| Trial ID: | L0582 |
| Source ID: | NCT05482698
|
| Associated Drug: |
Mc2-25 Cream
|
| Title: |
The MC2-25 Cream in Subjects wITh CHronic KIdNEy Disease-aSsociated prurituS (ITCHINESS) Trial
|
| Acronym: |
ITCHINESS
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT05482698/results
|
| Conditions: |
Chronic Kidney Disease-associated Pruritus
|
| Interventions: |
DRUG: MC2-25 cream|DRUG: MC2-25 vehicle
|
| Outcome Measures: |
Primary: 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 |
|
| Sponsor/Collaborators: |
Sponsor: MC2 Therapeutics
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
111
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-07-01
|
| Completion Date: |
2024-02-02
|
| Results First Posted: |
2025-03-17
|
| Last Update Posted: |
2025-03-17
|
| Locations: |
The Royal London Hospital, London, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT05482698
|
