The Utility of Functionally Relevant Signature Genes in Assessing the Clinical Outcomes of Dupilumab Treatment

Jonathan A. Bernstein, MD

Status and phase: Completed; Phase 4

Conditions: Atopic Dermatitis; Eczema

Treatments: Biological: Dupilumab Prefilled Syringe

Study type: Interventional

Funder types: Other

Identifiers

NCT04358224

R668-AD-1830

Details and patient eligibility

About

The utility of functionally relevant signature genes in assessing the clinical outcomes of dupilumab treatment in the adult onset atopic dermatitis

Full description

The study consists of 9 visits. Duplimab will used in the treatment of adult onset atopic dermatitis. Qualified subjects will receive 5 dupilumab open-label injections. Skin biopsies/ skin strips will be obtained at the beginning and the end of treatment. TARC and IgE levels will be obtained at the beginning and end of treatment. Subjects will complete daily diaries assessing atopic dermatitis symptoms. Patient reported out comes will be completed at each visit

Enrollment: 12 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• history of adult onset atopic dermatitis

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

open-label

Other group

Description:

open-label

Treatment:

Biological: Dupilumab Prefilled Syringe