Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis

NCT04018027 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: CR845-210501
• Study Type: interventional
• Target: 401
• Locations: 2 countries
• Sites: 40

Brief Summary

This is a multicenter, randomized, double-blind, 4-arm, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with atopic dermatitis (AD) and moderate to severe pruritus.

Conditions

Pruritus; Atopic Dermatitis

Keywords

Atopic Dermatitis; Pruritus; CR845; Chronic Itch; difelikefalin; Itch; Itching; Generalized pruritus; Eczema

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale (I-NRS) score at Week 12.

  Baseline, Week 12

Secondary Outcomes (5)

• Reduction of itch intensity as assessed by the 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

• Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in 5-D Itch Scale score

  Baseline, Week 12

• Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in total Skindex-10 Scale score

  Baseline, Week 12

• Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in Sleep Quality Assessment.

  Baseline, Week 12

• Percent of subjects with adverse events.

  Baseline, Week 12

Study Arms (4)

Difelikefalin 0.25 mg

ACTIVE COMPARATOR

Oral difelikefalin 0.25 mg tablet administered twice daily

Drug: difelikefalin 0.25 mg

Difelikefalin 0.5 mg

ACTIVE COMPARATOR

Oral difelikefalin 0.5 mg tablet administered twice daily

Drug: difelikefalin 0.5 mg

Difelikefalin 1.0 mg

ACTIVE COMPARATOR

Oral difelikefalin 1.0 mg tablet administered twice daily

Drug: difelikefalin 1.0 mg

Placebo

PLACEBO COMPARATOR

Oral placebo tablet administered twice daily

Drug: Placebo

Interventions

difelikefalin 0.25 mg DRUG

Oral difelikefalin 0.25 mg administered twice daily

Also known as: CR845

Difelikefalin 0.25 mg

difelikefalin 0.5 mg DRUG

Oral difelikefalin 0.5 mg administered twice daily

Also known as: CR845

Difelikefalin 0.5 mg

difelikefalin 1.0 mg DRUG

Oral difelikefalin 1.0 mg administered twice daily

Also known as: CR845

Difelikefalin 1.0 mg

Placebo DRUG

Oral Placebo administered twice daily

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has clinically confirmed diagnosis of active AD;
• Subject has at least a 12-month history of AD;
• Subject has chronic itch related to AD;
• Subject has moderate to severe pruritus;
• Female subject is not pregnant or nursing during any period of the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cara Therapeutics, Inc.: lead

Study Sites (40)

Cara Therapeutics Study Site

Anniston, Alabama, 36207, United States

Location

Cara Therapeutics Study Site

Birmingham, Alabama, 35209, United States

Location

Cara Therapeutics Study Site

Scottsdale, Arizona, 85254, United States

Location

Cara Therapeutics Study Site

Bryant, Arkansas, 72022, United States

Location

Cara Therapeutics Study Site

Fountain Valley, California, 92708, United States

Location

Cara Therapeutics Study Site

Lomita, California, 90717, United States

Location

Cara Therapeutics Study Site

Cromwell, Connecticut, 06416, United States

Location

Cara Therapeutics Study Site

Farmington, Connecticut, 06030, United States

Location

Cara Therapeutics Study Site

Aventura, Florida, 33180, United States

Location

Cara Therapeutics Study Site 2

Miami, Florida, 33125, United States

Location

Cara Therapeutics Study Site

Miami, Florida, 33174, United States

Location

Cara Therapeutics Study Site

Miami Lakes, Florida, 33014, United States

Location

Cara Therapeutics Study Site

Ocala, Florida, 34470, United States

Location

Cara Therapeutics Study Site

Sarasota, Florida, 34239, United States

Location

Cara Therapeutics Study Site

Sweetwater, Florida, 33172, United States

Location

Cara Therapeutics Study Site

Columbus, Georgia, 31904, United States

Location

Cara Therapeutics Study Site

Boise, Idaho, 83704, United States

Location

Cara Therapeutics Study Site 2

Boise, Idaho, 83713, United States

Location

Cara Therapeutics Study Site

Baton Rouge, Louisiana, 70809, United States

Location

Cara Therapeutics Study Site

Metairie, Louisiana, 70006, United States

Location

Cara Therapeutics Study Site

New Orleans, Louisiana, 70115, United States

Location

Cara Therapeutics Study Site

Brighton, Massachusetts, 02135, United States

Location

Cara Therapeutics Study Site 2

Las Vegas, Nevada, 89119, United States

Location

Cara Therapeutics Study Site

Berlin, New Jersey, 08009, United States

Location

Cara Therapeutics Study Site

Horseheads, New York, 14845, United States

Location

Cara Therapeutics Study Site

New York, New York, 10016, United States

Location

Cara Therapeutics Study Site

New York, New York, 10023, United States

Location

Cara Therapeutics Study Site

Cleveland, Ohio, 44122, United States

Location

Cara Therapeutics Study Site

Oklahoma City, Oklahoma, 73118, United States

Location

Cara Therapeutics Study Site

Tulsa, Oklahoma, 74136, United States

Location

Cara Therapeutics Study Site

Medford, Oregon, 97504, United States

Location

Cara Therapeutics Study Site

Rapid City, South Dakota, 57702, United States

Location

Cara Therapeutics Study Site 2

Austin, Texas, 78745, United States

Location

Cara Therapeutics Study Site

Austin, Texas, 78759, United States

Location

Cara Therapeutics Study Site

Cypress, Texas, 77433, United States

Location

Cara Therapeutics Study Site

Dallas, Texas, 75225, United States

Location

Cara Therapeutics Study Site

Salt Lake City, Utah, 84117, United States

Location

Cara Therapeutics Study Site

Richmond, Virginia, 23226, United States

Location

Cara Therapeutics Study Site

London, Ontario, Canada

Location

Cara Therapeutics Study Site

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Pruritus; Dermatitis, Atopic; Eczema

Interventions

difelikefalin

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Kristine Nograles

  Cara Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 12, 2019
• Study Start: June 29, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (38); CA (2)