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Monoclonal Antibodies

Dupilumab for Chronic Itch

Pflugerville, TX
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
* at least 1 severe lesion (IGA score = 4).
* 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.
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

See full description
Who is the study for?
This trial is for adults with Lichen Simplex Chronicus (LSC) who've had it for at least 6 months, have severe skin lesions, and experience chronic itching. Participants must have tried and failed a course of topical treatments or be unable to use them. They should also practice appropriate contraception.Check my eligibility
What is being tested?
The study compares the effects of Dupilumab injections versus placebo on reducing itchiness in LSC patients over a period of up to 24 weeks, followed by a 12-week observation phase. The participants will visit the clinic six times throughout the study.See study design
What are the potential side effects?
Potential side effects include local itching at the injection site and other reactions commonly associated with Dupilumab such as inflammation, redness or swelling around the injection area.

Eligibility Criteria

Inclusion Criteria

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

Closest Location:Austin Institute for Clinical Research - Pflugerville- Site Number : 8400203· Pflugerville, TX

Who is running the clinical trial?

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