PruritusPhase 3KIND-1NCT05387707

Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis

A Phase 3 study testing difelikefalin 0.25 mg, difelikefalin 0.5 mg and TCS Cream in people with Pruritus and Atopic Dermatitis, run by Cara Therapeutics, Inc. at 61 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a two-part, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral difelikefalin as adjunct therapy to a topical corticosteroid (TCS) for moderate-to-severe pruritus in adult subjects with atopic dermatitis (AD). Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Pruritus, Atopic Dermatitis
What is being tested?: difelikefalin 0.25 mg, difelikefalin 0.5 mg and TCS Cream
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 287 participants
Where: 61 sitesUnited States
Study dates: 16 Aug 2022to 2 Feb 2024
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

To be eligible for inclusion into the study, a patient must meet the following criteria:
Subject has clinically confirmed diagnosis of active AD;
Subject has chronic pruritus related to AD;
Subject has moderate to severe pruritus;
Female subject is not pregnant or nursing during any period of the study.

Who cannot join

A patient will be excluded from the study if any of the following criteria are met:
Subject has clinically infected AD;
Subject has pruritus attributed to a cause other than AD;
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.

Trial locations and contacts

61 sites in 1 country.

City, postcode or hospital

61 sites in 1 country

United States61 sites

Cara Therapeutics Study Site
Arlington, Texas, 76011
Cara Therapeutics Study Site
Athens, Ohio, 45701
Cara Therapeutics Study Site
Auburn Hills, Michigan, 48326
Cara Therapeutics Study Site
Austin, Texas, 78759
Cara Therapeutics Study Site
Baton Rouge, Louisiana, 70809
Cara Therapeutics Study Site
Bellaire, Texas, 77401
Cara Therapeutics Study Site
Bexley, Ohio, 43209
Cara Therapeutics Study Site
Boardman, Ohio, 44512
Cara Therapeutics Study Site
Brandon, Florida, 33511
Cara Therapeutics Study Site
Brighton, Massachusetts, 02135
Cara Therapeutics Study Site
Charleston, South Carolina, 29407
Cara Therapeutics Study Site
Clinton Township, Michigan, 48038
Cara Therapeutics Study Site
Coral Gables, Florida, 33134
Cara Therapeutics Study Site
Delray Beach, Florida, 33484
Cara Therapeutics Study Site
Denver, Colorado, 80210
Cara Therapeutics Study Site
Detroit, Michigan, 48202
Cara Therapeutics Study Site
Fort Smith, Arkansas, 72916
Cara Therapeutics Study Site
Fountain Valley, California, 92708
Cara Therapeutics Study Site
Hackensack, New Jersey, 07601
Cara Therapeutics Study Site
Hollywood, Florida, 33021
Cara Therapeutics Study Site
Houma, Louisiana, 70364
Cara Therapeutics Study Site
Houston, Texas, 77004
Cara Therapeutics Study Site
Huntersville, North Carolina, 28078
Cara Therapeutics Study Site
Indianapolis, Indiana, 46250
Cara Therapeutics Study Site
Knoxville, Tennessee, 37909
Cara Therapeutics Study Site
Lomita, California, 90717
Cara Therapeutics Study Site
Los Angeles, California, 90033
Cara Therapeutics Study Site
Louisville, Kentucky, 40241
Cara Therapeutics Study Site
Marietta, Georgia, 30060
Cara Therapeutics Study Site
Metairie, Louisiana, 70006
Cara Therapeutics Study Site
Morgantown, West Virginia, 26505
Cara Therapeutics Study Site
New Orleans, Louisiana, 70115
Cara Therapeutics Study Site
North Miami Beach, Florida, 33162
Cara Therapeutics Study Site
Oklahoma City, Oklahoma, 73118
Cara Therapeutics Study Site
Oklahoma City, Oklahoma, 73170
Cara Therapeutics Study Site
Orlando, Florida, 32819
Cara Therapeutics Study Site
Overland Park, Kansas, 66210
Cara Therapeutics Study Site
Philadelphia, Pennsylvania, 19103
Cara Therapeutics Study Site
Plainfield, Indiana, 46168
Cara Therapeutics Study Site
Plymouth Meeting, Pennsylvania, 19462
Cara Therapeutics Study Site
Raleigh, North Carolina, 27617
Cara Therapeutics Study Site
Redwood City, California, 94063
Cara Therapeutics Study Site
Rockville, Maryland, 20850
Cara Therapeutics Study Site
Rogers, Arkansas, 72758
Cara Therapeutics Study Site
Sacramento, California, 95815
Cara Therapeutics Study Site
Saint Augustine, Florida, 32080
Cara Therapeutics Study Site
San Antonio, Texas, 78209
Cara Therapeutics Study Site
San Diego, California, 92123
Cara Therapeutics Study Site 2
Santa Monica, California, 90404
Cara Therapeutics Study Site
Santa Monica, California, 90404
Cara Therapeutics Study Site
Scottsdale, Arizona, 85260
Cara Therapeutics Study Site
South Bend, Indiana, 46617
Cara Therapeutics Study Site
Spokane, Washington, 99202
Cara Therapeutics Study Site
Springville, Utah, 84663
Cara Therapeutics Study Site
St. Petersburg, Florida, 33709
Cara Therapeutics Study Site
Sugarloaf, Pennsylvania, 18249
Cara Therapeutics Study Site
Sweetwater, Florida, 33172
Cara Therapeutics Study Site
Tampa, Florida, 33607
Cara Therapeutics Study Site
Thompson's Station, Tennessee, 37179
Cara Therapeutics Study Site
Valencia, California, 91355
Cara Therapeutics Study Site
Waterford, Michigan, 48328

