PruritusPhase 2NCT04706975
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)
A Phase 2 study testing difelikefalin 2.0 mg in people with Pruritus and Notalgia Paresthetica, run by Cara Therapeutics, Inc. at 36 sites in 2 countries.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with notalgia paresthetica 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, Notalgia Paresthetica
- What is being tested?
- difelikefalin 2.0 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 36 sitesin 2 countries
- Study dates
- 11 Jan 2021to 30 Jun 2022
- 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 Notalgia Paresthetica;
- Subject has a history of chronic pruritus due to Notalgia Paresthetica;
- 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 pruritus attributed to a cause other than Notalgia Paresthetica;
- 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
36 sites in 2 countries.
36 sites in 2 countries
United States26 sites
Cara Therapeutics Study Site
Bellaire, Texas, 77401
Cara Therapeutics Study Site
Charleston, South Carolina, 29407
Cara Therapeutics Study Site
Columbus, Ohio, 43215
Cara Therapeutics Study Site
Coral Gables, Florida, 33134
Cara Therapeutics Study Site
Cromwell, Connecticut, 06416
Cara Therapeutics Study Site
Fort Smith, Arkansas, 72916
Cara Therapeutics Study Site
Fountain Valley, California, 92708
Cara Therapeutics Study Site
High Point, North Carolina, 27262
Cara Therapeutics Study Site
Hot Springs, Arkansas, 71913
Cara Therapeutics Study Site
Indianapolis, Indiana, 46250
Cara Therapeutics Study Site
Los Angeles, California, 90033
Cara Therapeutics Study Site
Margate, Florida, 33063
Cara Therapeutics Study Site
Metairie, Louisiana, 70006
Cara Therapeutics Study Site
Miami, Florida, 33144
Cara Therapeutics Study Site
New York, New York, 10029
Cara Therapeutics Study Site
Norfolk, Virginia, 23502
Cara Therapeutics Study Site
North Miami Beach, Florida, 33162
Cara Therapeutics Study Site
Pflugerville, Texas, 78660
Cara Therapeutics Study Site
Plainfield, Indiana, 46168
Cara Therapeutics Study Site
Rogers, Arkansas, 72758
Cara Therapeutics Study Site
Salt Lake City, Utah, 84117
Cara Therapeutics Study Site
San Antonio, Texas, 78213
Cara Therapeutics Study Site
San Diego, California, 92122
Cara Therapeutics Study Site
Sandy Springs, Georgia, 30328
Cara Therapeutics Study Site
Santa Monica, California, 90404
Cara Therapeutics Study Site
Spokane, Washington, 99202
Canada10 sites
Cara Therapeutics Study Site
Markham, Ontario
Cara Therapeutics Study Site
Markham
Cara Therapeutics Study Site
Montreal, Quebec
Cara Therapeutics Study Site
Montreal
Cara Therapeutics Study Site
Peterborough, Ontario
Cara Therapeutics Study Site
Peterborough
Cara Therapeutics Study Site
Surrey, British Columbia
Cara Therapeutics Study Site
Surrey
Cara Therapeutics Study Site
Winnipeg, Manitoba
Cara Therapeutics Study Site
Winnipeg
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Adult Subjects With Notalgia Paresthetica
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with notalgia paresthetica and moderate to severe pruritus.
Read the detailed description
The study will consist of a 37-day Screening period, a 7-day Run-In period, a 8-week Placebo-Controlled Treatment period followed by a 4-week Active Extension period and a Follow Up visit approximately 14 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 2.0 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 period upon completion of the Week 8 visit assessments. All subjects in the Active Extension will receive difelikefalin (CR845).
- Conditions
- Pruritus, Notalgia Paresthetica
- Being tested
- difelikefalin 2.0 mg, Placebo
- Keywords
- Notalgia Paresthetica, Pruritus, CR845, Chronic Itch, difelikefalin, Itch, Itching, Generalized pruritus, NP, Neuropathic itch
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
difelikefalin 2.0 mgDrug
Also called CR845
Oral difelikefalin 2.0 mg administered twice daily
PlaceboDrug
Oral Placebo administered twice daily
| Study group | Role | What they receive |
|---|---|---|
| Difelikefalin 2.0 mg | Active comparator | Oral difelikefalin 2.0 mg tablet administered twice daily Receives: Drug: difelikefalin 2.0 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 Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 8.
Measured: Baseline, Week 8
Secondary outcomes (2)
Improvement in itch-related quality of life as assessed by the change from baseline to Week 8 in total Skindex-10 Scale score
Measured: Baseline, Week 8
Change from baseline in itch-related Sleep Disturbance Subscale measured by the Itch Medical Outcomes Study (MOS) at Week 8
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start11 Jan 2021
- Primary completion18 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cara Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nilam Shah, Study director, Cara Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706975
- Sponsor's protocol ID
- CR845-210601
- Status last verified
- May 2023
- First submitted
- 11 Jan 2021
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim BS, Bissonnette R, Nograles K, Munera C, Shah N, Jebara A, Cirulli J, Goncalves J, Lebwohl M; KOMFORT Trial Investigators. Phase 2 Trial of Difelikefalin in Notalgia Paresthetica. N Engl J Med. 2023 Feb 9;388(6):511-517. doi: 10.1056/NEJMoa2210699.
PubMed 36780675
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Adult Subjects With Notalgia Paresthetica
- ClinicalTrials.gov ID
- NCT04706975
- Acronym / sponsor ID
- CR845-210601
- Conditions
- Pruritus, Notalgia Paresthetica
- Keywords
- Notalgia Paresthetica, Pruritus, CR845, Chronic Itch, difelikefalin, Itch, Itching, Generalized pruritus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Cara Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 18 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 13 Jan 2021 (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, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with notalgia paresthetica and moderate to severe pruritus.
Detailed description
The study will consist of a 37-day Screening period, a 7-day Run-In period, a 8-week Placebo-Controlled Treatment period followed by a 4-week Active Extension period and a Follow Up visit approximately 14 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 2.0 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 period upon completion of the Week 8 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Difelikefalin 2.0 mg | Active comparator | Drug: difelikefalin 2.0 mgOral difelikefalin 2.0 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 (5 listed)
- Subject has clinically confirmed diagnosis of active Notalgia Paresthetica;
- Subject has a history of chronic pruritus due to Notalgia Paresthetica;
- Subject has moderate to severe pruritus;
- Female subject is not pregnant or nursing during any period of the study.
Key exclusion criteria (3 listed)
- Subject has pruritus attributed to a cause other than Notalgia Paresthetica;
- 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 2.0 mgAlso: CR845Oral difelikefalin 2.0 mg administered twice daily | Drug | Difelikefalin 2.0 mg |
| PlaceboOral Placebo administered twice daily | Drug | Placebo |
Primary outcome
Change from baseline in the weekly mean of the daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 8.
Time frame: Baseline, Week 8
2 secondary outcomes
Improvement in itch-related quality of life as assessed by the change from baseline to Week 8 in total Skindex-10 Scale score
Time frame: Baseline, Week 8
Change from baseline in itch-related Sleep Disturbance Subscale measured by the Itch Medical Outcomes Study (MOS) at Week 8
Time frame: Baseline, Week 8
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 22 May 2023.
- Derived from this study: PubMed 36780675Kim BS, Bissonnette R, Nograles K, Munera C, Shah N, Jebara A, Cirulli J, Goncalves J, Lebwohl M; KOMFORT Trial Investigators. Phase 2 Trial of Difelikefalin in Notalgia Paresthetica. N Engl J Med. 2023 Feb 9;388(6):511-517. doi: 10.1056/NEJMoa2210699.
- Individual participant dataSharing planned: No
Related trials for Pruritus
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Active, not recruiting
Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
Itch
Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
Histamine, Cowhage
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
Recruiting
Topographical Distribution of Itch and Pain Receptors
Pain, Itch
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.
Nilam Shah study director
Cara Therapeutics
36 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 2.0 mg in people with Pruritus and Notalgia Paresthetica, run by Cara Therapeutics, Inc. at 36 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 5 inclusion and 3 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 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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 Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 8. (time frame: Baseline, Week 8). 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 NCT04706975, which also lists 1 linked publication.
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 May 2023.