The MC2-25 Cream in Subjects wITh CHronic KIdNEy Disease-aSsociated prurituS (ITCHINESS) Trial (ITCHINESS)

A Parallel-group (2-Arm), Randomized, Double-blind, 12-week Trial to Evaluate the Efficacy and Safety of MC2-25 Cream and MC2-25 Vehicle in Subjects With Chronic Kidney Disease-associated Pruritus (CKD-aP)

The purpose of this study is to access the efficacy and safety of MC2-25 cream and MC2-25 vehicle for treatment of chronic kidney disease associated pruritus (CKD)-aP).

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease-associated Pruritus
• Intervention / Treatment: Drug: MC2-25 cream; Drug: MC2-25 vehicle

Detailed Description

In this trial, subjects who fulfil all inclusion and exclusion criteria are enrolled.

Eligible subjects will be randomised in a 2:1 ratio to MC2-25 cream or MC2-25 vehicle, respectively.

The subjects will apply the assigned investigational medicinal product (IMP) twice daily for 12 weeks.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • The Royal London Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult males or non-pregnant females of any race or ethnicity who are ≥ 18 years of age at the time of screening
• Has provided written informed consent
• Chronic (>3 months) kidney disease (CKD) stages G3-G5 (i.e., estimated glomerular filtration rate [eGFR] by CKD-EPI creatinine 2021 equation <60 mL/min/1.73 m2)

• Specifically for CKD subjects on haemodialysis (HD) or haemodiafiltration (HDF):

  1. Subjects must be established on HD or HDF 3 times per week continuously for at least 3 months prior to the start of screening and must not have plans to change from HD to HDF or vice versa during the trial
  2. Subjects who require an occasional additional HD or HDF treatment to manage fluid overload may be enrolled as long as it is anticipated that no more than 4 such treatments will be required in any given month
• At least moderate CKD-aP defined as WI-NRS ≥4
• Female subjects must be of either: a. Non-childbearing potential or b. Childbearing potential

Exclusion Criteria:

• Has a functioning kidney transplant or is scheduled to receive a kidney transplant during the trial (Note: subject can be on waiting list for kidney transplant)
• Subjects who receive peritoneal dialysis
• In the opinion of the investigator has pruritus attributed to a cause other than CKD or its complications
• Has localized itch restricted to the palms of the hands
• Has concurrent skin conditions (including but not limited to pruritic dermatoses, active skin infections, ulcerations) that may limit or prevent application of MC2-25 cream or MC2-25 vehicle or that may interfere with evaluation of the effects of MC2-25 cream or MC2-25 vehicle on the skin at the Screening or Baseline visits
• Subjects who will have skin biopsies performed must not have any known hypersensitivity to the local anaesthetic or diagnosed bleeding disorders
• Has a concurrent or recent (within 12 months prior to screening) medical condition that, in the opinion of the investigator, could pose undue risk to the subject, impede completion of the trial procedures, or would compromise the validity of the trial measurements
• Has a known current generalized infection (bacterial, viral, or fungal)
• Start of a new or change to existing systemic treatment for CKD-aP
• Use of emollients on CKD-aP areas within 10 days prior to the Baseline visit
• Use of any topical treatment on CKD-aP areas
• Use of any light therapy for CKD-aP
• Use of non-biologic systemic immunosuppressive treatment
• Use of biologic systemic treatment
• Subjects not currently on dialysis but who are likely to initiate routine dialysis during participation in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MC2-25 cream; MC2-25 cream Twice daily applications for 12 weeks	Drug: MC2-25 cream; Topical application
Placebo Comparator: MC2-25 vehicle; MC2-25 vehicle Twice daily applications for 12 weeks	Drug: MC2-25 vehicle; Topical application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Weekly Mean Worst Itch Numeric Rating Score (WI-NRS)	Mean change in WI-NRS score, calculated as the average of weekly means WI-NRS values from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle. Weekly mean WI-NRS is calculated as the average of all and at least 4 non-missing WI-NRS values recorded in the subjects' diaries for the 7 days prior to and including the scheduled in clinic visits (8 days in total expected). The WI-NRS was scored on a 11-point numeric rating scale ranging from 0 to 10, where 0=no itch and 10=worst imaginable itch.	12 weeks

Collaborators and Investigators

• Sponsor: MC2 Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): February 2, 2024
• Study Completion (Actual): February 2, 2024

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Skin Manifestations; Skin Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Pruritus
• Other Study ID Numbers: MC2-25-C1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No