NCT05482698

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: MC2 Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

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.

Conditions

• Chronic Kidney Disease-associated Pruritus

Interventions

Type	Name	Description
DRUG	MC2-25 cream	Topical application
DRUG	MC2-25 vehicle	Topical application

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-02-02
• Completion: 2024-02-02
• First posted: 2022-08-01
• Last updated: 2025-03-17
• Results posted: 2025-03-17

Locations

1 site across 1 country: United Kingdom