Clinical trial NCT05978063: Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Pruritus
Notalgia Paresthetica
Keywords: Notalgia Paresthetica
Pruritus
CR845
Chronic Itch
difelikefalin
Itch
Itching
Generalized pruritus
NP
Neuropathic itch
Lead sponsor: Cara Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-07
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part A includes 4 arms and Part B includes 2 arms.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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.

Primary outcomes:
measure: Proportion of subjects achieving ≥4-point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: 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
timeFrame: Baseline, Week 4
measure: 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
timeFrame: Baseline, Week 2
measure: 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
timeFrame: Baseline, Week 1
measure: Change from Baseline in the Numeric Rating Scale of Burning Sensation and Skin Tingling at Week 8 in Part B
timeFrame: Baseline, Week 8
measure: Proportion of Subjects with H-IGA of Clear or Almost Clear at Week 8 in Part B
timeFrame: Week 8
measure: Proportion of ≥4-point Improvement in Daily I-NRS at Day 2 in Part B
timeFrame: Day 2
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cara Therapeutics Study Site
state: Alabama
city: Phoenix
country: United States
facility: Cara Therapeutics Study Site
state: Arizona
city: Fayetteville
country: United States
facility: Cara Therapeutics Study Site
state: Arkansas
city: Hot Springs
country: United States
facility: Cara Therapeutics Study Site
state: Arkansas
city: Encino
country: United States
facility: Cara Therapeutics Study Site
state: California
city: Fountain Valley
country: United States
facility: Cara Therapeutics Study Site
state: California
city: Los Angeles
country: United States
facility: Cara Therapeutics Study Site
state: California
city: Northridge
country: United States
facility: Cara Therapeutics Study Site
state: California
city: Valencia
country: United States
facility: Cara Therapeutics Study Site
state: California
city: Coral Gables
country: United States
facility: Cara Therapeutics Study Site
state: Florida
city: Hollywood
country: United States
facility: Cara Therapeutics Study Site
state: Florida
city: Lutz
country: United States
facility: Cara Therapeutics Study Site
state: Florida
city: Margate
country: United States
facility: Cara Therapeutics Study Site
state: Florida
city: Tampa
country: United States
facility: Cara Therapeutics Study Site
state: Florida
city: Indianapolis
country: United States
facility: Cara Therapeutics Study Site
state: Indiana
city: Plainfield
country: United States
facility: Cara Therapeutics Study Site
state: Indiana
city: West Lafayette
country: United States
facility: Cara Therapeutics Study Site
state: Indiana
city: Baton Rouge
country: United States
facility: Cara Therapeutics Study Site
state: Louisiana
city: Baton Rouge
country: United States
facility: Cara Therapeutics Study Site
state: Louisiana
city: Metairie
country: United States
facility: Cara Therapeutics Study Site
state: Louisiana
city: New Orleans
country: United States
facility: Cara Therapeutics Study Site
state: Louisiana
city: Rockville
country: United States
facility: Cara Therapeutics Study Site
state: Maryland
city: Fort Gratiot
country: United States
facility: Cara Therapeutics Study Site
state: Michigan
city: Reno
country: United States
facility: Cara Therapeutics Study Site
state: Nevada
city: Portsmouth
country: United States
facility: Cara Therapeutics Study Site
state: New Hampshire
city: Verona
country: United States
facility: Cara Therapeutics Study Site
state: New Jersey
city: Fargo
country: United States
facility: Cara Therapeutics Study Site
state: North Dakota
city: Boardman
country: United States
facility: Cara Therapeutics Study Site
state: Ohio
city: Mason
country: United States
facility: Cara Therapeutics Study Site
state: Ohio
city: Pittsburgh
country: United States
facility: Cara Therapeutics Study Site
state: Pennsylvania
city: Charleston
country: United States
facility: Cara Therapeutics Study Site
state: South Carolina
city: Thompson's Station
country: United States
facility: Cara Therapeutics Study Site
state: Tennessee
city: Dallas
country: United States
facility: Cara Therapeutics Study Site
state: Texas
city: Houston
country: United States
facility: Cara Therapeutics Study Site
state: Texas
city: Pflugerville
country: United States
facility: Cara Therapeutics Study Site
state: Texas
city: San Antonio
country: United States
facility: Cara Therapeutics Study Site
state: Texas
city: Webster
country: United States
facility: Cara Therapeutics Study Site
state: Texas
city: Spokane
country: United States
facility: Cara Therapeutics Study Site
state: Washington
city: Oakville
country: Canada
facility: Cara Therapeutics Study Site
state: Ontario
city: Peterborough
country: Canada
facility: Cara Therapeutics Study Site
state: Ontario
city: Richmond Hill
country: Canada
facility: Cara Therapeutics Study Site
state: Ontario
city: Toronto
country: Canada
facility: Cara Therapeutics Study Site
state: Ontario
city: Sherbrooke
country: Canada
facility: Cara Therapeutics Study Site
state: Quebec
city: Montréal
country: Canada
facility: Cara Therapeutics Study Site
city: Oshawa
country: Canada
facility: Cara Therapeutics Study Site
city: Québec
country: Canada
facility: Cara Therapeutics Study Site
city: Bad Bentheim
country: Germany
facility: Cara Therapeutics Study Site
city: Berlin
country: Germany
facility: Cara Therapeutics Study Site
city: Heidelberg
country: Germany
facility: Cara Therapeutics Study Site
city: Langenau
country: Germany
facility: Cara Therapeutics Study Site 2
city: Langenau
country: Germany
facility: Cara Therapeutics Study Site
city: Katowice
country: Poland
facility: Cara Therapeutics Study Site 2
city: Katowice
country: Poland
facility: Cara Therapeutics Study Site
city: Sosnowiec
country: Poland
facility: Cara Therapeutics Study Site
city: Szczecin
country: Poland
facility: Cara Therapeutics Study Site
city: Wrocław
country: Poland
facility: Cara Therapeutics Study Site
city: Bilbao
country: Spain
facility: Cara Therapeutics Study Site
city: Madrid
country: Spain
facility: Cara Therapeutics Study Site
Study officials:
affiliation: Cara Therapeutics
name: Cara Therapeutics
role: STUDY_DIRECTOR
References: