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Monoclonal Antibodies

Nemolizumab 30 mg for Prurigo Nodularis

Phase 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to end of treatment period (24 weeks)
Awards & highlights
Pivotal Trial

Summary

This trialwill test if a new drug can help people 18+ with prurigo nodularis after 16 weeks.

Eligible Conditions
  • Prurigo Nodularis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to end of treatment period (24 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to end of treatment period (24 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16
Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16
Secondary study objectives
Number of Participants With PP NRS < 2 at Week 16
Number of Participants With PP NRS < 2 at Week 4
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)
+3 more

Side effects data

From 2023 Phase 3 trial • 286 Patients • NCT04501666
8%
Neurodermatitis
7%
Headache
7%
COVID-19
6%
Nasopharyngitis
5%
Cough
5%
Eczema
3%
Dyspnoea
1%
Acarodermatitis
1%
Urinary tract infection
1%
Pemphigoid
1%
Squamous cell carcinoma of skin
1%
Depressed mood
1%
Acute myocardial infarction
1%
Tension headache
1%
Cholecystitis acute
1%
Coronary artery disease
1%
Campylobacter colitis
1%
Type 2 diabetes mellitus
1%
Basal cell carcinoma
1%
Osteoarthritis
1%
Cellulitis
1%
Subdural haemorrhage
1%
Arachnoid cyst
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nemolizumab
Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NemolizumabExperimental Treatment1 Intervention
Participants weighing less than (\<) 90 kilogram (kg) received two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once every 4 weeks (Q4W). Participants weighing greater than or equal to (\>=) 90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants weighing \< 90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>= 90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nemolizumab 30 mg
2020
Completed Phase 3
~290

Find a Location

Who is running the clinical trial?

Galderma R&DLead Sponsor
302 Previous Clinical Trials
60,401 Total Patients Enrolled
4 Trials studying Prurigo Nodularis
878 Patients Enrolled for Prurigo Nodularis
~55 spots leftby Dec 2025
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