NCT04512339: DUPSHE

Dupilumab in Severe Chronic Hand Eczema With Inadequate Response or Intolerance to Alitretinoin

Status unknown Phase 2 Last updated 18 August 2022

What this trial tests

Phase 2 trial testing Dupilumab in Hand Eczema in 30 participants. Status unknown.

Timeline

1 August 2020

Primary endpoint
1 August 2022

1 August 2022

Quick facts

Lead sponsor	University Medical Center Groningen
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	30
Start date	1 August 2020
Primary completion	1 August 2022
Estimated completion	1 August 2022
Sites	1 location across Netherlands

Drugs / interventions tested

• Dupilumab (DUPILUMAB) — full drug profile →
• Placebo

Conditions studied

• Hand Eczema — all drugs for Hand Eczema →

Sponsor

University Medical Center Groningen

Who can join

Adults 18 to 75, any sex, with Hand Eczema. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Response to treatment/hand eczema severity (Hand Eczema Severity Index, HECSI)
  Time frame: 16 weeks
  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)

Sponsor's own description

The purpose of this study is to investigate the efficacy of dupilumab in hand eczema patients with an inadequate response or intolerance to alitretinoin.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dupilumab in Inflammatory Skin Diseases: A Systematic Review.
   Olbrich H, Sadik CD, Ludwig RJ, Thaçi D, et al · · 2023 · cited 67× · PMID 37189381 · DOI 10.3390/biom13040634
2. Efficacy and safety of dupilumab in patients with severe chronic hand eczema with inadequate response or intolerance to alitretinoin: a randomized, double-blind, placebo-controlled phase IIb proof-of-concept study.
   Voorberg AN, Kamphuis E, Christoffers WA, Schuttelaar MLA. · · 2023 · cited 33× · PMID 37170922 · DOI 10.1093/bjd/ljad156
3. Targeting interleukin 4 and interleukin 13: a novel therapeutic approach in bullous pemphigoid.
   Chen F, Wang Y, Chen X, Yang N, et al · · 2023 · cited 10× · PMID 36999962 · DOI 10.1080/07853890.2023.2188487
4. Effective Host-Directed Therapy for Tuberculosis by Depletion of Myeloid-Derived Suppressor Cells and Related Cells Using a Diphtheria Toxin Fusion Protein.
   Parveen S, Lun S, Urbanowski ME, Cardin M, et al · · 2021 · cited 8× · PMID 33955457 · DOI 10.1093/infdis/jiab235