← 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
5,491 Total Patients Enrolled
Cara TherapeuticsStudy DirectorCara Therapeutics
1 Previous Clinical Trials
440 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project require that participants be under a certain age?

"The target patient population for this clinical trial are individuals who are between 18-80 years old."

Answered by AI

Are there any specific eligibilities for this clinical trial?

"This trial is open to 280 people aged 18-80 who suffer from pruritus. In addition to this, the following criteria must be met: The patient has a clinically confirmed diagnosis of active AD; The patient has chronic pruritus related to AD; The patient has moderate to severe pruritus; Female subjects are not pregnant or nursing during any period of the study."

Answered by AI

What are the FDA's thoughts on Difelikefalin 0.25 mg tablets in conjunction with TCS cream?

"Difelikefalin 0.25 mg tablets plus TCS cream is in Phase 3 clinical trials, meaning that there is some evidence of its efficacy and it has been through multiple rounds of safety testing. As such, our team rates its safety as a 3 on a scale of 1 to 3."

Answered by AI

Are patients currently being recruited for this clinical trial?

"This trial is currently seeking participants, as reported on clinicaltrials.gov. The original posting date for the trial was 8/16/2022, and it was last edited on 9/28/2022."

Answered by AI

How many people are going to be a part of this clinical trial?

"Yes, the information on clinicaltrials.gov indicates that this study is actively looking for candidates. The clinical trial was initially posted on 8/16/2022 and was most recently edited on 9/28/2022. The trial is searching for 280 participants between 11 sites."

Answered by AI

In how many different medical facilities is this clinical trial managed?

"Presently, 11 sites are enrolling patients for this study. These locations include Marietta, Metairie and Baton Rouge. If you wish to participate in this research it would be best to select a site close to your residence to cut down on travel."

Answered by AI

Who else is applying?

What state do they live in?
Oklahoma
Illinois
What site did they apply to?
Cara Therapeutics Study Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis
2022. "Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05387707.
~108 spots leftby Apr 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