Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Oral Difelikefalin for Pruritus in Atopic Dermatitis
NCT04018027Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2019
- Primary completion
- Apr 2021
- Countries
- 2
- Sponsor
- Cara Therapeutics, Inc.
- Modality
- Peptides, Small Molecules
- Drugs
- difelikefalin
- Conditions
- atopic dermatitis (AD)
01
Overview
Phase 2, randomised, double-blind trial of difelikefalin in atopic dermatitis (AD) (4 arms), sponsored by Cara Therapeutics, Inc. Primary endpoint: Itch-Numeric Rating Scale at 12 weeks. Started Jun 2019; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Difelikefalin 0.25 mg
Oral difelikefalin 0.25 mg BID
Difelikefalin 0.5 mg
Oral difelikefalin 0.5 mg BID
Difelikefalin 1.0 mg
Oral difelikefalin 1.0 mg BID
Placebo
Oral Placebo BID
03
Who it enrols
Adult subjects with a clinically confirmed diagnosis of active atopic dermatitis (AD), at least a 12-month history of AD, chronic itch related to AD, and moderate to severe pruritus.
04
Endpoints
Primary
Itch-Numeric Rating Scale
Secondary
Itch-Numeric Rating Scale Response
5-D Itch Scale
Skindex-10 Scale
Sleep Quality Assessment
Adverse Events
05
Results
Not all primary endpoints met
Beyond the preview
Go deeper on NCT04018027.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT04018027.