Dupilumab Effect on Pruritus Neuro-mechanisms in Patients With Atopic Dermatitis

Conditions

• Dermatitis Atopic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Dupilumab (SAR231893) — DRUG
  Pharmaceutical form: solution for injection Route of administration: subcutaneous

Study Details

Primary Objective: \- Assess change in neuronal architecture following long term treatment with dupilumab in skin biopsies from atopic dermatitis (AD) participants with chronic pruritus. Secondary Objectives: * Assess change in neuronal architecture following short term treatment with dupilumab and during follow-up in skin biopsies from AD participants with chronic pruritus. * To evaluate the efficacy of dupilumab in AD participants with chronic pruritus. * To evaluate the safety of dupilumab in adult participants with moderate-to-severe AD.

Key Dates

Start date

Apr 22, 2021

Status verified

Sep 2025

Primary completion

Jun 30, 2022

Completion

Aug 30, 2022

Study Design

Enrollment

54 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• No Intervention: Healthy Participants: Control
  Healthy participants with site, age, gender, race, location of targeted lesional and non-lesional skin area matched to selected AD participants, received no treatment, and were considered as a control group.
• Experimental: Participants With AD: Dupilumab
  Participants with moderate to severe AD received dupilumab 600 milligrams (mg) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) from Week 3 to Week 15.

Primary Outcome Measure

Change From Baseline in Intraepidermal Nerve Fiber Density on Lesional Skin at Week 17 [ Time Frame: Baseline, Week 17 ]

Locations (2)

Find similar trials in Miami, FL

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