Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis (KARE)
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| ClinicalTrials.gov Identifier: NCT04018027 |
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Recruitment Status :
Completed
First Posted : July 12, 2019
Last Update Posted : April 4, 2022
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Sponsor:
Cara Therapeutics, Inc.
Information provided by (Responsible Party):
Cara Therapeutics, Inc.
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Brief Summary:
This is a multicenter, randomized, double-blind, 4-arm, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with atopic dermatitis (AD) and moderate to severe pruritus.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pruritus Atopic Dermatitis | Drug: difelikefalin 0.25 mg Drug: difelikefalin 0.5 mg Drug: difelikefalin 1.0 mg Drug: Placebo | Phase 2 |
The study will consist of a 30-day Screening period, a 7-day Run-In period, a 12-week Placebo-Controlled Treatment period followed by a 4-week Active Extension period and a Follow Up visit approximately 7 days after the last dose of study drug.
All subjects will sign an informed consent form (ICF) and undergo screening for study eligibility.
Subjects will be randomized to receive either placebo or difelikefalin (CR845) tablets at a dose of 0.25 mg, 0.5 mg, or 1.0 mg, orally BID. Intake of the first dose of study drug will be at Day 1.
Subjects who complete the Placebo-Controlled Treatment period of the study will transition into the Active Extension upon completion of the Week 12 visit assessments. All subjects in the Active Extension will receive difelikefalin (CR845).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 401 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Adult Subjects With Atopic Dermatitis |
| Actual Study Start Date : | June 29, 2019 |
| Actual Primary Completion Date : | April 1, 2021 |
| Actual Study Completion Date : | April 1, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Atopic dermatitis
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Difelikefalin 0.25 mg
Oral difelikefalin 0.25 mg tablet administered twice daily
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Drug: difelikefalin 0.25 mg
Oral difelikefalin 0.25 mg administered twice daily
Other Name: CR845 |
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Active Comparator: Difelikefalin 0.5 mg
Oral difelikefalin 0.5 mg tablet administered twice daily
|
Drug: difelikefalin 0.5 mg
Oral difelikefalin 0.5 mg administered twice daily
Other Name: CR845 |
|
Active Comparator: Difelikefalin 1.0 mg
Oral difelikefalin 1.0 mg tablet administered twice daily
|
Drug: difelikefalin 1.0 mg
Oral difelikefalin 1.0 mg administered twice daily
Other Name: CR845 |
|
Placebo Comparator: Placebo
Oral placebo tablet administered twice daily
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Drug: Placebo
Oral Placebo administered twice daily |
Primary Outcome Measures :
- Change from baseline in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale (I-NRS) score at Week 12. [ Time Frame: Baseline, Week 12 ]
Secondary Outcome Measures :
- Reduction of itch intensity as assessed by the proportion of patients achieving an improvement from baseline ≥4 points with respect to the weekly mean of the daily 24-hour I-NRS score at Week 12 [ Time Frame: Week 12 ]
- Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in 5-D Itch Scale score [ Time Frame: Baseline, Week 12 ]
- Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in total Skindex-10 Scale score [ Time Frame: Baseline, Week 12 ]
- Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in Sleep Quality Assessment. [ Time Frame: Baseline, Week 12 ]
- Percent of subjects with adverse events. [ Time Frame: Baseline, Week 12 ]
Information from the National Library of Medicine
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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:
- Subject has clinically confirmed diagnosis of active AD;
- Subject has at least a 12-month history of AD;
- Subject has chronic itch related to AD;
- Subject has moderate to severe pruritus;
- Female subject is not pregnant or nursing during any period of the study.
