CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 133 enrolled
Drug / intervention
dupilumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04417894
NCT04417894Phase 3Completed

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

Regeneron Pharmaceuticals·interventional·Posted Jun 5, 2020·Updated Dec 22, 2023

In Brief

A Phase 3 clinical trial evaluating dupilumab and Placebo for Moderate to Severe Atopic Hand and Foot Dermatitis. Completed, enrolled 133 participants across 48 sites in 4 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Japan, Poland, United States
CollaboratorsSanofi

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJun 5, 2020
Enrollment StartApr 14, 2021
Primary CompletionAug 31, 2022
Study CompletionNov 23, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 6.1 years ago

Interventions

dupilumabdrug

Solution for subcutaneous (SC) injection administration

Placebodrug

Solution for SC injection administration