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Trial record 5 of 29 for:    Cara Therapeutics

Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis (KARE)

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: NCT04018027
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Cara Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE July 9, 2019
First Posted Date  ICMJE July 12, 2019
Last Update Posted Date August 12, 2020
Actual Study Start Date  ICMJE June 29, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2019)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2020)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2019)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis
Official Title  ICMJE 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
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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Pruritus
  • Atopic Dermatitis
Intervention  ICMJE
  • Drug: difelikefalin 0.25 mg
    Oral difelikefalin 0.25 mg administered twice daily
    Other Name: CR845
  • Drug: difelikefalin 0.5 mg
    Oral difelikefalin 0.5 mg administered twice daily
    Other Name: CR845
  • Drug: difelikefalin 1.0 mg
    Oral difelikefalin 1.0 mg administered twice daily
    Other Name: CR845
  • Drug: Placebo
    Oral Placebo administered twice daily
Study Arms  ICMJE
  • Active Comparator: Difelikefalin 0.25 mg
    Oral difelikefalin 0.25 mg tablet administered twice daily
    Intervention: Drug: difelikefalin 0.25 mg
  • Active Comparator: Difelikefalin 0.5 mg
    Oral difelikefalin 0.5 mg tablet administered twice daily
    Intervention: Drug: difelikefalin 0.5 mg
  • Active Comparator: Difelikefalin 1.0 mg
    Oral difelikefalin 1.0 mg tablet administered twice daily
    Intervention: Drug: difelikefalin 1.0 mg
  • Placebo Comparator: Placebo
    Oral placebo tablet administered twice daily
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 10, 2020)
410
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2019)
240
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Georgine Ragsdale 203-406-3700 clinicaltrials.gov@caratherapeutics.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04018027
Other Study ID Numbers  ICMJE CR845-210501
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cara Therapeutics, Inc.
Study Sponsor  ICMJE Cara Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kristine Nograles Cara Therapeutics
PRS Account Cara Therapeutics, Inc.
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP