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Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995212
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Cara Therapeutics, Inc.

Study Description
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Brief Summary:
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of twice-daily (BID) oral CR845 1.0 mg in patients with PBC with moderate-to-severe pruritus. The study includes a 16-week Treatment Period.

Condition or disease Intervention/treatment Phase
Cholestatic Pruritus Drug: CR845 1.0 mg Drug: Placebo Phase 2

Detailed Description:

This study will consist of a Screening Visit, a 7-day Run-in Period, a 16-week Treatment Period, and a Follow-up Visit (approximately 7-10 days after the last dose of study drug). Informed consent will be obtained prior to performing any study-specific procedures.

The Screening Visit will occur within 7 to 28 days prior to randomization to assess eligibility.

Day 1 of the Treatment Period will be defined as the day of the administration of the first dose of study drug. If patients continue to meet all inclusion and no exclusion criteria at the end of the 7-day Run-in Period, they will be randomized in a 1:1 ratio to receive either placebo or CR845 tablets at a dose of 1.0 mg orally BID for 16 weeks.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CR845 1.0 mg
Oral CR845 1.0 mg tablet administered twice daily
 Drug: CR845 1.0 mg
Oral CR845 1.0 mg administered twice daily
Other Names:
  • CR845
  • Difelikefalin
Placebo Comparator: Placebo
Oral placebo tablet administered twice daily
 Drug: Placebo
Oral Placebo administered twice daily


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline to Week 16 with respect to the weekly mean of the daily 24-hour Worst Itching Intensity Numeric Rating Scale (WI-NRS) score. [ Time Frame: Baseline, Week 16 ]
    Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable".


Secondary Outcome Measures :
  1. Improvement in itch-related quality of life as assessed by the change from baseline to Week 16 in total Skindex-10 Scale score [ Time Frame: Baseline, Week 16 ]
    The Skindex-10 Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past week. The questions cover 3 domains: disease, mood/emotional distress, and social functioning domain. A lower total score represents better quality of life.

  2. Improvement in itch-related quality of life as assessed by the change from baseline to Week 16 in 5-D Itch Scale score [ Time Frame: Baseline, Week 16 ]
    The 5-D Itch Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past 2 weeks. The questions cover five dimensions of itch including the degree, duration of itch/day, direction (improvement/worsening), disability (impact on activities such as work), and body distribution of itch. A lower total score represents better quality of life.

  3. Reduction of itch intensity as assessed by the proportion of patients achieving an improvement from baseline ≥3 points with respect to the weekly mean of the daily 24-hour WI-NRS score at Week 16 [ Time Frame: Week 16 ]
    Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable".


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

To be eligible for inclusion into the study, a patient must meet the following criteria:

  • Confirmed diagnosis of PBC;
  • If currently taking ursodeoxycholic acid (UDCA), should be on stable dose for >12 weeks prior to screening and plan on continuing to take UDCA throughout the study;
  • If previously taking UDCA, should have discontinued its use >12 weeks prior to screening;
  • Self-reports experiencing daily or near-daily pruritus during the month prior to screening;
  • Prior to randomization has a mean baseline WI-NRS score indicative of moderate to severe pruritus.

Key Exclusion Criteria:

A patient will be excluded from the study if any of the following criteria are met:

  • Presence of Child-Pugh Class C decompensated cirrhosis at screening;
  • Itching secondary to biliary obstruction;
  • History or presence of hepatocellular carcinoma, hepatic abscess, or acute portal vein thrombosis;
  • Current placement on liver transplantation list with anticipated liver transplant during the course of the study or current Model for End-stage Liver Disease (MELD) score ≥15;
  • Alanine aminotransferase or aspartate aminotransferase >5 × upper limit of normal at screening, or within 2 months prior to screening;
  • Anticipates receiving an opioid antagonist (eg, naloxone, naltrexone) or opioid-mixed agonist-antagonist (eg, buprenorphine, nalbuphine) from the start of screening through the end of the Treatment Period;
  • New or change of treatment with antihistamines and corticosteroids (oral, intravenous, or topical), opioids, gabapentin, pregabalin, cholestyramine, rifampicin or fibrates within 14 days prior to screening.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995212


Contacts
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Contact: Georgine Ragsdale, PharmD 203-406-3700 clinicaltrials.gov@caratherapeutics.com

Locations
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United States, California
Cara Therapeutics Study Site Recruiting
Coronado, California, United States, 92118
Cara Therapeutics Study Site Recruiting
Rialto, California, United States, 92377
Cara Therapeutics Study Site Recruiting
San Clemente, California, United States, 92673
Cara Therapeutics Study Site Recruiting
San Francisco, California, United States, 94109
United States, Florida
Cara Therapeutics Study Site Recruiting
Miami, Florida, United States, 33136
Cara Therapeutics Study Site Recruiting
Plantation, Florida, United States, 33322
United States, Indiana
Cara Therapeutics Study Site Recruiting
Indianapolis, Indiana, United States, 46202
United States, Maryland
Cara Therapeutics Study Site Recruiting
Baltimore, Maryland, United States, 21202
United States, Massachusetts
Cara Therapeutics Study Site Recruiting
Burlington, Massachusetts, United States, 01805
United States, Michigan
Cara Therapeutics Study Site Recruiting
Novi, Michigan, United States, 48377
United States, Pennsylvania
Cara Therapeutics Study Site Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Cara Therapeutics Study Site Recruiting
Providence, Rhode Island, United States, 02905
United States, Tennessee
Cara Therapeutics Study Site Recruiting
Nashville, Tennessee, United States, 37212
United States, Texas
Cara Therapeutics Study Site Recruiting
Arlington, Texas, United States, 76012
Cara Therapeutics Study Site Recruiting
Edinburg, Texas, United States, 78539
Cara Therapeutics Study Site Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cara Therapeutics, Inc.
Investigators
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Study Director: Frédérique Menzaghi, PhD Cara Therapeutics
More Information
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Responsible Party: Cara Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03995212    
Other Study ID Numbers: CR845-210401
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cara Therapeutics, Inc.:
Primary Biliary Cholangitis
Pruritus
CR845
Chronic Itch
 difelikefalin
Itch
Itching
Generalized pruritus
Additional relevant MeSH terms:
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Cholangitis
Pruritus
Skin Diseases
Skin Manifestations
 Signs and Symptoms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases