PruritusPhase 2/3NCT05978063

Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica

A Phase 2/3 study testing difelikefalin 2.0 mg tablets, difelikefalin 1.0 mg tablets and difelikefalin 0.25 mg tablets in people with Pruritus and Notalgia Paresthetica, run by Cara Therapeutics, Inc. at 58 sites in 5 countries.

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 2-part, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin for moderate-to-severe pruritus in adult subjects with NP. 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 tablets, difelikefalin 1.0 mg tablets and difelikefalin 0.25 mg tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 214 participants
Where: 58 sitesin 5 countries
Study dates: 1 Aug 2023to 7 May 2024
Phase: Phase 2/3
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 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

58 sites in 5 countries.

Country

City, postcode or hospital

58 sites in 5 countries

United States38 sites

Cara Therapeutics Study Site
Baton Rouge, Louisiana, 70808
Cara Therapeutics Study Site
Baton Rouge, Louisiana, 70809
Cara Therapeutics Study Site
Birmingham, Alabama, 35244
Cara Therapeutics Study Site
Boardman, Ohio, 44512
Cara Therapeutics Study Site
Charleston, South Carolina, 29425
Cara Therapeutics Study Site
Coral Gables, Florida, 33134
Cara Therapeutics Study Site
Dallas, Texas, 75230
Cara Therapeutics Study Site
Encino, California, 91436
Cara Therapeutics Study Site
Fargo, North Dakota, 58103
Cara Therapeutics Study Site
Fayetteville, Arkansas, 72703
Cara Therapeutics Study Site
Fort Gratiot, Michigan, 48059
Cara Therapeutics Study Site
Fountain Valley, California, 92708
Cara Therapeutics Study Site
Hollywood, Florida, 33021
Cara Therapeutics Study Site
Hot Springs, Arkansas, 71913
Cara Therapeutics Study Site
Houston, Texas, 77056
Cara Therapeutics Study Site
Indianapolis, Indiana, 46250
Cara Therapeutics Study Site
Los Angeles, California, 90045
Cara Therapeutics Study Site
Lutz, Florida, 33558
Cara Therapeutics Study Site
Margate, Florida, 33063
Cara Therapeutics Study Site
Mason, Ohio, 45040
Cara Therapeutics Study Site
Metairie, Louisiana, 70006
Cara Therapeutics Study Site
New Orleans, Louisiana, 70115
Cara Therapeutics Study Site
Northridge, California, 91324
Cara Therapeutics Study Site
Pflugerville, Texas, 78660
Cara Therapeutics Study Site
Phoenix, Arizona, 85032
Cara Therapeutics Study Site
Pittsburgh, Pennsylvania, 15213
Cara Therapeutics Study Site
Plainfield, Indiana, 46168
Cara Therapeutics Study Site
Portsmouth, New Hampshire, 03801
Cara Therapeutics Study Site
Reno, Nevada, 89509
Cara Therapeutics Study Site
Rockville, Maryland, 20850
Cara Therapeutics Study Site
San Antonio, Texas, 78213
Cara Therapeutics Study Site
Spokane, Washington, 99202
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
Verona, New Jersey, 07044
Cara Therapeutics Study Site
Webster, Texas, 77598
Cara Therapeutics Study Site
West Lafayette, Indiana, 47906

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Canada8 sites

Cara Therapeutics Study Site
Montreal
Cara Therapeutics Study Site
Oakville, Ontario
Cara Therapeutics Study Site
Oshawa
Cara Therapeutics Study Site
Peterborough, Ontario
Cara Therapeutics Study Site
Québec
Cara Therapeutics Study Site
Richmond Hill, Ontario
Cara Therapeutics Study Site
Sherbrooke, Quebec
Cara Therapeutics Study Site
Toronto, Ontario

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Germany5 sites

Cara Therapeutics Study Site
Bad Bentheim
Cara Therapeutics Study Site
Berlin
Cara Therapeutics Study Site
Heidelberg
Cara Therapeutics Study Site 2
Langenau
Cara Therapeutics Study Site
Langenau

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Poland5 sites

Cara Therapeutics Study Site 2
Katowice
Cara Therapeutics Study Site
Katowice
Cara Therapeutics Study Site
Sosnowiec
Cara Therapeutics Study Site
Szczecin
Cara Therapeutics Study Site
Wroclaw

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Spain2 sites

Cara Therapeutics Study Site
Bilbao
Cara Therapeutics Study Site
Madrid

Other trials in Spain

About this study

Official title: A 2-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate-to-Severe Pruritus in Adult Subjects With Notalgia Paresthetica

Read the detailed description

Part A of this study will evaluate the benefit-risk of 3 doses of difelikefalin compared to placebo. The dose with the best benefit-risk profile will be further evaluated in Part B. Part A of this study comprises a 28-day Screening Period, a 7-day Run-in Period, an 8-week Double-blind Treatment Period, a 2-week Treatment Discontinuation Period, and a Safety Follow-up Visit (14 days after the last dose of study treatment).

Part B of this study will evaluate the efficacy, safety, and tolerability of oral difelikefalin. The dose of oral difelikefalin to be assessed in Part B will depend on the results of Part A. Part B of this study comprises a 28-day Screening Period, a 7-day Run-in Period, an 8-week Double-blind Treatment Period, up to a 52-week OLE Period, and a Safety Follow-up Visit.

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, Notalgia Paresthetica
Being tested: difelikefalin 2.0 mg tablets, difelikefalin 1.0 mg tablets, difelikefalin 0.25 mg tablets, Placebo tablets
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 mg tabletsDrug
Also called CR845
Oral difelikefalin 2.0 mg administered twice daily
difelikefalin 1.0 mg tabletsDrug
Also called CR845
Oral difelikefalin 1.0 mg administered twice daily
difelikefalin 0.25 mg tabletsDrug
Also called CR845
Oral difelikefalin 0.25 mg administered twice daily
Placebo tabletsDrug
Oral Placebo administered twice daily

Study groups in NCT05978063
Study group	Role	What they receive
Difelikefalin 2.0 mg tablets	Active comparator	Oral difelikefalin 2.0 mg tablet administered twice daily Receives: Drug: difelikefalin 2.0 mg tablets
Difelikefalin 1.0 mg tablets	Active comparator	Oral difelikefalin 1.0 mg tablet administered twice daily Receives: Drug: difelikefalin 1.0 mg tablets
Difelikefalin 0.25 mg tablets	Active comparator	Oral difelikefalin 0.25 mg tablet administered twice daily Receives: Drug: difelikefalin 0.25 mg tablets
Placebo tablets	Placebo comparator	Oral placebo tablet administered twice daily Receives: Drug: Placebo tablets

What is being measured

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

Proportion of subjects achieving ≥4-point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score
Measured: Baseline, Week 8

Secondary outcomes (6)

Proportion of subjects achieving ≥4-point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 4 in Part B
Measured: Baseline, Week 4
Proportion of subjects achieving ≥4-point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 2 in Part B
Measured: Baseline, 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 in Part B
Measured: Baseline, Week 1
Change from Baseline in the Numeric Rating Scale of Burning Sensation and Skin Tingling at Week 8 in Part B
Measured: Baseline, Week 8
Proportion of Subjects with H-IGA of Clear or Almost Clear at Week 8 in Part B
Measured: Week 8
Proportion of ≥4-point Improvement in Daily I-NRS at Day 2 in Part B
Measured: Day 2

Timeline

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

1 Aug 20237 May 2024

First posted7 Aug 2023
Study start1 Aug 2023
Primary completion22 Apr 2024
Study completion7 May 2024

Why it stopped: In Part A of CR845-310601, oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo. The drug was generally well tolerated with a safety profile similar to prior trials.

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 2/3
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: 214 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05978063
Sponsor's protocol ID: CR845-310601
Status last verified: Jun 2024
First submitted: 25 Jul 2023
Last updated: 21 Jun 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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All Pruritus trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 2-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate-to-Severe Pruritus in Adult Subjects With Notalgia Paresthetica
ClinicalTrials.gov ID: NCT05978063
Acronym / sponsor ID: CR845-310601
Conditions: Pruritus, Notalgia Paresthetica
Keywords: Notalgia Paresthetica, Pruritus, CR845, Chronic Itch, difelikefalin, Itch, Itching, Generalized pruritus
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason stopped: In Part A of CR845-310601, oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo. The drug was generally well tolerated with a safety profile similar to prior trials.
Enrolment: 214 participants (actual)
Lead sponsor: Cara Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 1 Aug 2023 (actual)
Primary completion: 22 Apr 2024 (actual)
Study completion: 7 May 2024 (actual)
First posted: 7 Aug 2023 (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 2.0 mg tablets	Active comparator	Drug: difelikefalin 2.0 mg tabletsOral difelikefalin 2.0 mg tablet administered twice daily
Difelikefalin 1.0 mg tablets	Active comparator	Drug: difelikefalin 1.0 mg tabletsOral difelikefalin 1.0 mg tablet administered twice daily
Difelikefalin 0.25 mg tablets	Active comparator	Drug: difelikefalin 0.25 mg tabletsOral difelikefalin 0.25 mg tablet administered twice daily
Placebo tablets	Placebo comparator	Drug: Placebo tabletsOral 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 mg tabletsAlso: CR845Oral difelikefalin 2.0 mg administered twice daily	Drug	Difelikefalin 2.0 mg tablets
difelikefalin 1.0 mg tabletsAlso: CR845Oral difelikefalin 1.0 mg administered twice daily	Drug	Difelikefalin 1.0 mg tablets
difelikefalin 0.25 mg tabletsAlso: CR845Oral difelikefalin 0.25 mg administered twice daily	Drug	Difelikefalin 0.25 mg tablets
Placebo tabletsOral Placebo administered twice daily	Drug	Placebo tablets

Primary outcome

Proportion of subjects achieving ≥4-point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score
Time frame: Baseline, Week 8

6 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 in Part B
Time frame: Baseline, Week 4
Proportion of subjects achieving ≥4-point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 2 in Part B
Time frame: Baseline, 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 in Part B
Time frame: Baseline, Week 1
Change from Baseline in the Numeric Rating Scale of Burning Sensation and Skin Tingling at Week 8 in Part B
Time frame: Baseline, Week 8
Proportion of Subjects with H-IGA of Clear or Almost Clear at Week 8 in Part B
Time frame: Week 8
Proportion of ≥4-point Improvement in Daily I-NRS at Day 2 in Part B
Time frame: Day 2

Results and safety

The study was stopped early (reason given: In Part A of CR845-310601, oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo. The drug was generally well tolerated with a safety profile similar to prior trials.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
Individual participant dataSharing planned: No

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Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
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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

58 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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: stopped early, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Canada, Germany, Poland, Spain. 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 combined 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.

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 subjects achieving ≥4-point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score (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 NCT05978063.

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 21 Jun 2024.