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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 is a Phase 2 study that has completed, run by Cara Therapeutics. The registered enrollment target is 401 participants.

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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

Sponsor

Cara Therapeutics

23 total trials

What the Registry Record Tells You About NCT04018027

The ClinicalTrials.gov registry entry for NCT04018027 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 401 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cara Therapeutics, which has 23 total studies on file at ClinicalTrials.gov.

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

NCT04018027 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.