Status:
COMPLETED
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)
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Moderate to Severe Atopic Hand and Foot Dermatitis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The primary objective of the study is to assess the efficacy of dupilumab on skin lesions in patients with atopic hand and foot dermatitis. The secondary objectives of the study are: * To assess the...
Eligibility Criteria
Inclusion
- Key
- 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
- Patients with documented recent history (within 6 months before the screening visit) of inadequate response of atopic hand and foot dermatitis to topical medication(s)
- Patients meet the diagnosis criteria for atopic dermatitis (AD)
- Provide informed consent/assent signed by study patient or legally acceptable representative
- Patients need to have been compliant with the skin protection measures through the entire duration of the screening period
- Key
Exclusion
- Treatment with dupilumab in the past
- Patients with a positive patch test reaction that are deemed to be clinically relevant as the current cause of the hand and foot dermatitis
- Patients with documented exposure to irritants believed to be a predominant cause of the current hand and foot dermatitis
- Treatment with systemic corticosteroids or non-steroidal immunosuppressive drugs within 4 weeks prior to baseline
- Known history of HIV/HBV/HCV infection
- Pregnant or breastfeeding women or planning to become pregnant or breastfeed during the patient's participation in this study
- Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment and during the study
- NOTE: Other protocol defined inclusion / exclusion criteria apply
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2022
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT04417894
Start Date
April 14 2021
End Date
November 23 2022
Last Update
December 22 2023
Active Locations (48)
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1
Regeneron Study Site
Birmingham, Alabama, United States, 35209
2
Regeneron Study Site
Redwood City, California, United States, 94063
3
Regeneron Study Site
Washington D.C., District of Columbia, United States, 20037
4
Regeneron Study Site
Macon, Georgia, United States, 31217