This is a clinical trial (study), to be conducted in several clinical sites worldwide, of an oral study drug which will be investigated in adult patients with moderate to severe pruritus (itching) associated with Notalgia Paresthetica to assess if it's effective and safe.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Cara Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

4 Dec 2023 → 13 Jun 2024

Decision date (initial)

2023-10-10

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Cara Therapeutics, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Part A: To evaluate three different doses of oral difelikefalin compared to placebo and select one dose for further investigation.
Part B: To evaluate the efficacy of the selected dose of oral difelikefalin in reducing the intensity of itch after 8 weeks of treatment.

Secondary objectives 4

1. Part A: To assess if and what adverse events occur after discontinuation of three different doses of oral difelikefalin after completing 8 weeks of the treatment period.
2. Part B: 1) To evaluate the efficacy of oral difelikefalin in reducing the intensity of itch in different time points.
3. Part B: 2) To evaluate the efficacy of oral difelikefalin in reducing the intensity of burning sensation, skin tingling and the effect on skin hyperpigmentation (discoloration).
4. Part B: 3) To evaluate the safety and tolerability of oral difelikefalin in a larger number of patients.

Conditions and MedDRA coding

Moderate-to-Severe pruritus in adult subjects with notalgia paresthetica

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. To be eligible for inclusion into the study, a patient must meet the following criteria: Has moderate to severe pruritus;
2. Has at least a 6-month history of chronic pruritus due to NP;
3. Presence of hyper- or hypopigmented macules, hyperkeratosis, lichenification, and/or excoriation in the middle to upper back in the vicinity of the scapula;
4. Has NP-related pruritus that is considered appropriate for systemic therapy;
5. Female subject is not pregnant or nursing during any period of the study.

Exclusion criteria 3

1. 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 NP;
2. Has a history of skin disease or presence of skin condition other than those related to NP that, in the opinion of the Investigator, would interfere with the study assessments;
3. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. The percentage of patients achieving ≥4-point improvement from baseline in the weekly mean of the daily 24-hour Itch scores assessed on Day 2, at Week 1, 2, 4 and 8.
2. The percentage of patients who are free or almost free of itch by achieving a weekly mean of the daily 24-hour Itch score of 0 to 1, inclusive at Week 8 (complete responder).
3. Mean change from baseline in the burning sensation scale at Week 8.
4. Mean change from baseline in the skin tingling scale at Week 8.
5. The percentage of patients with hyperpigmentation assessed as clear (0) or almost clear (1) at Week 8.

Secondary endpoints 2

1. Number of adverse events that started after the end of treatment period based on daily assessment during the 2-week treatment discontinuation period.
2. Safety evaluations, including number of adverse events during the study.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Cara Therapeutics Inc.

Sponsor organisation

Cara Therapeutics Inc.

Address

107 Elm Street Fl 9

City

Stamford

Postcode

06902-3834

Country

United States

Scientific contact point

Organisation

Cara Therapeutics Inc.

Contact name

Clinical Trials

Public contact point

Organisation

Cara Therapeutics Inc.

Contact name

Clinical Trials

Third parties 11

Locations

3 EU/EEA countries · 20 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Application history

5 submissions — initial application plus substantial / non-substantial modifications