Study to Evaluate the Safety of CR845 in Patients with PBC and Moderate-To-Severe Pruritus

• Research type

  Research Study

• Full title

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

• IRAS ID

  1003325

• Contact name

  Frederique Menzaghi

• Sponsor organisation

  Cara Therapeutics, Inc.

• Eudract number

  2019-004842-14

• Research summary

  Patients with liver disease, including Primary Biliary Cholangitis (PBC) commonly experience itchy skin (pruritus). Although pruritus varies in severity it is often long-term (chronic). This usually causes reduced quality of life. Current treatments for pruritus either have several side effects, no benefit or risks of causing liver damage (hepatoxicity). The purpose of this study is to see if the investigational (not approved for sale) CR845 oral tablets (taken by mouth) can reduce the intensity of participants itching and whether it is well tolerated (accepted) by their body. The effectiveness of CR845 will be compared against a placebo (study drug that contains no medicinal ingredients).

  CR845 is a kappa-opioid receptor (KOR), a chemical structure found in the central nervous system (CNS) which responds to itch and pain signals. There are 3 subtypes of opioid receptors: mu, kappa and delta. CR845 was designed to activate KORs in the nervous system outside the brain and spinal cord and body’s defence cells, which are known to control itch, pain, and inflammatory (swelling) signals, without producing the side effects associated with activation of mu-opioid receptors, found in current treatments. Additionally, as CR845 does not activate other receptors, and does not enter the CNS, it is expected to be safer and better tolerated.
  CR845 given intravenously (into a vein) was shown to reduce pruritus in haemodialysis patients in two studies. Giving CR845 after each haemodialysis (3 times a week) significantly reduced the severity of itch intensity and improved patient’s itch-related quality of life in these studies. Based on these results, it is expected that CR845 will produce a combined anti-itch and anti-inflammatory effect which could provide significant relief of itch in patients with PBC.

  This study will include approximately 60-80 participants, at around 25 study hospitals in the United States and 5 in the United Kingdom.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  21/SC/0345

• Date of REC Opinion

  2 Dec 2021

• REC opinion

  Further Information Favourable Opinion