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NCT04018027 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Cara Therapeutics.

Completed
Registry status
Phase 2
Development phase
401
Enrollment target

NCT04018027: Completed Phase 2 study, sponsored by Cara Therapeutics.

NCT04018027 is a Phase 2 study that has completed, run by Cara Therapeutics. The registered enrollment target is 401 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (202% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04018027, a Phase 2 study, has completed, sponsored by Cara Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
401 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG difelikefalin 0.25 mg
  • DRUG difelikefalin 0.5 mg
  • DRUG difelikefalin 1.0 mg

Trial Details

FieldValue
Enrollment Target 401 participants
Start Date 2019-06-29
Est. Completion 2021-04-01
Phase Phase 2
Cara Therapeutics

23 total trials

What the finished NCT04018027 record still lists

NCT04018027 is an interventional study that assigns participants to a tested intervention. The registered 401 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (202% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT04018027 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04018027 about?

NCT04018027 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis". 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.

What is the current status of trial NCT04018027?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 401 participants. The study started on 2019-06-29. Estimated completion is 2021-04-01.

What interventions are being tested in trial NCT04018027?

The interventions under investigation include: Placebo (DRUG), difelikefalin 0.25 mg (DRUG), difelikefalin 0.5 mg (DRUG), difelikefalin 1.0 mg (DRUG).

Who is sponsoring clinical trial NCT04018027?

This trial is sponsored by Cara Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04018027's enrollment target sits among peer trials

401 96th of 2000 higher than 1,905 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04018027, the US trial registry maintained by the National Library of Medicine. NCT04018027 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.