The study MC2-25 cream in subjects wITh CHronic KIdNEy Disease-aSsociated prurituS

MC2 Therapeutics is starting a new clinical trial of The MC2-25 Cream in Subjects wITh CHronic KIdNEy Disease-aSsociated prurituS (ITCHINESS) Trial.

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).

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.

The clinical trial started in July 1, 2022 and will continue throughout December 31, 2023.

Mean change in weekly mean Worst Itch Numeric Rating Score (WI-NRS) will be primary outcome measure. Mean change in weekly 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.

For more details: https://ichgcp.net/clinical-trials-registry/NCT05482698