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NCT05387707 Clinical Trial

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

Atopic Dermatitis Clinical Trial

— KIND-1  

Official title:
A Two-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate-to-Severe Pruritus in Adult Subjects With Atopic Dermatitis

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT05387707
Other study ID # CR845-310501
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date August 16, 2022
Est. completion date February 2, 2024

Study information
Verified date February 2024
Source Cara Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

Description:

Part A of this study includes a 12-week Double-blind Treatment Period and a 52-week Open-label Extension Period. Subjects will be randomized to receive oral difelikefalin 0.25 mg tablets BID plus TCS cream, difelikefalin 0.5 mg tablets BID plus TCS cream, placebo tablets BID plus TCS cream or placebo tablets BID plus vehicle cream. Part B of this study includes a 12-week Double-blind Treatment Period and 52-week Open-label Extension Period. Subjects will be randomized to receive oral difelikefalin 0.25 mg or 0.5 mg tablets BID plus TCS cream or oral placebo tablets BID plus TCS cream. Part A results at week 12 will inform Part B. Subjects who participated in Part A of the study may not participate in Part B. All subjects will sign an informed consent form (ICF) and undergo screening for study eligibility.

Recruitment information / eligibility
Status Terminated
Enrollment 287
Est. completion date February 2, 2024
Est. primary completion date February 2, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• difelikefalin 0.25 mg
Oral difelikefalin 0.25 mg tablets administered twice daily
• difelikefalin 0.5 mg
Oral difelikefalin 0.5 mg tablets administered twice daily
• TCS Cream
TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed
• Placebo
Oral Placebo tablets administered twice daily
• Vehicle Cream
Vehicle Cream applied by study subjects to skin lesions once a day until control is achieved, then as needed

Locations
Country Name City State
United States Cara Therapeutics Study Site Arlington Texas
United States Cara Therapeutics Study Site Athens Ohio
United States Cara Therapeutics Study Site Auburn Hills Michigan
United States Cara Therapeutics Study Site Austin Texas
United States Cara Therapeutics Study Site Baton Rouge Louisiana
United States Cara Therapeutics Study Site Bellaire Texas
United States Cara Therapeutics Study Site Bexley Ohio
United States Cara Therapeutics Study Site Boardman Ohio
United States Cara Therapeutics Study Site Brandon Florida
United States Cara Therapeutics Study Site Brighton Massachusetts
United States Cara Therapeutics Study Site Charleston South Carolina
United States Cara Therapeutics Study Site Clinton Township Michigan
United States Cara Therapeutics Study Site Coral Gables Florida
United States Cara Therapeutics Study Site Delray Beach Florida
United States Cara Therapeutics Study Site Denver Colorado
United States Cara Therapeutics Study Site Detroit Michigan
United States Cara Therapeutics Study Site Fort Smith Arkansas
United States Cara Therapeutics Study Site Fountain Valley California
United States Cara Therapeutics Study Site Hackensack New Jersey
United States Cara Therapeutics Study Site Hollywood Florida
United States Cara Therapeutics Study Site Houma Louisiana
United States Cara Therapeutics Study Site Houston Texas
United States Cara Therapeutics Study Site Huntersville North Carolina
United States Cara Therapeutics Study Site Indianapolis Indiana
United States Cara Therapeutics Study Site Knoxville Tennessee
United States Cara Therapeutics Study Site Lomita California
United States Cara Therapeutics Study Site Los Angeles California
United States Cara Therapeutics Study Site Louisville Kentucky
United States Cara Therapeutics Study Site Marietta Georgia
United States Cara Therapeutics Study Site Metairie Louisiana
United States Cara Therapeutics Study Site Morgantown West Virginia
United States Cara Therapeutics Study Site New Orleans Louisiana
United States Cara Therapeutics Study Site North Miami Beach Florida
United States Cara Therapeutics Study Site Oklahoma City Oklahoma
United States Cara Therapeutics Study Site Oklahoma City Oklahoma
United States Cara Therapeutics Study Site Orlando Florida
United States Cara Therapeutics Study Site Overland Park Kansas
United States Cara Therapeutics Study Site Philadelphia Pennsylvania
United States Cara Therapeutics Study Site Plainfield Indiana
United States Cara Therapeutics Study Site Plymouth Meeting Pennsylvania
United States Cara Therapeutics Study Site Raleigh North Carolina
United States Cara Therapeutics Study Site Redwood City California
United States Cara Therapeutics Study Site Rockville Maryland
United States Cara Therapeutics Study Site Rogers Arkansas
United States Cara Therapeutics Study Site Sacramento California
United States Cara Therapeutics Study Site Saint Augustine Florida
United States Cara Therapeutics Study Site Saint Petersburg Florida
United States Cara Therapeutics Study Site San Antonio Texas
United States Cara Therapeutics Study Site San Diego California
United States Cara Therapeutics Study Site Santa Monica California
United States Cara Therapeutics Study Site 2 Santa Monica California
United States Cara Therapeutics Study Site Scottsdale Arizona
United States Cara Therapeutics Study Site South Bend Indiana
United States Cara Therapeutics Study Site Spokane Washington
United States Cara Therapeutics Study Site Springville Utah
United States Cara Therapeutics Study Site Sugarloaf Pennsylvania
United States Cara Therapeutics Study Site Sweetwater Florida
United States Cara Therapeutics Study Site Tampa Florida
United States Cara Therapeutics Study Site Thompson's Station Tennessee
United States Cara Therapeutics Study Site Valencia California
United States Cara Therapeutics Study Site Waterford Michigan

Sponsors (1)
Lead Sponsor Collaborator
Cara Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
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 Week 12
Secondary Proportion of subjects achieving = 4 point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 4 Week 4
Secondary 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) Week 12
Secondary Proportion of subjects achieving = 4 point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 2 Week 2
Secondary Proportion of subjects achieving = 4 point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 1 Week 1
Secondary Mean change and mean percent change from baseline in EASI score at Week 12. Week 12
Secondary 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) Week 12
Secondary 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) Week 12
Secondary 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) Week 12
Secondary 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) Week 12
See also
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