Other trials in United States

About this study

Official title: A Two-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate-to-Severe Pruritus in Adult Subjects With Atopic Dermatitis

Read the detailed description

Part A of this study includes a 12-week Double-blind Treatment Period and a 52-week Open-label Extension Period. Subjects will be randomized to receive oral difelikefalin 0.25 mg tablets BID plus TCS cream, difelikefalin 0.5 mg tablets BID plus TCS cream, placebo tablets BID plus TCS cream or placebo tablets BID plus vehicle cream.

Part B of this study includes a 12-week Double-blind Treatment Period and 52-week Open-label Extension Period. Subjects will be randomized to receive oral difelikefalin 0.25 mg or 0.5 mg tablets BID plus TCS cream or oral placebo tablets BID plus TCS cream. Part A results at week 12 will inform Part B.

Subjects who participated in Part A of the study may not participate in Part B.

All subjects will sign an informed consent form (ICF) and undergo screening for study eligibility.

Conditions: Pruritus, Atopic Dermatitis
Being tested: difelikefalin 0.25 mg, difelikefalin 0.5 mg, TCS Cream, Placebo, Vehicle Cream
Keywords: Atopic Dermatitis, Pruritus, CR845, Chronic Itch, difelikefalin, Itch, Itching, Generalized pruritus, Eczema
Medical subject headings: Pruritus, Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

difelikefalin 0.25 mgDrug
Also called CR845
Oral difelikefalin 0.25 mg tablets administered twice daily
difelikefalin 0.5 mgDrug
Also called CR845
Oral difelikefalin 0.5 mg tablets administered twice daily
TCS CreamDrug
TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed
PlaceboDrug
Oral Placebo tablets administered twice daily
Vehicle CreamDrug
Vehicle Cream applied by study subjects to skin lesions once a day until control is achieved, then as needed

Study groups in NCT05387707
Study group	Role	What they receive
Difelikefalin 0.25 mg tablets plus TCS cream	Experimental	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. Receives: Drug: difelikefalin 0.25 mg; Drug: TCS Cream
Difelikefalin 0.5 mg tablets plus TCS cream	Experimental	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. Receives: Drug: difelikefalin 0.5 mg; Drug: TCS Cream
Placebo tablets plus TCS cream	Active comparator	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 Receives: Drug: TCS Cream; Drug: Placebo
Placebo tablets plus Vehicle cream (Part A only)	Placebo comparator	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 Receives: Drug: Placebo; Drug: Vehicle Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of patients achieving an improvement from baseline ≥4 points with respect to the weekly mean of the daily 24-hour I-NRS score at Week 12
Measured: Week 12

