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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

NCT05387707 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 287

Last updated 2024-02-22

No results posted yet for this study

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

Interventions

DRUG

difelikefalin 0.25 mg

Oral difelikefalin 0.25 mg tablets administered twice daily

DRUG

difelikefalin 0.5 mg

Oral difelikefalin 0.5 mg tablets administered twice daily

DRUG

TCS Cream

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

DRUG

Placebo

Oral Placebo tablets administered twice daily

DRUG

Vehicle Cream

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

Sponsors & Collaborators

  • Cara Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Cara Therapeutics · Cara Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-16
Primary Completion
2024-02-02
Completion
2024-02-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05387707 on ClinicalTrials.gov