NCT05075408

To Evaluate the Efficacy and Safety of Nemolizumab for 12 Weeks in Participants With Chronic Kidney Disease With Associated Moderate to Severe Pruritus

A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Nemolizumab in Subjects With Chronic Kidney Disease With Associated Moderate to Severe Pruritus

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the efficacy of nemolizumab compared to placebo at reducing the intensity of pruritus after a 12-week treatment period in adult hemodialysis participants with moderate to severe pruritus.

Conditions

• Chronic Kidney Disease Associated Moderate to Severe Pruritus

Interventions

Type	Name	Description
DRUG	Nemolizumab	Participants received a loading dose of 60 mg nemolizumab at Baseline followed by 2 Subcutaneous (SC) injections for a total dose of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
DRUG	Nemolizumab	Participants received 2 SC injections of 30 mg nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.
DRUG	Placebo	Participants received 2 SC injections of 30 mg placebo-matched to nemolizumab once every 4 weeks i.e. at Week 4 and Week 8.

Timeline

• Start date: 2021-12-29
• Primary completion: 2024-01-04
• Completion: 2024-01-04
• First posted: 2021-10-12
• Last updated: 2025-02-20
• Results posted: 2025-02-20

Locations

64 sites across 4 countries: United States, Hungary, Poland, Spain

Regulatory

• FDA-regulated drug study