Nemolizumab for Pruritus
Phase-Based Progress Estimates
Effectiveness
Safety
Pruritus+4 More
Nemolizumab - DrugEligibility
18+
All Sexes
What conditions do you have?
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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
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
This is further along than 68% of 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
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: DrugNemolizumab 60 mg
Drug
Experimental Group · 1 Intervention: Nemolizumab · Intervention Types: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
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 - 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.
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