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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 (KIND-1)

Primary Purpose

Pruritus, Atopic Dermatitis

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
difelikefalin 0.25 mg
difelikefalin 0.5 mg
TCS Cream
Placebo
Vehicle Cream
Sponsored by
Cara Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pruritus focused on measuring Atopic Dermatitis, Pruritus, CR845, Chronic Itch, difelikefalin, Itch, Itching, Generalized pruritus, Eczema

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cara Therapeutics Study SiteRecruiting
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

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)

Arm Description

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.

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.

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

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

Outcomes

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

Proportion of subjects achieving ≥ 4 point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at 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)
Proportion of subjects achieving ≥ 4 point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at 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
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 ≥ 3 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 ≥ 2 at Day 1)
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)
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)

Full Information

First Posted
May 19, 2022
Last Updated
May 30, 2023
Sponsor
Cara Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05387707
Brief Title
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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2022 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cara Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus, Atopic Dermatitis
Keywords
Atopic Dermatitis, Pruritus, CR845, Chronic Itch, difelikefalin, Itch, Itching, Generalized pruritus, Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Part A includes 4 arms and Part B includes 2 arms.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Difelikefalin 0.25 mg tablets plus TCS cream
Arm Type
Experimental
Arm Description
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.
Arm Title
Difelikefalin 0.5 mg tablets plus TCS cream
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo tablets plus TCS cream
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo tablets plus Vehicle cream (Part A only)
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
difelikefalin 0.25 mg
Other Intervention Name(s)
CR845
Intervention Description
Oral difelikefalin 0.25 mg tablets administered twice daily
Intervention Type
Drug
Intervention Name(s)
difelikefalin 0.5 mg
Other Intervention Name(s)
CR845
Intervention Description
Oral difelikefalin 0.5 mg tablets administered twice daily
Intervention Type
Drug
Intervention Name(s)
TCS Cream
Intervention Description
TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Placebo tablets administered twice daily
Intervention Type
Drug
Intervention Name(s)
Vehicle Cream
Intervention Description
Vehicle Cream applied by study subjects to skin lesions once a day until control is achieved, then as needed
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
Mean change and mean percent change from baseline in EASI score at Week 12.
Time Frame
Week 12
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cara Therapeutics
Phone
203-406-3700
Email
clinicaltrials.gov@caratherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cara Therapeutics
Organizational Affiliation
Cara Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Cara Therapeutics Study Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site 2
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Valencia
State/Province
California
ZIP/Postal Code
91355
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
32080
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70364
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Auburn Hills
State/Province
Michigan
ZIP/Postal Code
48326
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Waterford
State/Province
Michigan
ZIP/Postal Code
48328
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27617
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73170
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Sugarloaf
State/Province
Pennsylvania
ZIP/Postal Code
18249
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Thompson's Station
State/Province
Tennessee
ZIP/Postal Code
37179
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this 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

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