Cholestatic Pruritus Clinical Trial
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
| Verified date | June 2023 |
| Source | Cara Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 14 |
| Est. completion date | June 29, 2022 |
| Est. primary completion date | June 29, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Cara Therapeutics Study Site | Arlington | Texas |
| United States | Cara Therapeutics Study Site | Boston | Massachusetts |
| United States | Cara Therapeutics Study Site 2 | Boston | Massachusetts |
| United States | Cara Therapeutics Study Site | Colorado Springs | Colorado |
| United States | Cara Therapeutics Study Site | Coronado | California |
| United States | Cara Therapeutics Study Site | Indianapolis | Indiana |
| United States | Cara Therapeutics Study Site | Miami | Florida |
| United States | Cara Therapeutics Study Site | Morgantown | West Virginia |
| United States | Cara Therapeutics Study Site | Nashville | Tennessee |
| United States | Cara Therapeutics Study Site | New York | New York |
| United States | Cara Therapeutics Study Site | Newport News | Virginia |
| United States | Cara Therapeutics Study Site | Plantation | Florida |
| United States | Cara Therapeutics Study Site | Rialto | California |
| United States | Cara Therapeutics Study Site | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Cara Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | 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". | Baseline, Week 16 | |
| Secondary | Improvement in itch-related quality of life as assessed by the change from baseline to Week 16 in total Skindex-10 Scale score | 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. | Baseline, Week 16 | |
| Secondary | Improvement in itch-related quality of life as assessed by the change from baseline to Week 16 in 5-D Itch Scale score | 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. | Baseline, Week 16 | |
| Secondary | 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 | 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". | Week 16 |