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Monoclonal Antibodies

dupilumab for Atopic Hand and Foot Dermatitis

Phase 3
Waitlist Available
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with involvement of at least 2 anatomical areas at screening and baseline
Patients need to have an IGA hand and foot score of 3 or 4 (moderate-to-severe disease) at screening and baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 28
Awards & highlights

Study Summary

This trial is testing if dupilumab is an effective treatment for atopic hand and foot dermatitis, as well as evaluating its safety and side effects.

Eligible Conditions
  • Atopic Hand and Foot Dermatitis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16
Secondary outcome measures
Change From Baseline to Week 16 in Percent Surface Area of Hand and Foot Involvement With Atopic Dermatitis (AD)
Change From Baseline to Week 16 in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)
Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS
+16 more

Side effects data

From 2022 Phase 3 trial • 133 Patients • NCT04417894
24%
Nasopharyngitis
16%
COVID-19
10%
Upper respiratory tract infection
9%
Dermatitis atopic
6%
Blood creatine phosphokinase increased
1%
Post procedural infection
1%
Adenocarcinoma of colon
1%
Metastases to lung
1%
Syncope
1%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Matching Placebo
Dupilumab Q2W

Trial Design

2Treatment groups
Experimental Treatment
Group I: dupilumabExperimental Treatment1 Intervention
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
Group II: Matching PlaceboExperimental Treatment1 Intervention
Administered SC Q2W, following a loading dose on Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dupilumab
2022
Completed Phase 4
~330
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
615 Previous Clinical Trials
379,701 Total Patients Enrolled
SanofiIndustry Sponsor
2,162 Previous Clinical Trials
3,511,940 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
259 Previous Clinical Trials
250,911 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any associated dangers with dupilumab?

"Dupilumab's safety is well supported by Phase 3 clinical trial data, and thus it received a score of 3."

Answered by AI

What is the precedent for dupilumab as a medication?

"dupilumab was first studied in 2015. There have been a total of 18296 completed studies, with 52 live clinical trials as of now. A large portion of these active studies are based in Houston, Texas."

Answered by AI

Does this investigation set a precedent for other future research?

"Since 2015, dupilumab has undergone extensive research with the first clinical trials sponsored by Sanofi. In 2015, 880 patients participated in the first study which led to dupilumab's approval in Phase 3 drug trials. Currently, dupilumab is being trialed in 52 active studies involving 455 cities and 43 countries."

Answered by AI

What are some of the conditions that dupilumab is most often used to treat?

"Dupilumab is not only an accepted therapy for atopic dermatitis, but can be used to treat other failures like corticosteroid therapy, eosinophil, and asthma."

Answered by AI

Are there any other research centers conducting this trial in America?

"Right now, this clinical trial is recruiting patients from 16 different locations, which include hospitals in Houston, Morgantown, and Winston-Salem, as well as other locations. If you enroll, try to select the site that is closest to you to limit travel."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis (Liberty-AD-HAFT)
2021. "A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis (Liberty-AD-HAFT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04417894.
~33 spots leftby Apr 2025
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