← Back to Search

Difelikefalin + Topical Corticosteroid for Eczema (KIND-1 Trial)

Phase 3
Waitlist Available
Research Sponsored by Cara Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has chronic pruritus related to AD;
Subject has moderate to severe pruritus;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

KIND-1 Trial Summary

This trial will test if a new drug can help relieve itchiness caused by atopic dermatitis, when used alongside a topical corticosteroid.

Who is the study for?
Adults with moderate to severe itching due to atopic dermatitis (AD) can join this study. They must not be pregnant or nursing and should have a confirmed diagnosis of active AD without clinical infection. Participants shouldn't have any other medical conditions that could risk their safety or affect the study's results.Check my eligibility
What is being tested?
The trial is testing oral difelikefalin in two doses (0.25 mg and 0.5 mg) as an add-on treatment alongside a topical corticosteroid cream for adults with itchy skin from AD. It's randomized and double-blind, meaning participants are assigned treatments by chance and neither they nor the researchers know who gets what.See study design
What are the potential side effects?
Possible side effects of difelikefalin may include nausea, dizziness, dry mouth, headache, constipation, vomiting, and sleepiness. The severity of these side effects can vary among individuals.

KIND-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have long-term itching due to atopic dermatitis.
Select...
I experience moderate to severe itching.
Select...
I am not pregnant or breastfeeding.
Select...
I have been diagnosed with active Alzheimer's disease.
Select...
I am not pregnant or breastfeeding.
Select...
I have moderate to severe itching.
Select...
I have been diagnosed with active Alzheimer's disease.
Select...
I have long-term itching due to atopic dermatitis.

KIND-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
Mean change and mean percent change from baseline in EASI score at Week 12.
Proportion of subjects achieving a vIGA-ADTM score of clear (0) or almost clear (1) with a 2-point improvement from baseline at Week 12 (among subjects with a vIGA-ADTM score ≥ 2 at Day 1)
Proportion of subjects achieving a vIGA-ADTM score of clear (0) or almost clear (1) with a 2-point improvement from baseline at Week 12 (among subjects with a vIGA-ADTM score ≥ 3 at Day 1)
+6 more

KIND-1 Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Difelikefalin 0.5 mg tablets plus TCS creamExperimental Treatment2 Interventions
Oral difelikefalin tablets administered twice daily. TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed.
Group II: Difelikefalin 0.25 mg tablets plus TCS creamExperimental Treatment2 Interventions
Oral difelikefalin tablets administered twice daily. TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed.
Group III: Placebo tablets plus TCS creamActive Control2 Interventions
Oral placebo tablets administered twice daily. TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed
Group IV: Placebo tablets plus Vehicle cream (Part A only)Placebo Group2 Interventions
Oral placebo tablets administered twice daily. Vehicle cream applied by study subjects to skin lesions once a day until control is achieved, then as needed
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Difelikefalin
FDA approved
Difelikefalin
FDA approved
TCS Cream
2015
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

Cara Therapeutics, Inc.Lead Sponsor
23 Previous Clinical Trials
5,377 Total Patients Enrolled
Cara TherapeuticsStudy DirectorCara Therapeutics
2 Previous Clinical Trials
726 Total Patients Enrolled

Media Library

Topical Corticosteroid Cream Clinical Trial Eligibility Overview. Trial Name: NCT05387707 — Phase 3
Itching Research Study Groups: Difelikefalin 0.25 mg tablets plus TCS cream, Difelikefalin 0.5 mg tablets plus TCS cream, Placebo tablets plus TCS cream, Placebo tablets plus Vehicle cream (Part A only)
Itching Clinical Trial 2023: Topical Corticosteroid Cream Highlights & Side Effects. Trial Name: NCT05387707 — Phase 3
Topical Corticosteroid Cream 2023 Treatment Timeline for Medical Study. Trial Name: NCT05387707 — Phase 3
~104 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top