NCT04520308

An Open-label, Single-arm Longitudinal Study With Dupilumab for Patients With Atopic Dermatitis

Effects of Interleukin (IL)-4/IL-13 Blockade on the Structure and Function of Cutaneous Sensory Nerves: An Open-label, Single-arm Longitudinal Study With Dupilumab

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Eric Simpson · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

24-week, open-label, single-arm longitudinal study of patients with AD, including a comparison between baseline values for adult patients with moderate-to-severe AD and untreated normal control patients. Patients with AD: ≤24 to 29 weeks, including the screening period Normal control patients: ≤2 days to 5 weeks, including the screening period. Patients with AD: adults with moderate-to-severe AD whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable (eg, intolerance, other important side effects or safety risks) Normal control patients: adults without AD or other atopic disease

Conditions

• Atopic Dermatitis
• AD
• Eczema

Interventions

Type	Name	Description
DRUG	Dupilumab Only Product	SC injections of 300 mg dupilumab every 2 weeks for 24 weeks following a loading dose of 600 mg on day 1

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-02-26
• Completion: 2021-03-31
• First posted: 2020-08-20
• Last updated: 2020-08-20

Regulatory

• FDA-regulated drug study