This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of the study drug CR845 in subjects with Primary Biliary Cholangitis (PBC) and Moderate-To-Severe Pruritus.
PBC is a chronic disease of the liver resulting from progressive destruction of bile ducts in the liver. Bile is a substance produced by the liver to facilitate digestion. With PBC, the bile ducts develop inflammation and causes liver damage which may eventually lead to cirrhosis (liver scarring). In the early stages of PBC, people may experience itching. CR845 is being developed to reduce the itchiness due to PBC.
The purpose of this study is to see if the investigational/experimental drug CR845 can reduce the intensity of itching due to PBC or whether it is well tolerated.
An investigational/experimental drug is one that is currently being tested and has not been approved by the Food and Drug Administration (FDA) for sale in the United States or by any regulatory authorities in any country in the world. Experimental drugs such as CR845 may be tested in research studies such as this one.
If an individual agrees to participate and meets all the requirements, individuals will be randomized (chosen by chance) to one of the following study groups:
The placebo tablet will look like CR845 but will not contain active medicine/ingredients.
CR845 and placebo will be supplied by Cara Therapeutics which is the sponsor of this study.
Participation in this study will last about 21 weeks. Participants will be compensated for their time.
Detailed eligibility reviewed when you contact the study team.