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

NCT05978063 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: CR845-310601
• Study Type: interventional
• Target: 214
• Locations: 5 countries
• Sites: 58

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.

Conditions

Pruritus; Notalgia Paresthetica

Keywords

Notalgia Paresthetica; Pruritus; CR845; Chronic Itch; difelikefalin; Itch; Itching; Generalized pruritus; NP; Neuropathic itch

Outcome Measures

Primary Outcomes (1)

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

  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

  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

  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

  Baseline, Week 1

• Change from Baseline in the Numeric Rating Scale of Burning Sensation and Skin Tingling at Week 8 in Part B

  Baseline, Week 8

• Proportion of Subjects with H-IGA of Clear or Almost Clear at Week 8 in Part B

  Week 8

Study Arms (4)

Difelikefalin 2.0 mg tablets

ACTIVE COMPARATOR

Oral difelikefalin 2.0 mg tablet administered twice daily

Drug: difelikefalin 2.0 mg tablets

Difelikefalin 1.0 mg tablets

ACTIVE COMPARATOR

Oral difelikefalin 1.0 mg tablet administered twice daily

Drug: difelikefalin 1.0 mg tablets

Difelikefalin 0.25 mg tablets

ACTIVE COMPARATOR

Oral difelikefalin 0.25 mg tablet administered twice daily

Drug: difelikefalin 0.25 mg tablets

Placebo tablets

PLACEBO COMPARATOR

Oral placebo tablet administered twice daily

Drug: Placebo tablets

Interventions

difelikefalin 2.0 mg tablets DRUG

Oral difelikefalin 2.0 mg administered twice daily

Also known as: CR845

Difelikefalin 2.0 mg tablets

difelikefalin 1.0 mg tablets DRUG

Oral difelikefalin 1.0 mg administered twice daily

Also known as: CR845

Difelikefalin 1.0 mg tablets

difelikefalin 0.25 mg tablets DRUG

Oral difelikefalin 0.25 mg administered twice daily

Also known as: CR845

Difelikefalin 0.25 mg tablets

Placebo tablets DRUG

Oral Placebo administered twice daily

Placebo tablets

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cara Therapeutics, Inc.: lead

Study Sites (58)

Cara Therapeutics Study Site

Birmingham, Alabama, 35244, United States

Location

Cara Therapeutics Study Site

Phoenix, Arizona, 85032, United States

Location

Cara Therapeutics Study Site

Fayetteville, Arkansas, 72703, United States

Location

Cara Therapeutics Study Site

Hot Springs, Arkansas, 71913, United States

Location

Cara Therapeutics Study Site

Encino, California, 91436, United States

Location

Cara Therapeutics Study Site

Fountain Valley, California, 92708, United States

Location

Cara Therapeutics Study Site

Los Angeles, California, 90045, United States

Location

Cara Therapeutics Study Site

Northridge, California, 91324, United States

Location

Cara Therapeutics Study Site

Valencia, California, 91355, United States

Location

Cara Therapeutics Study Site

Coral Gables, Florida, 33134, United States

Location

Cara Therapeutics Study Site

Hollywood, Florida, 33021, United States

Location

Cara Therapeutics Study Site

Lutz, Florida, 33558, United States

Location

Cara Therapeutics Study Site

Margate, Florida, 33063, United States

Location

Cara Therapeutics Study Site

Tampa, Florida, 33607, United States

Location

Cara Therapeutics Study Site

Indianapolis, Indiana, 46250, United States

Location

Cara Therapeutics Study Site

Plainfield, Indiana, 46168, United States

Location

Cara Therapeutics Study Site

West Lafayette, Indiana, 47906, United States

Location

Cara Therapeutics Study Site

Baton Rouge, Louisiana, 70808, United States

Location

Cara Therapeutics Study Site

Baton Rouge, Louisiana, 70809, United States

Location

Cara Therapeutics Study Site

Metairie, Louisiana, 70006, United States

Location

Cara Therapeutics Study Site

New Orleans, Louisiana, 70115, United States

Location

Cara Therapeutics Study Site

Rockville, Maryland, 20850, United States

Location

Cara Therapeutics Study Site

Fort Gratiot, Michigan, 48059, United States

Location

Cara Therapeutics Study Site

Reno, Nevada, 89509, United States

Location

Cara Therapeutics Study Site

Portsmouth, New Hampshire, 03801, United States

Location

Cara Therapeutics Study Site

Verona, New Jersey, 07044, United States

Location

Cara Therapeutics Study Site

Fargo, North Dakota, 58103, United States

Location

Cara Therapeutics Study Site

Boardman, Ohio, 44512, United States

Location

Cara Therapeutics Study Site

Mason, Ohio, 45040, United States

Location

Cara Therapeutics Study Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Cara Therapeutics Study Site

Charleston, South Carolina, 29425, United States

Location

Cara Therapeutics Study Site

Thompson's Station, Tennessee, 37179, United States

Location

Cara Therapeutics Study Site

Dallas, Texas, 75230, United States

Location

Cara Therapeutics Study Site

Houston, Texas, 77056, United States

Location

Cara Therapeutics Study Site

Pflugerville, Texas, 78660, United States

Location

Cara Therapeutics Study Site

San Antonio, Texas, 78213, United States

Location

Cara Therapeutics Study Site

Webster, Texas, 77598, United States

Location

Cara Therapeutics Study Site

Spokane, Washington, 99202, United States

Location

Cara Therapeutics Study Site

Oakville, Ontario, Canada

Location

Cara Therapeutics Study Site

Peterborough, Ontario, Canada

Location

Cara Therapeutics Study Site

Richmond Hill, Ontario, Canada

Location

Cara Therapeutics Study Site

Toronto, Ontario, Canada

Location

Cara Therapeutics Study Site

Sherbrooke, Quebec, Canada

Location

Cara Therapeutics Study Site

Montreal, Canada

Location

Cara Therapeutics Study Site

Oshawa, Canada

Location

Cara Therapeutics Study Site

Québec, Canada

Location

Cara Therapeutics Study Site

Bad Bentheim, Germany

Location

Cara Therapeutics Study Site

Berlin, Germany

Location

Cara Therapeutics Study Site

Heidelberg, Germany

Location

Cara Therapeutics Study Site 2

Langenau, Germany

Location

Cara Therapeutics Study Site

Langenau, Germany

Location

Cara Therapeutics Study Site 2

Katowice, Poland

Location

Cara Therapeutics Study Site

Katowice, Poland

Location

Cara Therapeutics Study Site

Sosnowiec, Poland

Location

Cara Therapeutics Study Site

Szczecin, Poland

Location

Cara Therapeutics Study Site

Wroclaw, Poland

Location

Cara Therapeutics Study Site

Bilbao, Spain

Location

Cara Therapeutics Study Site

Madrid, Spain

Location

MeSH Terms

Conditions

Pruritus

Interventions

difelikefalin

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cara Therapeutics

  Cara Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A includes 4 arms and Part B includes 2 arms.

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 7, 2023
• Study Start: August 1, 2023
• Primary Completion: April 22, 2024
• Study Completion: May 7, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8); ES (2); DE (5); US (38); PL (5)