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

First listed

Mar 30, 2021

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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