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

NCTNCT03995212Other idCR845-210401

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Slow enrollment due primarily to Covid-19

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 14 participants (actual)
Sponsor: Cara Therapeutics, Inc. · Industry
Design: Randomized · Triple masking
Countries: 1 country
United States
Start: 25 Jun 2019
Primary completion: 29 Jun 2022
Completion: 29 Jun 2022
First posted: 21 Jun 2019
Last update posted: 3 Jul 2023
Conditions: Cholestatic Pruritus

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20192020202120222023

Ph 2
Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus
NCT03995212
25 Jun 2019 to 29 Jun 2022
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

CR845 1.0 mgDrug
PlaceboDrug

Arms2

Active comparator
CR845 1.0 mg
Oral CR845 1.0 mg tablet administered twice daily
Placebo comparator
Placebo
Oral placebo tablet administered twice daily

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
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 outcomes(3)

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
Registry description
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.
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
Registry description
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.
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
Registry description
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".

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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