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

NCT05482698 | Completed Phase 2 Results

• 1 other identifier: MC2-25-C1
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Kidney Disease-associated Pruritus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

MC2-25 cream

EXPERIMENTAL

MC2-25 cream Twice daily applications for 12 weeks

Drug: MC2-25 cream

MC2-25 vehicle

PLACEBO COMPARATOR

MC2-25 vehicle Twice daily applications for 12 weeks

Drug: MC2-25 vehicle

Interventions

MC2-25 cream DRUG

Topical application

MC2-25 cream

MC2-25 vehicle DRUG

Topical application

MC2-25 vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MC2 Therapeutics: lead

Study Sites (1)

The Royal London Hospital

London, United Kingdom

Location

Results Point of Contact

• Title: Chief Medical Officer
• Organization: MC2 Therapeutics

info@mc2theraprutics.com

+45 2018 1111

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel-group, Randomized, Double-blind

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 1, 2022
• Study Start: July 1, 2022
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: March 17, 2025
• Results First Posted: March 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)