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

NCT05075408 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2026-05-01

Study results available
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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

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.

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-18
Primary Completion
2024-01-04
Completion
2024-01-04
FDA Drug
Yes

Countries

  • United States
  • Hungary
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05075408 on ClinicalTrials.gov