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Monoclonal Antibodies

Dupilumab for Prurigo Nodularis

Phase 3
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be ≥6 months to <18 years of age, at the time of signing the informed consent
Participants must have an average worst itch score of ≥7 in the 7 days prior to Day 1
Must not have
Planned or anticipated major surgical procedure during the participant's participation in this clinical trial
Participants who have taken biologic therapy/systemic immunosuppressant/immunomodulator within 4 weeks before the screening visit or 5 half-lives, whichever is longer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to week 40
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is a Phase 3 study that will look at how the body processes a drug and its safety. It will involve multiple medical centers and will be open-label. Participants will go through three periods

Who is the study for?
This clinical trial is for children and teenagers from 6 months to under 18 years old with Prurigo Nodularis, a skin condition causing itchy lumps. They must have been diagnosed at least 3 months prior, have an itch intensity score of ≥7, and lesions on multiple body areas. Participants need to be able to use an e-Diary daily.
What is being tested?
The study tests Dupilumab's effects on young patients with Prurigo Nodularis over approximately one year. It includes a screening period, a treatment phase lasting six months where the drug is given, followed by four months of observation without treatment.
What are the potential side effects?
Dupilumab may cause side effects such as injection site reactions (redness or swelling), eye irritation or inflammation, cold sores in your mouth or throat area, and allergic reactions that can include rash or hives.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 6 months and 18 years old.
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My worst itch score has been 7 or more in the past week.
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I have been diagnosed with prurigo nodularis for over 3 months, with at least 6 itchy bumps on more than one area of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am expecting to undergo a major surgery during the trial.
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I haven't taken any immune system affecting drugs in the last 4 weeks or 5 half-lives, whichever is longer.
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I have previously participated in a dupilumab study or used it.
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I have severe skin conditions like eczema that could affect skin disease diagnosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to week 40
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to week 40 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Concentration of dupilumab in serum

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367
9%
Conjunctivitis
7%
Headache
3%
Dermatitis Atopic
2%
Nasopharyngitis
1%
Accidental Overdose
1%
Drug Hypersensitivity
1%
Polyarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Placebo/Dupilumab
OLE Period: Dupilumab/Dupilumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DupilumabExperimental Treatment1 Intervention
Administered subcutaneously (SC) based on weight and age
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~11960

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,201 Previous Clinical Trials
4,036,408 Total Patients Enrolled
2 Trials studying Prurigo Nodularis
450 Patients Enrolled for Prurigo Nodularis
Regeneron PharmaceuticalsIndustry Sponsor
665 Previous Clinical Trials
385,723 Total Patients Enrolled
1 Trials studying Prurigo Nodularis
300 Patients Enrolled for Prurigo Nodularis
~12 spots leftby Oct 2027
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