A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Mo… (NCT04417894) | Clinical Trial Compass
CompletedPhase 3
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)
United States, Germany, Japan133 participantsStarted 2021-04-14
Plain-language 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 efficacy of dupilumab on various other domains (pruritus, pain, sleep loss, health related QoL, work life impairment) in patients with atopic hand and foot dermatitis
* To evaluate the safety and tolerability of dupilumab administered to patients with atopic hand and foot dermatitis
* To evaluate systemic exposure and immunogenicity of dupilumab in patients with atopic hand and foot dermatitis
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* 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 Criteria:
* 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 d…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16