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Monoclonal Antibodies

Nemolizumab for Itching in Chronic Kidney Disease (NemoCKDaP Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Galderma R&D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has end-stage renal disease (ESRD) and have been on hemodialysis three times per week for at least three months prior to the start of screening.
Hemodialysis participants meeting the Kidney Outcome Quality Initiative Guidelines of hemodialysis adequacy within 60 days of screening, two single-pools of: -Kt/V at least 1.2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12
Awards & highlights

NemoCKDaP Trial Summary

This trial will test if nemolizumab is better than placebo at reducing itchiness in adults with kidney disease who are on dialysis.

Who is the study for?
Adults on hemodialysis for chronic kidney disease with moderate to severe itching (pruritus) lasting over three months can join. They must have a stable dialysis routine, no recent infections or hospitalizations for asthma, and not be pregnant or breastfeeding. Women able to have children must agree to use contraception or practice abstinence.Check my eligibility
What is being tested?
The trial is testing Nemolizumab against a placebo in reducing itchiness over 12 weeks in adults undergoing hemodialysis. Participants will randomly receive either the study drug or a placebo without knowing which one they are getting.See study design
What are the potential side effects?
Potential side effects of Nemolizumab may include reactions at the injection site, increased risk of infections due to immune system changes, and possible allergic responses among those sensitive to immunoglobulin products.

NemoCKDaP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe kidney disease and have been on dialysis 3 times a week for 3 months.
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My kidney dialysis is working well, meeting specific health standards.
Select...
I have had itching for 3 months or more, with no cause found other than kidney disease.
Select...
My pain level has been 5 or more out of 10 for the past week.
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I agree to not become pregnant or use birth control during and for 12 weeks after the study.
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I am using a reliable birth control method or my partner is sterile.
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I cannot have children due to menopause or surgery.

NemoCKDaP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Responders with an Improvement of Worst Itch Numeric Rating Scale (WI NRS) greater than and equal to (>=) 4 of from Baseline at Week 12
Secondary outcome measures
Proportion of Participants with an Improvement of >=3 from Baseline in Worst Itch Numeric Rating Scale (WI NRS) at Week 12
Proportion of Participants with an Improvement of >=3 from Baseline in Worst Itch Numeric Rating Scale (WI NRS) at Week 4
Proportion of Participants with an Improvement of >=4 from Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 12
+2 more
Other outcome measures
Percentage of Participants with an Improvement of >=3 from Baseline in Worst Itch Numeric Rating Scale (WI NRS) at Week 4
Percentage of Participants with an Improvement of >=4 from Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 12
Percentage of Participants with an Improvement of >=4 from Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 4
+1 more

Side effects data

From 2018 Phase 2 trial • 226 Patients • NCT03100344
28%
Dermatitis atopic
23%
Nasopharyngitis
18%
Asthma
9%
Headache
7%
Upper respiratory tract infection
7%
Gastroenteritis
5%
Oral herpes
5%
Pyrexia
4%
Back pain
4%
Cough
2%
Diarrhoea
2%
Urinary tract infection
2%
Blood creatine phosphokinase increased
2%
Rhinitis
2%
Nausea
2%
Septic shock
2%
Sinusitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nemolizumab (90 mg)
Nemolizumab (10 mg)
Nemolizumab (30 mg)
Placebo

NemoCKDaP Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Nemolizumab 60 mgExperimental Treatment1 Intervention
Group II: Nemolizumab 30 mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nemolizumab
2021
Completed Phase 3
~2500

Find a Location

Who is running the clinical trial?

Galderma R&DLead Sponsor
295 Previous Clinical Trials
59,960 Total Patients Enrolled

Media Library

Nemolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05075408 — Phase 2 & 3
Chronic Kidney Disease Research Study Groups: Nemolizumab 30 mg, Nemolizumab 60 mg, Placebo
Chronic Kidney Disease Clinical Trial 2023: Nemolizumab Highlights & Side Effects. Trial Name: NCT05075408 — Phase 2 & 3
Nemolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05075408 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many distinct sites is this clinical trial being conducted?

"Currently, this clinical trial is open to patients at Galderma Investigational Site 7038 in Fresh Meadows, New york, Galderma Investigational Site 7039 in Arlington, Texas, Galderma Investigational Site 7035 in Kansas City, Missouri, and 49 other locations."

Answered by AI

What are the proposed benefits of this clinical trial?

"The objectives of this study are to assess the proportion of participants with an improvement in worst itch numeric rating scale (WI NRS) at week 12, and the secondary objectives include the proportion of participants with an improvement in sleep disturbance numeric rating scale (SD NRS) at week 4, the percentage of participants with an improvement in worst itch numeric rating scale (WI NRS) at week 12, and the proportion of participants with an improvement in worst itch numeric rating scale (WI NRS) at week 12."

Answered by AI

How many study subjects are trialing this medication?

"252 participants that meet the eligibility requirements are necessary to run the study. The sponsor, Galderma R&D, will administer the trial from locations such as Galderma Investigational Site 7038 in Fresh Meadows, New york and Galderma Investigational Site 7039 in Arlington, Texas."

Answered by AI

Could you provide more information on Nemolizumab's efficacy?

"There are currently 10 ongoing clinical trials for the efficacy of Nemolizumab. Of these, 7 are in Phase 3. The majority of these studies are taking place in Regensburg, Missouri, but there are 1161 locations total running these trials."

Answered by AI

Could you please share whether this research project is still recruiting participants?

"Yes, this trial is still open and looking for patients. The original posting date was December 29th 2021, with the most recent edit on October 10th, 2022. They are recruiting 252 patients from 49 sites."

Answered by AI

Will this be the first time this type of trial has been conducted?

"Nemolizumab has been under clinical investigation since 2019 when Galderma R&D first sponsored a study. Phase 3 clinical trials are only conducted once a drug has received initial approval from an earlier trial, of which there have been 750 in the case of Nemolizumab. Currently, there are 10 live trials being conducted in 237 cities and 25 countries."

Answered by AI
~78 spots leftby Mar 2025