Difelikefalin + Topical Corticosteroid for Eczema

(KIND-1 Trial)

Recruiting at 63 trial locations

Overseen By Cara Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Cara Therapeutics, Inc.

Must be taking: Topical corticosteroids

Disqualifiers: Infected AD, Non-AD pruritus, others

Stay on Your Current Meds You can continue your current medications while participating

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

287 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the drug Difelikefalin + Topical Corticosteroid Cream for eczema?

The effectiveness of topical corticosteroids for eczema is supported by studies showing significant improvement in skin lesions, with over 80% of patients reporting good or excellent results. Additionally, intermittent use of corticosteroids has been shown to be effective while reducing the amount of medication needed. ^{1 2 3 4 5}

Is the combination of Difelikefalin and Topical Corticosteroid safe for treating eczema?

Topical corticosteroids are generally considered safe for treating eczema in both adults and children, according to a review of safety data. However, the safety of Difelikefalin in combination with topical corticosteroids specifically for eczema is not addressed in the available research. ^{6 7 8 9 10}

What makes the drug Difelikefalin + Topical Corticosteroid unique for treating eczema?

The combination of Difelikefalin with a topical corticosteroid is unique because it potentially offers a broader spectrum of treatment for eczema by combining the anti-itch properties of Difelikefalin with the anti-inflammatory effects of corticosteroids, which are commonly used for various skin conditions. This dual approach may enhance treatment effectiveness and reduce the need for higher doses of corticosteroids, which can have side effects. ^{1 2 7 11 12}

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive oral difelikefalin or placebo tablets BID plus TCS cream for 12 weeks

12 weeks

Open-label Extension

Participants may continue treatment with oral difelikefalin plus TCS cream for 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Difelikefalin
• Topical Corticosteroid Cream

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+

Findings from Research

In a pilot study involving Italian adults with eczema, the new non-steroid anti-inflammatory cream showed effectiveness in reducing eczema severity, with recovery rates of 58.3% in the non-steroid group compared to 91.7% in the Hydrocortisone group when following the treatment protocol closely.

While Hydrocortisone Butyrate 0.1% Cream was more effective overall, the non-steroid cream demonstrated significant clinical improvement at each assessment point, suggesting it could be a viable long-term treatment option for eczema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non steroid treatment for eczema: results from a controlled and randomized study. De Waure, C., Cadeddu, C., Venditti, A., et al.[2015]

In a 3-week study involving 301 patients with eczematous dermatoses, once-daily applications of 0.05% diflorasone diacetate cream or ointment showed significant efficacy, with over 80% of patients rating their treatment as good or excellent.

The treatment was generally well-tolerated, with only 16 patients experiencing mild side effects like transient burning and stinging, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of once-daily applications of diflorasone diacetate in eczematous dermatoses. Squires, DJ., Masson, EL.[2017]

Topical corticosteroids (TCS) used for atopic eczema showed no significant increased risk of skin thinning in short-term studies, indicating they are generally safe for use in both adults and children.

While TCS may have a higher relative risk of skin thinning compared to topical calcineurin inhibitors, the overall long-term safety data is limited, suggesting that intermittent use of TCS is safe but requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of topical corticosteroids in atopic eczema: an umbrella review. Axon, E., Chalmers, JR., Santer, M., et al.[2023]

Doxepin 5% cream has been approved for relieving itching associated with eczema in adults and children over 12, providing a new treatment option beyond traditional methods like emollients and corticosteroids.

The review assesses both the efficacy and safety of doxepin cream, highlighting its potential role in managing eczema-related pruritus effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doxepin cream for eczema? [2019]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Non steroid treatment for eczema: results from a controlled and randomized study. [2015]

2. England pubmed.ncbi.nlm.nih.gov

An evaluation of once-daily applications of diflorasone diacetate in eczematous dermatoses. [2017]

3. Germany pubmed.ncbi.nlm.nih.gov

[Optimized interval treatment of eczema with fluprednidene. A multicenter double-blind study]. [2012]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The role of pimecrolimus cream 1% (Elidel)) in managing adult atopic eczema. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

General dermatologic use of hydroxamic acid. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Safety of topical corticosteroids in atopic eczema: an umbrella review. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

[A common and insidious side-effect: allergic contact dermatitis caused by bufexamac used in the treatment of dermatitis. Results from the Information Network of Departments of Dermatology (IDVK)]. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Epidemiological significance of bufexamac as a frequent and relevant contact sensitizer. [2019]

9. France pubmed.ncbi.nlm.nih.gov

[Severe contact dermatitis caused by Parfenac cream]. [2013]

10. England pubmed.ncbi.nlm.nih.gov

Allergic contact dermatitis from naftifine in a child without cross-reaction to terbinafine. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

[Clinical research on a new corticoid-containing topical drug]. [2013]

12. England pubmed.ncbi.nlm.nih.gov

Doxepin cream for eczema? [2019]