Moderate to Severe Atopic Hand and Foot DermatitisPhase 3NCT04417894

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)

A Phase 3 study testing dupilumab in people with Moderate to Severe Atopic Hand and Foot Dermatitis, run by Regeneron Pharmaceuticals at 48 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Moderate to Severe Atopic Hand and Foot Dermatitis
What is being tested?: dupilumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 133 participants
Where: 48 sitesin 4 countries
Study dates: 14 Apr 2021to 23 Nov 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

48 sites in 4 countries.

Country

City, postcode or hospital

48 sites in 4 countries

United States17 sites

Regeneron Study Site
Birmingham, Alabama, 35209
Regeneron Study Site
Columbus, Indiana, 47201
Regeneron Study Site
Houston, Texas, 77004
Regeneron Study Site
Kew Gardens, New York, 11415
Regeneron Study Site
Macon, Georgia, 31217
Regeneron Study Site
Milwaukee, Wisconsin, 53226
Regeneron Study Site
Mineola, New York, 11501
Regeneron Study Site
Morgantown, West Virginia, 26505
Regeneron Study Site
Norfolk, Virginia, 23502
Regeneron Study Site
Portland, Oregon, 97239
Regeneron Study Site
Redwood City, California, 94063
Regeneron Study Site
Rockville, Maryland, 20850
Regeneron Study Site
Saint Joseph, Missouri, 64506
Regeneron Study Site
Sandy Springs, Georgia, 30328
Regeneron Study Site
St Louis, Missouri, 63104
Regeneron Study Site
Washington D.C., District of Columbia, 20037
Regeneron Study Site
Winston-Salem, North Carolina, 27157

Other trials in United States

Germany12 sites

Regeneron Study Site
Augsburg, 86179
Regeneron Study Site
Berlin, 10117
Regeneron Study Site
Berlin, 10789
Regeneron Study Site
Bonn, 53127
Regeneron Study Site
Dresden, 01307
Regeneron Study Site
Frankfurt am Main, Hesse, 60590
Regeneron Study Site
Gera, 07548
Regeneron Study Site
Kiel, 24105
Regeneron Study Site
Langenau, Baden-Wurttemberg, 89129
Regeneron Study Site
Lübeck, 23538
Regeneron Study Site
Mahlow, 15831
Regeneron Study Site
Münster, 48149

Other trials in Germany

Poland11 sites

Regeneron Study Site
Bialystok, 15-453
Regeneron Study Site
Chorzów, 41-516
Regeneron Study Site
Katowice, 40-648
Regeneron Study Site
Katowice, 40-851
Regeneron Study Site
Kielce, 25-155
Regeneron Study Site
Ostrowiec Świętokrzyski, 27-400
Regeneron Study Site
Warsaw, 01-142
Regeneron Study Site
Warsaw, 02-692
Regeneron Study Site
Warsaw, 02-953
Regeneron Study Site
Wroclaw, 50-381
Regeneron Study Site
Wroclaw, 51-318

Other trials in Poland

Japan8 sites

Regeneron Study Site
Kawasaki, Kanagawa, 211-0063
Regeneron Study Site
Kyoto, 602-8566
Regeneron Study Site
Osaka, 532-0003
Regeneron Study Site
Sakai, Osaka, 593-8324
Regeneron Study Site
Shinjuku, Tokyo, 169-0075
Regeneron Study Site
Tachikawa, Tokyo, 190-0023
Regeneron Study Site
Tokyo, 105-0012
Regeneron Study Site
Tokyo, 143-0023

Other trials in Japan

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis

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

Conditions: Moderate to Severe Atopic Hand and Foot Dermatitis
Being tested: dupilumab, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dupilumabDrug
Also called DUPIXENT®, REGN668, SAR231893
Solution for subcutaneous (SC) injection administration
PlaceboDrug
Solution for SC injection administration

Study groups in NCT04417894
Study group	Role	What they receive
dupilumab	Experimental	Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1 Receives: Drug: dupilumab
Matching Placebo	Experimental	Administered SC Q2W, following a loading dose on Day 1 Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16
IGA is an assessment scale used to determine severity of hand and foot AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Higher score is indicative of more severe disease.
Measured: At week 16

Secondary outcomes (19)

Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus Numerical Rating Scale (NRS) of ≥4 Points From Baseline to Week 16
Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
Measured: Baseline to week 16
Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥3 From Baseline to Week 16
Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
Measured: Baseline to week 16
Percent Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS
Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
Measured: Baseline to week 16
Percent Change in Modified Total Lesion Sign Score (mTLSS) for Hand/Foot Lesions From Baseline to Week 16
mTLSS combines an evaluation of hand and foot eczema lesions severity; scores are summed, extending from a base estimation of 0 (no signs or symptoms) to the most extreme of 18 (more serious disease).
Measured: Baseline to Week 16
Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS
Pain NRS Scale is an assessment tool used to report the intensity of a participant's pain. Participants will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain possible).
Measured: Baseline to week 16
Mean Change From Baseline to Week 16 in Weekly Average of Daily Sleep NRS
Sleep NRS is an 11-point scale (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep.
Measured: Baseline to week 16
Change From Baseline to Week 16 in Percent Surface Area of Hand and Foot Involvement With Atopic Dermatitis (AD)
Measured: Baseline to week 16
Percent Change From Baseline to Week 4 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS
Pruritus NRS is an assessment tool that is used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
Measured: Baseline to week 4
Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥4 From Baseline to Week 4
Pruritus NRS is an assessment tool that is used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
Measured: Baseline to week 4
Percent Change From Baseline to Week 16 in Hand Eczema Severity Index (HECSI) Score in Participants With Hand Dermatitis
For participants with hand dermatitis HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area). The range for the combined HECSI score is from 0 to 360 (5x6x3x4).
Measured: Baseline to week 16
Percentage of Participants With HECSI-75 at Week 16
HECSI-75 is defined as HECSI score has ≥75% improvement from baseline for participants with hand dermatitis.
Measured: At week 16
Percentage of Participants With HECSI-50 at Week 16
HECSI-50 is defined as HECSI score has ≥50% improvement from baseline, for participants with hand dermatitis.
Measured: At week 16
Percentage of Participants With HECSI-90 at Week 16
HECSI-90 is defined as HECSI score has ≥90% improvement from baseline for participants with hand dermatitis.
Measured: At week 16
Change From Baseline to Week 16 in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)
For participants with hand dermatitis, QOLHEQ is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in those suffering from hand eczema. QOLHEQ overall scoring ranges as follows: 0 (best score) to 117 (worst score).
Measured: Baseline to week 16
Mean Change From Baseline to Week 16 in Work Productivity and Impairment (WPAI) and Classroom Impairment Questionnaire (CIQ)
WPAI + CIQ is a self-administered instrument used to capture the impairment to work productivity/classroom impairment and activity due to atopic hand and foot dermatitis. The WPAI+CIQ yields 4 types of scores: absenteeism, presenteeism, work/classroom productivity loss and activity impairment. All scores range from 0 to 100% with 100% indicating total work/classroom productivity impairment and 0 no impairment at all.
Measured: Baseline to week 16
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 16
Measured: Through week 16
Trough Concentration of Functional Dupilumab in Serum at Various Time Points
Measured: Up to week 28
Number of Participants With Treatment-Emergent (TE) Anti-Drug Antibody (ADA)
Measured: Up to week 28
Number of Participants With Treatment-Emergent ADA by Maximum Titer Category
Measured: Up to Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Apr 202123 Nov 2022

First posted5 Jun 2020
Study start14 Apr 2021
Primary completion31 Aug 2022
Study completion23 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Moderate to Severe Atopic Hand and Foot DermatitisStudies of the same condition, open and under way.
More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04417894
Sponsor's protocol ID: R668-AD-1924
Other IDs: 2019-003088-22, 2019
Status last verified: Dec 2023
First submitted: 2 Jun 2020
Last updated: 22 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Publications

Armstrong A, Kircik L, Metelitsa A, Warren RB, Rodriguez A, Volc S, Issa N, Chovatiya R, von Eyben R, Festini T, Johansen P, Ehst B. Tralokinumab Versus Dupilumab for the Treatment of Atopic Dermatitis with Moderate-to-Severe Hand Involvement: A Matching-Adjusted Indirect Comparison. Dermatol Ther (Heidelb). 2026 Oct 2. doi: 10.1007/s13555-026-01922-8. Online ahead of print.
PubMed 42825999
Cohen D, Bewley A, Wollenberg A, Hong HC, Armstrong A, Jonsen E, Maslin D, Thoning H, von Eyben R, Chovatiya R. Matching-Adjusted Indirect Comparison of the Efficacy of Delgocitinib Cream and Dupilumab in the Treatment of Moderate to Severe Atopic Hand Eczema. Dermatol Ther (Heidelb). 2026 Jan;16(1):423-436. doi: 10.1007/s13555-025-01592-y. Epub 2025 Nov 15.
PubMed 41240207

