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Opioid Receptor Agonist

CR845 0.25 mg Oral Tablet for Atopic Dermatitis

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 baseline, week 12
Awards & highlights
All Individual Drugs Already Approved

Summary

This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment Period, and a Follow-up Visit (approximately 7 days after the last dose of study drug).

Eligible Conditions
  • Atopic Dermatitis
  • Itching
  • Chronic Kidney Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score During Week 12
Secondary study objectives
Change From Baseline in 5-D Itch Scale Score at the End of Week 12
Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: CR845 1 mg Oral TabletExperimental Treatment1 Intervention
Oral CR845 1 mg to be taken orally once daily for 12 weeks
Group II: CR845 0.5 mg Oral TabletExperimental Treatment1 Intervention
Oral CR845 0.5 mg to be taken orally once daily for 12 weeks
Group III: CR845 0.25 mg Oral TabletExperimental Treatment1 Intervention
Oral CR845 0.25 mg to be taken orally once daily for 12 weeks
Group IV: Placebo Oral TabletPlacebo Group1 Intervention
Oral Placebo to be taken orally once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Difelikefalin
FDA approved
Difelikefalin
FDA approved
Difelikefalin
FDA approved

Find a Location

Who is running the clinical trial?

Cara Therapeutics, Inc.Lead Sponsor
23 Previous Clinical Trials
5,395 Total Patients Enrolled
Frédérique Menzaghi, PhDStudy DirectorCara Therapeutics
9 Previous Clinical Trials
1,877 Total Patients Enrolled
~37 spots leftby Nov 2025
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