Nemolizumab for Pruritus

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Pruritus+4 More
Nemolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Pruritus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Baseline, Week 12

Baseline, Week 12
Percentage of Participants with an Improvement of >=3 from Baseline in Worst Itch Numeric Rating Scale (WI NRS) at Week 12
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 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 12
Proportion of Participants with an Improvement of >=4 from Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 12
Proportion of Participants with an Improvement of >=4 from Baseline in Worst Itch Numeric Rating Scale (WI NRS) at Week 12
Baseline, Week 4
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 4
Percentage of Participants with an Improvement of >=4 from Baseline in Worst Itch Numeric Rating Scale (WI NRS) at Week 4
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 4
Proportion of Participants with an Improvement of >=4 from Baseline in Worst Itch Numeric Rating Scale (WI NRS) at Week 4

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

Side Effects for

Nemolizumab (30 mg)
25%Nasopharyngitis
23%Dermatitis atopic
12%Asthma
11%Upper respiratory tract infection
7%Headache
5%Sinusitis
5%Gastroenteritis
5%Folliculitis
5%Dry skin
5%Rhinitis
5%Arthralgia
5%Cough
5%Back pain
5%Abdominal pain
5%Diarrhoea
2%Oral herpes
2%Urinary tract infection
2%Blood creatine phosphokinase increased
2%Pyrexia
2%Cellulitis
2%Nausea
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT03100344) in the Nemolizumab (30 mg) ARM group. Side effects include: Nasopharyngitis with 25%, Dermatitis atopic with 23%, Asthma with 12%, Upper respiratory tract infection with 11%, Headache with 7%.

Trial Design

3 Treatment Groups

Nemolizumab 30 mg
1 of 3
Nemolizumab 60 mg
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

252 Total Participants · 3 Treatment Groups

Primary Treatment: Nemolizumab · Has Placebo Group · Phase 2 & 3

Nemolizumab 30 mg
Drug
Experimental Group · 1 Intervention: Nemolizumab · Intervention Types: Drug
Nemolizumab 60 mg
Drug
Experimental Group · 1 Intervention: Nemolizumab · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nemolizumab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 12

Who is running the clinical trial?

Galderma R&DLead Sponsor
286 Previous Clinical Trials
58,735 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have 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.
You have pruritus for at least three months (other than a physician's letter/statement or a written conversation of site investigators).
Use an intrauterine device or intrauterine hormone releasing system.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: November 4th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.