Open-label Study of Dupilumab in Patients With Atopic Dermatitis

Conditions

• Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dupilumab — DRUG

Study Details

The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD). The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment. Optional Sub-Study: The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product. The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.

Key Dates

Start date

Oct 10, 2013

Status verified

Oct 2023

Primary completion

Jun 27, 2022

Completion

Jun 27, 2022

Study Design

Enrollment

2,733 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Dupilumab
  Participants will receive repeat doses of dupilumab

Primary Outcome Measure

Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 272 weeks ]

Locations (129)

Find similar trials in Anniston, AL

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