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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
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500044-38-01
Acronym
MC2-25-C1 /ITCHINESS
Enrollment
48
Registered
2023-01-16
Start date
2023-02-20
Completion date
2024-02-02
Last updated
2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease associated Pruritus

Brief summary

Mean change in weakly mean WI-NRS recorded in the subject’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle.

Detailed description

Percentage of subjects obtaining a ≥4-point improvement in weekly mean WI-NRS recorded in the subject’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle., Percentage of subjects obtaining a ≥3-point improvement in weekly mean WI-NRS recorded in the subject’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle., Percentage of subjects obtaining a complete response in weekly mean WI-NRS recorded in the subject’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle.

Interventions

Sponsors

Mc2 Therapeutics Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Mean change in weakly mean WI-NRS recorded in the subject’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle.

Secondary

MeasureTime frame
Percentage of subjects obtaining a ≥4-point improvement in weekly mean WI-NRS recorded in the subject’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle., Percentage of subjects obtaining a ≥3-point improvement in weekly mean WI-NRS recorded in the subject’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle., Percentage of subjects obtaining a complete response in weekly mean WI-NRS recorded in the subject’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle.

Countries

Germany, Hungary, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026