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

NCT05387707 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: CR845-310501
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 61

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).

Conditions

Pruritus; Atopic Dermatitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 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

  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)

  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

  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

  Week 1

• Mean change and mean percent change from baseline in EASI score at Week 12.

  Week 12

Study Arms (4)

Difelikefalin 0.25 mg tablets plus TCS cream

EXPERIMENTAL

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.

Drug: difelikefalin 0.25 mg; Drug: TCS Cream

Difelikefalin 0.5 mg tablets plus TCS cream

EXPERIMENTAL

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.

Drug: difelikefalin 0.5 mg; Drug: TCS Cream

Placebo tablets plus TCS cream

ACTIVE COMPARATOR

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

Drug: TCS Cream; Drug: Placebo

Placebo tablets plus Vehicle cream (Part A only)

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Vehicle Cream

Interventions

difelikefalin 0.25 mg DRUG

Oral difelikefalin 0.25 mg tablets administered twice daily

Also known as: CR845

Difelikefalin 0.25 mg tablets plus TCS cream

difelikefalin 0.5 mg DRUG

Oral difelikefalin 0.5 mg tablets administered twice daily

Also known as: CR845

Difelikefalin 0.5 mg tablets plus TCS cream

TCS Cream DRUG

TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed

Difelikefalin 0.25 mg tablets plus TCS cream; Difelikefalin 0.5 mg tablets plus TCS cream; Placebo tablets plus TCS cream

Placebo DRUG

Oral Placebo tablets administered twice daily

Placebo tablets plus TCS cream; Placebo tablets plus Vehicle cream (Part A only)

Vehicle Cream DRUG

Vehicle Cream applied by study subjects to skin lesions once a day until control is achieved, then as needed

Placebo tablets plus Vehicle cream (Part A only)

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 chronic pruritus 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 (61)

Cara Therapeutics Study Site

Scottsdale, Arizona, 85260, United States

Location

Cara Therapeutics Study Site

Fort Smith, Arkansas, 72916, United States

Location

Cara Therapeutics Study Site

Rogers, Arkansas, 72758, 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

Los Angeles, California, 90033, United States

Location

Cara Therapeutics Study Site

Redwood City, California, 94063, United States

Location

Cara Therapeutics Study Site

Sacramento, California, 95815, United States

Location

Cara Therapeutics Study Site

San Diego, California, 92123, United States

Location

Cara Therapeutics Study Site 2

Santa Monica, California, 90404, United States

Location

Cara Therapeutics Study Site

Santa Monica, California, 90404, United States

Location

Cara Therapeutics Study Site

Valencia, California, 91355, United States

Location

Cara Therapeutics Study Site

Denver, Colorado, 80210, United States

Location

Cara Therapeutics Study Site

Brandon, Florida, 33511, United States

Location

Cara Therapeutics Study Site

Coral Gables, Florida, 33134, United States

Location

Cara Therapeutics Study Site

Delray Beach, Florida, 33484, United States

Location

Cara Therapeutics Study Site

Hollywood, Florida, 33021, United States

Location

Cara Therapeutics Study Site

North Miami Beach, Florida, 33162, United States

Location

Cara Therapeutics Study Site

Orlando, Florida, 32819, United States

Location

Cara Therapeutics Study Site

Saint Augustine, Florida, 32080, United States

Location

Cara Therapeutics Study Site

St. Petersburg, Florida, 33709, United States

Location

Cara Therapeutics Study Site

Sweetwater, Florida, 33172, United States

Location

Cara Therapeutics Study Site

Tampa, Florida, 33607, United States

Location

Cara Therapeutics Study Site

Marietta, Georgia, 30060, United States

Location

Cara Therapeutics Study Site

Indianapolis, Indiana, 46250, United States

Location

Cara Therapeutics Study Site

Plainfield, Indiana, 46168, United States

Location

Cara Therapeutics Study Site

South Bend, Indiana, 46617, United States

Location

Cara Therapeutics Study Site

Overland Park, Kansas, 66210, United States

Location

Cara Therapeutics Study Site

Louisville, Kentucky, 40241, United States

Location

Cara Therapeutics Study Site

Baton Rouge, Louisiana, 70809, United States

Location

Cara Therapeutics Study Site

Houma, Louisiana, 70364, 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

Rockville, Maryland, 20850, United States

Location

Cara Therapeutics Study Site

Brighton, Massachusetts, 02135, United States

Location

Cara Therapeutics Study Site

Auburn Hills, Michigan, 48326, United States

Location

Cara Therapeutics Study Site

Clinton Township, Michigan, 48038, United States

Location

Cara Therapeutics Study Site

Detroit, Michigan, 48202, United States

Location

Cara Therapeutics Study Site

Waterford, Michigan, 48328, United States

Location

Cara Therapeutics Study Site

Hackensack, New Jersey, 07601, United States

Location

Cara Therapeutics Study Site

Huntersville, North Carolina, 28078, United States

Location

Cara Therapeutics Study Site

Raleigh, North Carolina, 27617, United States

Location

Cara Therapeutics Study Site

Athens, Ohio, 45701, United States

Location

Cara Therapeutics Study Site

Bexley, Ohio, 43209, United States

Location

Cara Therapeutics Study Site

Boardman, Ohio, 44512, United States

Location

Cara Therapeutics Study Site

Oklahoma City, Oklahoma, 73118, United States

Location

Cara Therapeutics Study Site

Oklahoma City, Oklahoma, 73170, United States

Location

Cara Therapeutics Study Site

Philadelphia, Pennsylvania, 19103, United States

Location

Cara Therapeutics Study Site

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Cara Therapeutics Study Site

Sugarloaf, Pennsylvania, 18249, United States

Location

Cara Therapeutics Study Site

Charleston, South Carolina, 29407, United States

Location

Cara Therapeutics Study Site

Knoxville, Tennessee, 37909, United States

Location

Cara Therapeutics Study Site

Thompson's Station, Tennessee, 37179, United States

Location

Cara Therapeutics Study Site

Arlington, Texas, 76011, United States

Location

Cara Therapeutics Study Site

Austin, Texas, 78759, United States

Location

Cara Therapeutics Study Site

Bellaire, Texas, 77401, United States

Location

Cara Therapeutics Study Site

Houston, Texas, 77004, United States

Location

Cara Therapeutics Study Site

San Antonio, Texas, 78209, United States

Location

Cara Therapeutics Study Site

Springville, Utah, 84663, United States

Location

Cara Therapeutics Study Site

Spokane, Washington, 99202, United States

Location

Cara Therapeutics Study Site

Morgantown, West Virginia, 26505, United States

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

• Cara Therapeutics

  Cara Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A includes 4 arms and Part B includes 2 arms.

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 24, 2022
• Study Start: August 16, 2022
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (61)