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NCT05075408 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Galderma R&D.

Completed
Registry status
Phase 2
Development phase
258
Enrollment target

NCT05075408: Completed Phase 2 study, sponsored by Galderma R&D.

NCT05075408 is a Phase 2 study that has completed, run by Galderma R&D. The registered enrollment target is 258 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05075408, a Phase 2 study, has completed, sponsored by Galderma R&D.

COMPLETED
Registry status
Phase 2
Development phase
258 participants
Enrollment target

Study 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.

Primary Outcome

Responders are defined as participants with an improvement of \>= 4 in WI NRS from baseline at Week 12 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or Adverse event(AE)/death related to study drug. The WI NRS is a scale that is used by responders to report intensity of their worst pruritus (itch) during last 24 hours. Participants were asked following question: For worst itch intensity:"On a scale of 0 to 10, with 0 being 'no itch' and 10 being th

Interventions

  • DRUG Placebo
  • DRUG Nemolizumab

Trial Details

FieldValue
Enrollment Target 258 participants
Start Date 2022-03-18
Est. Completion 2024-01-04
Phase Phase 2
Galderma R&D

158 total trials

What the finished NCT05075408 record still lists

NCT05075408 is an interventional study that assigns participants to a tested intervention. The registered 258 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT05075408 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05075408 about?

NCT05075408 is a clinical study titled "To Evaluate the Efficacy and Safety of Nemolizumab for 12 Weeks in Participants With Chronic Kidney Disease With Associated Moderate to Severe Pruritus". 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.

What is the current status of trial NCT05075408?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 258 participants. The study started on 2022-03-18. Estimated completion is 2024-01-04.

What interventions are being tested in trial NCT05075408?

The interventions under investigation include: Placebo (DRUG), Nemolizumab (DRUG).

Who is sponsoring clinical trial NCT05075408?

This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05075408's enrollment target sits among peer trials

258 212th of 2000 higher than 1,787 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05075408, the US trial registry maintained by the National Library of Medicine. NCT05075408 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.