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

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ClinicalTrials.gov Identifier: NCT05978063
Recruitment Status : Recruiting
First Posted : August 7, 2023
Last Update Posted : February 22, 2024
Sponsor:
Information provided by (Responsible Party):
Cara Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pruritus Notalgia Paresthetica Drug: difelikefalin 2.0 mg tablets Drug: difelikefalin 1.0 mg tablets Drug: difelikefalin 0.25 mg tablets Drug: Placebo tablets Phase 2 Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Part A includes 4 arms and Part B includes 2 arms.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : August 1, 2023
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain Itching

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Difelikefalin 2.0 mg tablets
Oral difelikefalin 2.0 mg tablet administered twice daily
 Drug: difelikefalin 2.0 mg tablets
Oral difelikefalin 2.0 mg administered twice daily
Other Name: CR845
Active Comparator: Difelikefalin 1.0 mg tablets
Oral difelikefalin 1.0 mg tablet administered twice daily
 Drug: difelikefalin 1.0 mg tablets
Oral difelikefalin 1.0 mg administered twice daily
Other Name: CR845
Active Comparator: Difelikefalin 0.25 mg tablets
Oral difelikefalin 0.25 mg tablet administered twice daily
 Drug: difelikefalin 0.25 mg tablets
Oral difelikefalin 0.25 mg administered twice daily
Other Name: CR845
Placebo Comparator: Placebo tablets
Oral placebo tablet administered twice daily
 Drug: Placebo tablets
Oral Placebo administered twice daily


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Proportion of Subjects with H-IGA of Clear or Almost Clear at Week 8 in Part B [ Time Frame: Week 8 ]
  6. Proportion of ≥4-point Improvement in Daily I-NRS at Day 2 in Part B [ Time Frame: Day 2 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05978063


Contacts
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Contact: Cara Therapeutics 203-406-3700 clinicaltrials.gov@caratherapeutics.com

Locations
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Sponsors and Collaborators
Cara Therapeutics, Inc.
Investigators
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Study Director: Cara Therapeutics Cara Therapeutics
More Information
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Responsible Party: Cara Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05978063    
Other Study ID Numbers: CR845-310601
First Posted: August 7, 2023    Key Record Dates
Last Update Posted: February 22, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cara Therapeutics, Inc.:
Notalgia Paresthetica
Pruritus
CR845
Chronic Itch
difelikefalin
 Itch
Itching
Generalized pruritus
NP
Neuropathic itch
Additional relevant MeSH terms:
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Pruritus
Back Pain
Skin Diseases
 Skin Manifestations
Pain
Neurologic Manifestations