PruritusPhase 2KARENCT04018027
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis
A Phase 2 study testing difelikefalin 0.25 mg, difelikefalin 0.5 mg and difelikefalin 1.0 mg in people with Pruritus and Atopic Dermatitis, run by Cara Therapeutics, Inc. at 40 sites in 2 countries.
Trial 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. 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 difelikefalin 1.0 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 401 participants
- Where
- 40 sitesin 2 countries
- Study dates
- 29 Jun 2019to 1 Apr 2021
- Phase
- Phase 2
- 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 at least a 12-month history of AD;
- Subject has chronic itch 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
40 sites in 2 countries.
40 sites in 2 countries
United States38 sites
Cara Therapeutics Study Site
Anniston, Alabama, 36207
Cara Therapeutics Study Site 2
Austin, Texas, 78745
Cara Therapeutics Study Site
Austin, Texas, 78759
Cara Therapeutics Study Site
Aventura, Florida, 33180
Cara Therapeutics Study Site
Baton Rouge, Louisiana, 70809
Cara Therapeutics Study Site
Berlin, New Jersey, 08009
Cara Therapeutics Study Site
Birmingham, Alabama, 35209
Cara Therapeutics Study Site
Boise, Idaho, 83704
Cara Therapeutics Study Site 2
Boise, Idaho, 83713
Cara Therapeutics Study Site
Brighton, Massachusetts, 02135
Cara Therapeutics Study Site
Bryant, Arkansas, 72022
Cara Therapeutics Study Site
Cleveland, Ohio, 44122
Cara Therapeutics Study Site
Columbus, Georgia, 31904
Cara Therapeutics Study Site
Cromwell, Connecticut, 06416
Cara Therapeutics Study Site
Cypress, Texas, 77433
Cara Therapeutics Study Site
Dallas, Texas, 75225
Cara Therapeutics Study Site
Farmington, Connecticut, 06030
Cara Therapeutics Study Site
Fountain Valley, California, 92708
Cara Therapeutics Study Site
Horseheads, New York, 14845
Cara Therapeutics Study Site 2
Las Vegas, Nevada, 89119
Cara Therapeutics Study Site
Lomita, California, 90717
Cara Therapeutics Study Site
Medford, Oregon, 97504
Cara Therapeutics Study Site
Metairie, Louisiana, 70006
Cara Therapeutics Study Site 2
Miami, Florida, 33125
Cara Therapeutics Study Site
Miami, Florida, 33174
Cara Therapeutics Study Site
Miami Lakes, Florida, 33014
Cara Therapeutics Study Site
New Orleans, Louisiana, 70115
Cara Therapeutics Study Site
New York, New York, 10016
Cara Therapeutics Study Site
New York, New York, 10023
Cara Therapeutics Study Site
Ocala, Florida, 34470
Cara Therapeutics Study Site
Oklahoma City, Oklahoma, 73118
Cara Therapeutics Study Site
Rapid City, South Dakota, 57702
Cara Therapeutics Study Site
Richmond, Virginia, 23226
Cara Therapeutics Study Site
Salt Lake City, Utah, 84117
Cara Therapeutics Study Site
Sarasota, Florida, 34239
Cara Therapeutics Study Site
Scottsdale, Arizona, 85254
Cara Therapeutics Study Site
Sweetwater, Florida, 33172
Cara Therapeutics Study Site
Tulsa, Oklahoma, 74136
Canada2 sites
Cara Therapeutics Study Site
London, Ontario
Cara Therapeutics Study Site
Montreal, Quebec
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Adult Subjects With Atopic Dermatitis
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.
Read the detailed description
The study will consist of a 30-day Screening period, a 7-day Run-In period, a 12-week Placebo-Controlled Treatment period followed by a 4-week Active Extension period and a Follow Up visit approximately 7 days after the last dose of study drug.
All subjects will sign an informed consent form (ICF) and undergo screening for study eligibility.
Subjects will be randomized to receive either placebo or difelikefalin (CR845) tablets at a dose of 0.25 mg, 0.5 mg, or 1.0 mg, orally BID. Intake of the first dose of study drug will be at Day 1.
Subjects who complete the Placebo-Controlled Treatment period of the study will transition into the Active Extension upon completion of the Week 12 visit assessments. All subjects in the Active Extension will receive difelikefalin (CR845).
