Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)
A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Adult Subjects With Notalgia Paresthetica
1 other identifier
interventional
126
2 countries
36
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with notalgia paresthetica and moderate to severe pruritus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2021
Shorter than P25 for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2021
CompletedStudy Start
First participant enrolled
January 11, 2021
CompletedFirst Posted
Study publicly available on registry
January 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedMay 22, 2023
May 1, 2023
1.3 years
January 11, 2021
May 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the weekly mean of the daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 8.
Baseline, Week 8
Secondary Outcomes (2)
Improvement in itch-related quality of life as assessed by the change from baseline to Week 8 in total Skindex-10 Scale score
Baseline, Week 8
Change from baseline in itch-related Sleep Disturbance Subscale measured by the Itch Medical Outcomes Study (MOS) at Week 8
Baseline, Week 8
Study Arms (2)
Difelikefalin 2.0 mg
ACTIVE COMPARATOROral difelikefalin 2.0 mg tablet administered twice daily
Placebo
PLACEBO COMPARATOROral placebo tablet administered twice daily
Interventions
Oral difelikefalin 2.0 mg administered twice daily
Eligibility Criteria
You may qualify if:
- Subject has clinically confirmed diagnosis of active Notalgia Paresthetica;
- Subject has a history of chronic pruritus due to Notalgia Paresthetica;
- Subject has moderate to severe pruritus;
- Female subject is not pregnant or nursing during any period of the study.
You may not qualify if:
- A patient will be excluded from the study if any of the following criteria are met:
- Subject has pruritus attributed to a cause other than Notalgia Paresthetica;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Cara Therapeutics Study Site
Fort Smith, Arkansas, 72916, United States
Cara Therapeutics Study Site
Hot Springs, Arkansas, 71913, United States
Cara Therapeutics Study Site
Rogers, Arkansas, 72758, United States
Cara Therapeutics Study Site
Fountain Valley, California, 92708, United States
Cara Therapeutics Study Site
Los Angeles, California, 90033, United States
Cara Therapeutics Study Site
San Diego, California, 92122, United States
Cara Therapeutics Study Site
Santa Monica, California, 90404, United States
Cara Therapeutics Study Site
Cromwell, Connecticut, 06416, United States
Cara Therapeutics Study Site
Coral Gables, Florida, 33134, United States
Cara Therapeutics Study Site
Margate, Florida, 33063, United States
Cara Therapeutics Study Site
Miami, Florida, 33144, United States
Cara Therapeutics Study Site
North Miami Beach, Florida, 33162, United States
Cara Therapeutics Study Site
Sandy Springs, Georgia, 30328, United States
Cara Therapeutics Study Site
Indianapolis, Indiana, 46250, United States
Cara Therapeutics Study Site
Plainfield, Indiana, 46168, United States
Cara Therapeutics Study Site
Metairie, Louisiana, 70006, United States
Cara Therapeutics Study Site
New York, New York, 10029, United States
Cara Therapeutics Study Site
High Point, North Carolina, 27262, United States
Cara Therapeutics Study Site
Columbus, Ohio, 43215, United States
Cara Therapeutics Study Site
Charleston, South Carolina, 29407, United States
Cara Therapeutics Study Site
Bellaire, Texas, 77401, United States
Cara Therapeutics Study Site
Pflugerville, Texas, 78660, United States
Cara Therapeutics Study Site
San Antonio, Texas, 78213, United States
Cara Therapeutics Study Site
Salt Lake City, Utah, 84117, United States
Cara Therapeutics Study Site
Norfolk, Virginia, 23502, United States
Cara Therapeutics Study Site
Spokane, Washington, 99202, United States
Cara Therapeutics Study Site
Surrey, British Columbia, Canada
Cara Therapeutics Study Site
Winnipeg, Manitoba, Canada
Cara Therapeutics Study Site
Markham, Ontario, Canada
Cara Therapeutics Study Site
Peterborough, Ontario, Canada
Cara Therapeutics Study Site
Montreal, Quebec, Canada
Cara Therapeutics Study Site
Markham, Canada
Cara Therapeutics Study Site
Montreal, Canada
Cara Therapeutics Study Site
Peterborough, Canada
Cara Therapeutics Study Site
Surrey, Canada
Cara Therapeutics Study Site
Winnipeg, Canada
Related Publications (1)
Kim BS, Bissonnette R, Nograles K, Munera C, Shah N, Jebara A, Cirulli J, Goncalves J, Lebwohl M; KOMFORT Trial Investigators. Phase 2 Trial of Difelikefalin in Notalgia Paresthetica. N Engl J Med. 2023 Feb 9;388(6):511-517. doi: 10.1056/NEJMoa2210699.
PMID: 36780675DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nilam Shah
Cara Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2021
First Posted
January 13, 2021
Study Start
January 11, 2021
Primary Completion
May 18, 2022
Study Completion
June 30, 2022
Last Updated
May 22, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share