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

Cara Therapeutics

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Notalgia Paresthetica; Pruritus

Treatments: Drug: difelikefalin 1.0 mg tablets; Drug: Placebo tablets; Drug: difelikefalin 0.25 mg tablets; Drug: difelikefalin 2.0 mg tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT05978063

CR845-310601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 214 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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214 participants in 4 patient groups, including a placebo group

Difelikefalin 2.0 mg tablets

Active Comparator group

Description:

Oral difelikefalin 2.0 mg tablet administered twice daily

Treatment:

Drug: difelikefalin 2.0 mg tablets

Difelikefalin 1.0 mg tablets

Active Comparator group

Description:

Oral difelikefalin 1.0 mg tablet administered twice daily

Treatment:

Drug: difelikefalin 1.0 mg tablets

Difelikefalin 0.25 mg tablets

Active Comparator group

Description:

Oral difelikefalin 0.25 mg tablet administered twice daily

Treatment:

Drug: difelikefalin 0.25 mg tablets

Placebo tablets

Placebo Comparator group

Description:

Oral placebo tablet administered twice daily

Treatment:

Drug: Placebo tablets