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

Short name KIND-1

NCTNCT05387707Other idCR845-310501

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: In Part A of the study, oral difelikefalin as adjunct to topical corticosteroids (TCS) did not demonstrate meaningful clinical benefit compared to TCS alone.

Overview

Status: Terminated
Phase: Phase 3
Enrollment: 287 participants (actual)
Sponsor: Cara Therapeutics, Inc. · Industry
Design: Randomized · Double masking
Countries: 1 country
United States
Start: 16 Aug 2022
Primary completion: 2 Feb 2024
Completion: 2 Feb 2024
First posted: 24 May 2022
Last update posted: 22 Feb 2024
Conditions: Pruritus · Atopic Dermatitis

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2022202320242025

Ph 3
KIND-1
NCT05387707
16 Aug 2022 to 2 Feb 2024
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a two-part, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral difelikefalin as adjunct therapy to a topical corticosteroid (TCS) for moderate-to-severe pruritus in adult subjects with atopic dermatitis (AD).

Interventions

difelikefalin 0.25 mgDrug
difelikefalin 0.5 mgDrug
TCS CreamDrug
PlaceboDrug
Vehicle CreamDrug

Arms4

Experimental
Difelikefalin 0.25 mg tablets plus TCS cream
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.
Experimental
Difelikefalin 0.5 mg tablets plus TCS cream
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.
Active comparator
Placebo tablets plus TCS cream
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
Placebo comparator
Placebo tablets plus Vehicle cream (Part A only)
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

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Time frame · Week 12

Secondary outcomes(9)

Proportion of subjects achieving ≥ 4 point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 4
Time frame · Week 4
Proportion of subjects with ≥ 3 point improvement from baseline in the weekly mean of the daily 24-hour Sleep Disturbance NRS score at the end of Week 12 (among subjects with a Sleep Disturbance NRS score of > 3 at baseline)
Time frame · Week 12
Proportion of subjects achieving ≥ 4 point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 2
Time frame · Week 2
Proportion of subjects achieving ≥ 4 point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 1
Time frame · Week 1
Mean change and mean percent change from baseline in EASI score at Week 12.
Time frame · 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 ≥ 3 at Day 1)
Time frame · 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)
Time frame · Week 12
Proportion of subjects achieving at least ≥ 3-point improvement in the Skin Pain NRS score at Week 12 (among subjects with a Skin Pain NRS score > 3 at Day 1)
Time frame · Week 12
Proportion of subjects with ≥ 4 point improvement from baseline in Dermatology Life Quality Index (DLQI) score at Week 12 (among subjects with DLQI score > 4 at baseline)
Time frame · Week 12

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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 AD; * Subject has chronic pruritus related to AD; * Subject has moderate to severe pruritus; * Female subject is not pregnant or nursing during any period of the study. Key Exclusion Criteria: A patient will be excluded from the study if any of the following criteria are met: * Subject has clinically infected AD; * Subject has pruritus attributed to a cause other than AD; * 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.

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