Difelikefalin + Topical Corticosteroid for Eczema

(KIND-1 Trial)

Recruiting at63 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Cara Therapeutics, Inc.

Stay on Your Current Meds

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a pill called difelikefalin to see if it can help reduce severe itching in adults with eczema. The pill is taken along with a common eczema cream. Difelikefalin works by blocking the signals that cause itching.

Research Team

Cara Therapeutics

Principal Investigator

Cara Therapeutics

Eligibility Criteria

Adults with moderate to severe itching due to atopic dermatitis (AD) can join this study. They must not be pregnant or nursing and should have a confirmed diagnosis of active AD without clinical infection. Participants shouldn't have any other medical conditions that could risk their safety or affect the study's results.

Inclusion Criteria

I am not pregnant or breastfeeding.

It seems like there might be some missing information for me to accurately summarize this criterion. Can you provide more details or context?

I experience moderate to severe itching.

Exclusion Criteria

I have a skin infection due to atopic dermatitis.

My itching is not caused by atopic dermatitis.

Subject has any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results

Treatment Details

Interventions

• Difelikefalin (Opioid Analgesic)
• Topical Corticosteroid Cream (Corticosteroid)

Trial Overview The trial is testing oral difelikefalin in two doses (0.25 mg and 0.5 mg) as an add-on treatment alongside a topical corticosteroid cream for adults with itchy skin from AD. It's randomized and double-blind, meaning participants are assigned treatments by chance and neither they nor the researchers know who gets what.

Participant Groups

Group I: Difelikefalin 0.5 mg tablets plus TCS cream Experimental Treatment 2 Interventions

Oral difelikefalin tablets administered twice daily. TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed.

Group II: Difelikefalin 0.25 mg tablets plus TCS cream Experimental Treatment 2 Interventions

Oral difelikefalin tablets administered twice daily. TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed.

Group III: Placebo tablets plus TCS cream Active Control 2 Interventions

Oral placebo tablets administered twice daily. TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed

Group IV: Placebo tablets plus Vehicle cream (Part A only) Placebo Group 2 Interventions

Oral placebo tablets administered twice daily. Vehicle cream applied by study subjects to skin lesions once a day until control is achieved, then as needed

Who Is Running the Clinical Trial?

Cara Therapeutics, Inc.

Lead Sponsor

Trials

24

Recruited

5,100+