Key Exclusion Criteria:
A patient will be excluded from the study if any of the following criteria are met:
- Subject has clinically infected AD;
- Subject has pruritus attributed to a cause other than AD;
- Subject has any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
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): NCT04018027
Locations
Hide 40 study locations
| United States, Alabama | |
| Cara Therapeutics Study Site | |
| Anniston, Alabama, United States, 36207 | |
| Cara Therapeutics Study Site | |
| Birmingham, Alabama, United States, 35209 | |
| United States, Arizona | |
| Cara Therapeutics Study Site | |
| Scottsdale, Arizona, United States, 85254 | |
| United States, Arkansas | |
| Cara Therapeutics Study Site | |
| Bryant, Arkansas, United States, 72022 | |
| United States, California | |
| Cara Therapeutics Study Site | |
| Fountain Valley, California, United States, 92708 | |
| Cara Therapeutics Study Site | |
| Lomita, California, United States, 90717 | |
| United States, Connecticut | |
| Cara Therapeutics Study Site | |
| Cromwell, Connecticut, United States, 06416 | |
| Cara Therapeutics Study Site | |
| Farmington, Connecticut, United States, 06030 | |
| United States, Florida | |
| Cara Therapeutics Study Site | |
| Aventura, Florida, United States, 33180 | |
| Cara Therapeutics Study Site | |
| Miami Lakes, Florida, United States, 33014 | |
| Cara Therapeutics Study Site 2 | |
| Miami, Florida, United States, 33125 | |
| Cara Therapeutics Study Site | |
| Miami, Florida, United States, 33174 | |
| Cara Therapeutics Study Site | |
| Ocala, Florida, United States, 34470 | |
| Cara Therapeutics Study Site | |
| Sarasota, Florida, United States, 34239 | |
| Cara Therapeutics Study Site | |
| Sweetwater, Florida, United States, 33172 | |
| United States, Georgia | |
| Cara Therapeutics Study Site | |
| Columbus, Georgia, United States, 31904 | |
| United States, Idaho | |
| Cara Therapeutics Study Site | |
| Boise, Idaho, United States, 83704 | |
| Cara Therapeutics Study Site 2 | |
| Boise, Idaho, United States, 83713 | |
| United States, Louisiana | |
| Cara Therapeutics Study Site | |
| Baton Rouge, Louisiana, United States, 70809 | |
| Cara Therapeutics Study Site | |
| Metairie, Louisiana, United States, 70006 | |
| Cara Therapeutics Study Site | |
| New Orleans, Louisiana, United States, 70115 | |
| United States, Massachusetts | |
| Cara Therapeutics Study Site | |
| Brighton, Massachusetts, United States, 02135 | |
| United States, Nevada | |
| Cara Therapeutics Study Site 2 | |
| Las Vegas, Nevada, United States, 89119 | |
| United States, New Jersey | |
| Cara Therapeutics Study Site | |
| Berlin, New Jersey, United States, 08009 | |
| United States, New York | |
| Cara Therapeutics Study Site | |
| Horseheads, New York, United States, 14845 | |
| Cara Therapeutics Study Site | |
| New York, New York, United States, 10016 | |
| Cara Therapeutics Study Site | |
| New York, New York, United States, 10023 | |
| United States, Ohio | |
| Cara Therapeutics Study Site | |
| Cleveland, Ohio, United States, 44122 | |
| United States, Oklahoma | |
| Cara Therapeutics Study Site | |
| Oklahoma City, Oklahoma, United States, 73118 | |
| Cara Therapeutics Study Site | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Oregon | |
| Cara Therapeutics Study Site | |
| Medford, Oregon, United States, 97504 | |
| United States, South Dakota | |
| Cara Therapeutics Study Site | |
| Rapid City, South Dakota, United States, 57702 | |
| United States, Texas | |
| Cara Therapeutics Study Site 2 | |
| Austin, Texas, United States, 78745 | |
| Cara Therapeutics Study Site | |
| Austin, Texas, United States, 78759 | |
| Cara Therapeutics Study Site | |
| Cypress, Texas, United States, 77433 | |
| Cara Therapeutics Study Site | |
| Dallas, Texas, United States, 75225 | |
| United States, Utah | |
| Cara Therapeutics Study Site | |
| Salt Lake City, Utah, United States, 84117 | |
| United States, Virginia | |
| Cara Therapeutics Study Site | |
| Richmond, Virginia, United States, 23226 | |
| Canada, Ontario | |
| Cara Therapeutics Study Site | |
| London, Ontario, Canada | |
| Canada, Quebec | |
| Cara Therapeutics Study Site | |
| Montréal, Quebec, Canada | |
Sponsors and Collaborators
Cara Therapeutics, Inc.
Investigators
| Study Director: | Kristine Nograles | Cara Therapeutics |
| Responsible Party: | Cara Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT04018027 |
| Other Study ID Numbers: |
CR845-210501 |
| First Posted: | July 12, 2019 Key Record Dates |
| Last Update Posted: | April 4, 2022 |
| Last Verified: | March 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Cara Therapeutics, Inc.:
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Atopic Dermatitis Pruritus CR845 Chronic Itch difelikefalin |
Itch Itching Generalized pruritus Eczema |
Additional relevant MeSH terms:
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Dermatitis, Atopic Dermatitis Eczema Pruritus Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Skin Manifestations |