Study of Dupilumab to Demonstrate Efficacy in Subjects With Nummular Eczema

Conditions

• Nummular Eczema

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Experimental: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] — DRUG
  Subcutaneous

Study Details

Nummular eczema (NE) is an idiopathic chronic inflammatory skin disease that occurs throughout all life periods. Diagnosis is made primarily clinically in correlation with histological findings. Treatment of NE is difficult. Standard treatment consists of the use of emollients, topical as well as systemic corticosteroids and phototherapy. Nevertheless, remission is hard to achieve and relapse occurs often. Patients usually suffer from severe pruritus and reduced quality of life. Therefore, new therapeutic strategies are urgently needed. Dupilumab (Dupixent®), a monoclonal antibody inhibiting the IL-4 and IL-13 pathway by targeting the IL-4-receptor, has been approved for the treatment of moderate-to-severe atopic dermatitis (AD). Since there is an overlap between AD and NE with both being caused by impaired epidermal barrier, broad immune-mediated inflammation and microbial skin colonization, using Dupilumab in NE seems to be promising.

Key Dates

Start date

Mar 30, 2021

Status verified

Jun 2025

Primary completion

Sep 1, 2025

Completion

Jan 31, 2027

Study Design

Enrollment

70 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dupilumab
  Patients randomized to this arm will receive two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by single 300 mg injection of Dupilumab every 2 weeks (q2w) from week 2 to week 16.
• Placebo Comparator: Placebo
  Patients randomized to this arm will receive identically matching doses of placebo. Two subcutaneous injections of placebo as a loading dose (to mimic the experimental Dupilumab arm) on Day 1 followed by a single injection q2w from Week 2 to Week 16.

Primary Outcome Measure

EASI [ Time Frame: From baseline to week 16. ]