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Kappa Opioid Receptor Agonist

Difelikefalin 0.5 mg for Atopic Dermatitis (KARE Trial)

Phase 2
Waitlist Available
Research Sponsored by Cara Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

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.

Eligible Conditions
  • Atopic Dermatitis
  • Itching

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Difelikefalin 0.5 mgActive Control1 Intervention
Oral difelikefalin 0.5 mg tablet administered twice daily
Group II: Difelikefalin 1.0 mgActive Control1 Intervention
Oral difelikefalin 1.0 mg tablet administered twice daily
Group III: Difelikefalin 0.25 mgActive Control1 Intervention
Oral difelikefalin 0.25 mg tablet administered twice daily
Group IV: PlaceboPlacebo Group1 Intervention
Oral placebo tablet administered twice daily

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Who is running the clinical trial?

Cara Therapeutics, Inc.Lead Sponsor
23 Previous Clinical Trials
5,263 Total Patients Enrolled
Kristine NogralesStudy DirectorCara Therapeutics
~64 spots leftby Oct 2025
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