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

NCT04823130 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-09-16

Study results available
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Summary

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.

Conditions

  • Dermatitis Atopic

Interventions

DRUG

Dupilumab (SAR231893)

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-22
Primary Completion
2022-06-30
Completion
2022-08-30
FDA Drug
Yes

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04823130 on ClinicalTrials.gov