Secondary outcomes (9)

Proportion of subjects achieving ≥ 4 point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 4
Measured: Week 4
Proportion of subjects with ≥ 3 point improvement from baseline in the weekly mean of the daily 24-hour Sleep Disturbance NRS score at the end of Week 12 (among subjects with a Sleep Disturbance NRS score of > 3 at baseline)
Measured: Week 12
Proportion of subjects achieving ≥ 4 point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 2
Measured: Week 2
Proportion of subjects achieving ≥ 4 point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 1
Measured: Week 1
Mean change and mean percent change from baseline in EASI score at Week 12.
Measured: Week 12
Proportion of subjects achieving a vIGA-ADTM score of clear (0) or almost clear (1) with a 2-point improvement from baseline at Week 12 (among subjects with a vIGA-ADTM score ≥ 3 at Day 1)
Measured: Week 12
Proportion of subjects achieving a vIGA-ADTM score of clear (0) or almost clear (1) with a 2-point improvement from baseline at Week 12 (among subjects with a vIGA-ADTM score ≥ 2 at Day 1)
Measured: Week 12
Proportion of subjects achieving at least ≥ 3-point improvement in the Skin Pain NRS score at Week 12 (among subjects with a Skin Pain NRS score > 3 at Day 1)
Measured: Week 12
Proportion of subjects with ≥ 4 point improvement from baseline in Dermatology Life Quality Index (DLQI) score at Week 12 (among subjects with DLQI score > 4 at baseline)
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Aug 20222 Feb 2024

First posted24 May 2022
Study start16 Aug 2022
Primary completion2 Feb 2024
Study completion2 Feb 2024

Why it stopped: In Part A of the study, oral difelikefalin as adjunct to topical corticosteroids (TCS) did not demonstrate meaningful clinical benefit compared to TCS alone.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PruritusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Part A includes 4 arms and Part B includes 2 arms.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 287 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05387707
Sponsor's protocol ID: CR845-310501
Acronym: KIND-1
Status last verified: Feb 2024
First submitted: 19 May 2022
Last updated: 22 Feb 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
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Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
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RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
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Recruiting
Topographical Distribution of Itch and Pain Receptors
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All Pruritus trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate-to-Severe Pruritus in Adult Subjects With Atopic Dermatitis
ClinicalTrials.gov ID: NCT05387707
Acronym / sponsor ID: KIND-1 / CR845-310501
Conditions: Pruritus, Atopic Dermatitis
Keywords: Atopic Dermatitis, Pruritus, CR845, Chronic Itch, difelikefalin, Itch, Itching, Generalized pruritus
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: In Part A of the study, oral difelikefalin as adjunct to topical corticosteroids (TCS) did not demonstrate meaningful clinical benefit compared to TCS alone.
Enrolment: 287 participants (actual)
Lead sponsor: Cara Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 16 Aug 2022 (actual)
Primary completion: 2 Feb 2024 (actual)
Study completion: 2 Feb 2024 (actual)
First posted: 24 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Subjects who participated in Part A of the study may not participate in Part B.

All subjects will sign an informed consent form (ICF) and undergo screening for study eligibility.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4
Model description: Part A includes 4 arms and Part B includes 2 arms.

