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Monoclonal Antibodies

Nemolizumab 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 baseline up to week 24
Awards & highlights
Pivotal Trial

Summary

This trial is to see if a drug called nemolizumab is still effective in treating prurigo nodularis after participants stop taking it. It will also look at the safety of the drug.

Eligible Conditions
  • Prurigo Nodularis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time From Baseline to Relapse Meeting At Least 1 of the Defined Criteria
Secondary study objectives
Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit
Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit

Side effects data

From 2022 Phase 3 trial • 274 Patients • NCT04501679
7%
Headache
5%
Dermatitis atopic
4%
Neurodermatitis
1%
Pemphigoid
1%
Dermatitis contact
1%
Pneumonia
1%
Supraventricular tachycardia
1%
Pneumococcal sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Nemolizumab

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
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nemolizumab
2022
Completed Phase 3
~2750

Find a Location

Who is running the clinical trial?

Galderma R&DLead Sponsor
302 Previous Clinical Trials
60,653 Total Patients Enrolled
4 Trials studying Prurigo Nodularis
1,130 Patients Enrolled for Prurigo Nodularis

Media Library

Nemolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05052983 — Phase 3
Prurigo Nodularis Research Study Groups: Nemolizumab, Placebo
Prurigo Nodularis Clinical Trial 2023: Nemolizumab Highlights & Side Effects. Trial Name: NCT05052983 — Phase 3
Nemolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05052983 — Phase 3
~9 spots leftby Nov 2025
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