Recent Updates
Recently added Catalysts

difelikefalin

Phase 2

Pruritus | Small molecule | Dermatology |Cara Therapeutics, Inc.|Last Updated: May 22, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment527
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04706975Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)PHASE2 COMPLETED 126 — — Jan 11, 2021Jun 30, 2022May 22, 202336 United States, Canada
NCT04018027Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic DermatitisPHASE2 COMPLETED 401 — — Jun 29, 2019Apr 1, 2021Apr 4, 202240 United States, Canada
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
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
Change from baseline in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale (I-NRS) score at Week 12.
Baseline, Week 12
Secondary Endpoints
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
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
Week 12
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Difelikefalin 2.0 mgACTIVE_COMPARATOROral difelikefalin 2.0 mg tablet administered twice daily
PlaceboPLACEBO_COMPARATOROral placebo tablet administered twice daily
Difelikefalin 0.25 mgACTIVE_COMPARATOROral difelikefalin 0.25 mg tablet administered twice daily
Difelikefalin 0.5 mgACTIVE_COMPARATOROral difelikefalin 0.5 mg tablet administered twice daily
Difelikefalin 1.0 mgACTIVE_COMPARATOROral difelikefalin 1.0 mg tablet administered twice daily
Interventions
NameTypeDescription
difelikefalin 2.0 mgDRUGOral difelikefalin 2.0 mg administered twice daily
PlaceboDRUGOral Placebo administered twice daily
difelikefalin 0.25 mgDRUGOral difelikefalin 0.25 mg administered twice daily
difelikefalin 0.5 mgDRUGOral difelikefalin 0.5 mg administered twice daily
difelikefalin 1.0 mgDRUGOral difelikefalin 1.0 mg administered twice daily
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites36

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 Notalgia Paresthetica; * Subject has a history of chronic pruritus due to Notalgia Paresthetica; * Subject has moderate to severe ...

Countries:United StatesCanada
Unlock Eligibility Criteria