# 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** · PHASE3 · TERMINATED · sponsor: **Cara Therapeutics, Inc.** · enrollment: 287 (actual)

## Conditions studied

- Pruritus
- Atopic Dermatitis

## Interventions

- **DRUG:** difelikefalin 0.25 mg
- **DRUG:** difelikefalin 0.5 mg
- **DRUG:** TCS Cream
- **DRUG:** Placebo
- **DRUG:** Vehicle Cream

## Key facts

- **NCT ID:** NCT05387707
- **Lead sponsor:** Cara Therapeutics, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2022-08-16
- **Primary completion:** 2024-02-02
- **Final completion:** 2024-02-02
- **Target enrollment:** 287 (ACTUAL)
- **Why stopped:** In Part A of the study, oral difelikefalin as adjunct to topical corticosteroids (TCS) did not demonstrate meaningful clinical benefit compared to TCS alone.
- **Last updated:** 2024-02-22


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05387707

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05387707, "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". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT05387707. Licensed CC0.

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