Dupilumab in Severe Chronic Hand Eczema

Conditions

• Hand Eczema

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Dupilumab — DRUG
  Dupilumab injections (blinded labels)
• Placebo — DRUG
  Placebo injections (blinded labels), matching the dupilumab injections in quantity and appearance

Study Details

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

Key Dates

Start date

Aug 1, 2020

Status verified

Aug 2022

Primary completion

Aug 31, 2022

Completion

Aug 31, 2022

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Dupilumab
  Patients with severe hand eczema with an inadequate response or intolerance to alitretinoin. This group will receive dupilumab injections (600mg subcutaneously as a loading dose, followed by 300mg subcutaneously once every two weeks).
• Placebo Comparator: Placebo
  Patients with severe hand eczema with an inadequate response or intolerance to alitretinoin. This group will receive placebo injections (600mg subcutaneously as a loading dose, followed by 300mg subcutaneously once every two weeks).

Primary Outcome Measure

Response to treatment/hand eczema severity (Hand Eczema Severity Index, HECSI) [ Time Frame: 16 weeks ]