Arm	Type	Receives
Difelikefalin 0.25 mg tablets plus TCS cream	Experimental	Drug: difelikefalin 0.25 mg, Drug: TCS CreamOral difelikefalin tablets administered twice daily. TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed.
Difelikefalin 0.5 mg tablets plus TCS cream	Experimental	Drug: difelikefalin 0.5 mg, Drug: TCS CreamOral difelikefalin tablets administered twice daily. TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed.
Placebo tablets plus TCS cream	Active comparator	Drug: TCS Cream, Drug: PlaceboOral placebo tablets administered twice daily. TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed
Placebo tablets plus Vehicle cream (Part A only)	Placebo comparator	Drug: Placebo, Drug: Vehicle CreamOral 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 may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subject has clinically confirmed diagnosis of active AD;
Subject has chronic pruritus related to AD;
Subject has moderate to severe pruritus;
Female subject is not pregnant or nursing during any period of the study.

Key exclusion criteria (4 listed)

Subject has clinically infected AD;
Subject has pruritus attributed to a cause other than AD;
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
difelikefalin 0.25 mgAlso: CR845Oral difelikefalin 0.25 mg tablets administered twice daily	Drug	Difelikefalin 0.25 mg tablets plus TCS cream
difelikefalin 0.5 mgAlso: CR845Oral difelikefalin 0.5 mg tablets administered twice daily	Drug	Difelikefalin 0.5 mg tablets plus TCS cream
TCS CreamTCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed	Drug	Difelikefalin 0.25 mg tablets plus TCS cream, Difelikefalin 0.5 mg tablets plus TCS cream, Placebo tablets plus TCS cream
PlaceboOral Placebo tablets administered twice daily	Drug	Placebo tablets plus TCS cream, Placebo tablets plus Vehicle cream (Part A only)
Vehicle CreamVehicle Cream applied by study subjects to skin lesions once a day until control is achieved, then as needed	Drug	Placebo tablets plus Vehicle cream (Part A only)

Primary outcome

Proportion of patients achieving an improvement from baseline ≥4 points with respect to the weekly mean of the daily 24-hour I-NRS score at Week 12
Time frame: Week 12

9 secondary outcomes

Proportion of subjects achieving ≥ 4 point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 4
Time frame: Week 4
Proportion of subjects with ≥ 3 point improvement from baseline in the weekly mean of the daily 24-hour Sleep Disturbance NRS score at the end of Week 12 (among subjects with a Sleep Disturbance NRS score of > 3 at baseline)
Time frame: Week 12
Proportion of subjects achieving ≥ 4 point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 2
Time frame: Week 2
Proportion of subjects achieving ≥ 4 point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 1
Time frame: Week 1
Mean change and mean percent change from baseline in EASI score at Week 12.
Time frame: Week 12
Proportion of subjects achieving a vIGA-ADTM score of clear (0) or almost clear (1) with a 2-point improvement from baseline at Week 12 (among subjects with a vIGA-ADTM score ≥ 3 at Day 1)
Time frame: Week 12
Proportion of subjects achieving a vIGA-ADTM score of clear (0) or almost clear (1) with a 2-point improvement from baseline at Week 12 (among subjects with a vIGA-ADTM score ≥ 2 at Day 1)
Time frame: Week 12
Proportion of subjects achieving at least ≥ 3-point improvement in the Skin Pain NRS score at Week 12 (among subjects with a Skin Pain NRS score > 3 at Day 1)
Time frame: Week 12
Proportion of subjects with ≥ 4 point improvement from baseline in Dermatology Life Quality Index (DLQI) score at Week 12 (among subjects with DLQI score > 4 at baseline)
Time frame: Week 12

Results and safety

The study was stopped early (reason given: In Part A of the study, oral difelikefalin as adjunct to topical corticosteroids (TCS) did not demonstrate meaningful clinical benefit compared to TCS alone.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
Individual participant dataSharing planned: No

Related trials for Pruritus

Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
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Active, not recruiting
Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
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Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
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RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
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Topographical Distribution of Itch and Pain Receptors
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cara Therapeutics study director

Cara Therapeutics

61 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing difelikefalin 0.25 mg, difelikefalin 0.5 mg and TCS Cream in people with Pruritus and Atopic Dermatitis, run by Cara Therapeutics, Inc. at 61 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients achieving an improvement from baseline ≥4 points with respect to the weekly mean of the daily 24-hour I-NRS score at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05387707.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.