 12 months (the duration you are in the study). You will also begin to take seladelpar (study drug) or placebo, orally (by mouth) once a day for 52 weeks. At the end of the study, you may be given the opportunity to participate and receive seladelpar in the open label ASSURE long-term study (CB8025-31731-RE).
There is no guarantee at this point in time, that being treated with seladelpar will have any effect on your PBC. There is also a 1 in 3 chance you will receive placebo in this study. Placebo is an inactive substance that looks like the investigational drug (seladelpar). During the study, neither you nor your doctor will know if you are receiving placebo or seladelpar.