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A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Oral CR845 in Patients with Primary Biliary Cholangitis (PBC) and Moderate-To-Severe Pruritus

Clinical Trial Details

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:
   

  • Group A: 1.0 mg tablet twice daily of CR845 for 16 weeks
  • Group B: 1.0 mg tablet twice daily of placebo for 16 weeks
       

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.

 

Key Eligibility: 
  • Men and women who are 18-80 years of age
  • Have been diagnosed with PBC and have moderate-to-severe pruritus (itching) due to PBC

Detailed eligibility reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Mallory Ianelli, RN, BSN
(646) 962-4040
mai2016@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1907020489

ClinicalTrials.gov:

NCT03995212

Sponsor:

CR845-210401

Status

Open to Enrollment

Age Group

Adult

Sponsor