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis
ClinicalTrials.gov ID: NCT04417894
Acronym / sponsor ID: R668-AD-1924
Conditions: Moderate to Severe Atopic Hand and Foot Dermatitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: Sanofi
Study start: 14 Apr 2021 (actual)
Primary completion: 31 Aug 2022 (actual)
Study completion: 23 Nov 2022 (actual)
First posted: 5 Jun 2020 (actual)
Results: Posted 22 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
dupilumab	Experimental	Drug: dupilumabAdministered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
Matching Placebo	Experimental	Drug: PlaceboAdministered SC Q2W, following a loading dose on Day 1

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dupilumabAlso: DUPIXENT®, REGN668, SAR231893Solution for subcutaneous (SC) injection administration	Drug	dupilumab
PlaceboSolution for SC injection administration	Drug	Matching Placebo

Primary outcome

Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16
Time frame: At week 16
IGA is an assessment scale used to determine severity of hand and foot AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Higher score is indicative of more severe disease.

19 secondary outcomes

Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus Numerical Rating Scale (NRS) of ≥4 Points From Baseline to Week 16
Time frame: Baseline to week 16
Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥3 From Baseline to Week 16
Time frame: Baseline to week 16
Percent Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS
Time frame: Baseline to week 16
Percent Change in Modified Total Lesion Sign Score (mTLSS) for Hand/Foot Lesions From Baseline to Week 16
Time frame: Baseline to Week 16
Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS
Time frame: Baseline to week 16
Mean Change From Baseline to Week 16 in Weekly Average of Daily Sleep NRS
Time frame: Baseline to week 16
Change From Baseline to Week 16 in Percent Surface Area of Hand and Foot Involvement With Atopic Dermatitis (AD)
Time frame: Baseline to week 16
Percent Change From Baseline to Week 4 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS
Time frame: Baseline to week 4
Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥4 From Baseline to Week 4
Time frame: Baseline to week 4
Percent Change From Baseline to Week 16 in Hand Eczema Severity Index (HECSI) Score in Participants With Hand Dermatitis
Time frame: Baseline to week 16
Percentage of Participants With HECSI-75 at Week 16
Time frame: At week 16
Percentage of Participants With HECSI-50 at Week 16
Time frame: At week 16
Percentage of Participants With HECSI-90 at Week 16
Time frame: At week 16
Change From Baseline to Week 16 in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)
Time frame: Baseline to week 16
Mean Change From Baseline to Week 16 in Work Productivity and Impairment (WPAI) and Classroom Impairment Questionnaire (CIQ)
Time frame: Baseline to week 16
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 16
Time frame: Through week 16
Trough Concentration of Functional Dupilumab in Serum at Various Time Points
Time frame: Up to week 28
Number of Participants With Treatment-Emergent (TE) Anti-Drug Antibody (ADA)
Time frame: Up to week 28
Number of Participants With Treatment-Emergent ADA by Maximum Titer Category
Time frame: Up to Week 28

Results and safety

Results posted to the registry on 22 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Matching Placebo	66	53
Dupilumab Q2W	67	60

Primary outcome: Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16

Time frame: At week 16. Number. Unit: Percentage of participants

Measure	Matching Placebo n = 66	Dupilumab Q2W n = 67
Value	16.7	40.3

Matching Placebo vs Dupilumab Q2W: p =0.0030, Cochran-Mantel-Haenszel

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose to Week 28. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Matching Placebo	1 of 66 (1.5%)	34 of 66 (51.5%)	0 of 66
Dupilumab Q2W	3 of 67 (4.5%)	33 of 67 (49.3%)	0 of 67

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42825999Armstrong A, Kircik L, Metelitsa A, Warren RB, Rodriguez A, Volc S, Issa N, Chovatiya R, von Eyben R, Festini T, Johansen P, Ehst B. Tralokinumab Versus Dupilumab for the Treatment of Atopic Dermatitis with Moderate-to-Severe Hand Involvement: A Matching-Adjusted Indirect Comparison. Dermatol Ther (Heidelb). 2026 Oct 2. doi: 10.1007/s13555-026-01922-8. Online ahead of print.
Derived from this study: PubMed 41240207Cohen D, Bewley A, Wollenberg A, Hong HC, Armstrong A, Jonsen E, Maslin D, Thoning H, von Eyben R, Chovatiya R. Matching-Adjusted Indirect Comparison of the Efficacy of Delgocitinib Cream and Dupilumab in the Treatment of Moderate to Severe Atopic Hand Eczema. Dermatol Ther (Heidelb). 2026 Jan;16(1):423-436. doi: 10.1007/s13555-025-01592-y. Epub 2025 Nov 15.
Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trial Management study director

Regeneron Pharmaceuticals

48 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dupilumab in people with Moderate to Severe Atopic Hand and Foot Dermatitis, run by Regeneron Pharmaceuticals at 48 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Germany, Poland, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16 (time frame: At week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04417894, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.