- Conditions
- Pruritus, Atopic Dermatitis
- Being tested
- difelikefalin 0.25 mg, difelikefalin 0.5 mg, difelikefalin 1.0 mg, Placebo
- 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 administered twice daily
difelikefalin 0.5 mgDrug
Also called CR845
Oral difelikefalin 0.5 mg administered twice daily
difelikefalin 1.0 mgDrug
Also called CR845
Oral difelikefalin 1.0 mg administered twice daily
PlaceboDrug
Oral Placebo administered twice daily
| Study group | Role | What they receive |
|---|---|---|
| Difelikefalin 0.25 mg | Active comparator | Oral difelikefalin 0.25 mg tablet administered twice daily Receives: Drug: difelikefalin 0.25 mg |
| Difelikefalin 0.5 mg | Active comparator | Oral difelikefalin 0.5 mg tablet administered twice daily Receives: Drug: difelikefalin 0.5 mg |
| Difelikefalin 1.0 mg | Active comparator | Oral difelikefalin 1.0 mg tablet administered twice daily Receives: Drug: difelikefalin 1.0 mg |
| Placebo | Placebo comparator | Oral placebo tablet administered twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale (I-NRS) score at Week 12.
Measured: Baseline, Week 12
Secondary outcomes (5)
Reduction of itch intensity as assessed by the 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
Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in 5-D Itch Scale score
Measured: Baseline, Week 12
Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in total Skindex-10 Scale score
Measured: Baseline, Week 12
Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in Sleep Quality Assessment.
Measured: Baseline, Week 12
Percent of subjects with adverse events.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start29 Jun 2019
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cara Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristine Nograles, Study director, Cara Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018027
- Sponsor's protocol ID
- CR845-210501
- Acronym
- KARE
- Status last verified
- Mar 2022
- First submitted
- 9 Jul 2019
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Adult Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04018027
- Acronym / sponsor ID
- KARE / CR845-210501
- Conditions
- Pruritus, Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Pruritus, CR845, Chronic Itch, difelikefalin, Itch, Itching, Generalized pruritus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Cara Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 12 Jul 2019 (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.
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.
Detailed description
The study will consist of a 30-day Screening period, a 7-day Run-In period, a 12-week Placebo-Controlled Treatment period followed by a 4-week Active Extension period and a Follow Up visit approximately 7 days after the last dose of study drug.
All subjects will sign an informed consent form (ICF) and undergo screening for study eligibility.
Subjects will be randomized to receive either placebo or difelikefalin (CR845) tablets at a dose of 0.25 mg, 0.5 mg, or 1.0 mg, orally BID. Intake of the first dose of study drug will be at Day 1.
Subjects who complete the Placebo-Controlled Treatment period of the study will transition into the Active Extension upon completion of the Week 12 visit assessments. All subjects in the Active Extension will receive difelikefalin (CR845).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Difelikefalin 0.25 mg | Active comparator | Drug: difelikefalin 0.25 mgOral difelikefalin 0.25 mg tablet administered twice daily |
| Difelikefalin 0.5 mg | Active comparator | Drug: difelikefalin 0.5 mgOral difelikefalin 0.5 mg tablet administered twice daily |
| Difelikefalin 1.0 mg | Active comparator | Drug: difelikefalin 1.0 mgOral difelikefalin 1.0 mg tablet administered twice daily |
| Placebo | Placebo comparator | Drug: PlaceboOral placebo tablet administered twice daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has clinically confirmed diagnosis of active AD;
- Subject has at least a 12-month history of AD;
- Subject has chronic itch 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 administered twice daily | Drug | Difelikefalin 0.25 mg |
| difelikefalin 0.5 mgAlso: CR845Oral difelikefalin 0.5 mg administered twice daily | Drug | Difelikefalin 0.5 mg |
| difelikefalin 1.0 mgAlso: CR845Oral difelikefalin 1.0 mg administered twice daily | Drug | Difelikefalin 1.0 mg |
| PlaceboOral Placebo administered twice daily | Drug | Placebo |
Primary outcome
Change from baseline in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale (I-NRS) score at Week 12.
Time frame: Baseline, Week 12
5 secondary outcomes
Reduction of itch intensity as assessed by the 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
Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in 5-D Itch Scale score
Time frame: Baseline, Week 12
Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in total Skindex-10 Scale score
Time frame: Baseline, Week 12
Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in Sleep Quality Assessment.
Time frame: Baseline, Week 12
Percent of subjects with adverse events.
Time frame: Baseline, Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Kristine Nograles study director
Cara Therapeutics
40 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing difelikefalin 0.25 mg, difelikefalin 0.5 mg and difelikefalin 1.0 mg in people with Pruritus and Atopic Dermatitis, run by Cara Therapeutics, Inc. at 40 sites in 2 countries.
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 6 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: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale (I-NRS) score at Week 12. (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2022.