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Monoclonal Antibodies

Dupilumab for Chronic Itch

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
* Participant must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent.
* at least 1 severe lesion (IGA score = 4).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights
Pivotal Trial

Summary

This trial aims to see if dupilumab injections can help reduce itching (pruritus) in adults with LSC compared to placebo injections. Participants will receive injections for up to 24 weeks

Who is the study for?
This trial is for adults with Lichen Simplex Chronicus (LSC) who have at least two lesions, one severe lesion, and a history of the condition for six months or more. Participants must have tried and failed a course of topical treatments within the last six months or be unable to use them. They should not be on systemic treatments other than antihistamines.
What is being tested?
The study compares Dupilumab injections against placebo in treating pruritus (itchiness) associated with LSC. It's a Phase 3 trial where participants will receive treatment for up to 24 weeks and then be followed up for another 12 weeks over six visits.
What are the potential side effects?
Dupilumab may cause side effects such as local itching at the injection site, general itchiness related to skin conditions like Atopic Dermatitis, and potentially other reactions that are common with injectable biologic medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am at least 18 years old or the legal age of consent where the study is conducted.
Select...
I have at least one severe skin lesion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24
Secondary study objectives
Change in DLQI total score from baseline to Week 24
Change in ItchyQoL score from baseline to Week 24
Change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24
+2 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367
12%
Accidental Overdose
2%
Conjunctivitis
2%
Nasopharyngitis
2%
Headache
2%
Dermatitis Atopic
1%
Fall
1%
Multiple Fractures
100%
80%
60%
40%
20%
0%
Study treatment Arm
OLE Period: Dupilumab/Dupilumab
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Placebo/Dupilumab

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: DupilumabExperimental Treatment1 Intervention
Dupilumab subcutaneous injection as per protocol
Group II: PlaceboPlacebo Group1 Intervention
Placebo subcutaneous injection as per protocol
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?

Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
385,688 Total Patients Enrolled
SanofiLead Sponsor
2,216 Previous Clinical Trials
4,047,496 Total Patients Enrolled
~91 spots leftby Apr 2027
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