Dupilumab Phase 4 Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-16

Study Completion Date

2019-08-31

Brief Summary

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The investigators will monitor for the incidence of adverse-events in a prospective, longitudinal, non-interventional and observational real-world sub-study of adults patients with moderate-to-severe AD who are receiving dupilumab as standard-of-care therapy.

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Detailed Description

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The investigators will conduct a prospective, longitudinal, non-interventional and observational sub-study of patients receiving dupilumab as normal standard-of-care treatment to assess the efficacy (Specific Aim #1) and safety (Specific Aim #2) of dupilumab for the treatment of moderate-to-severe AD, as well as the prevention and/or mitigation of comorbid health conditions (Specific Aim #3). This study will address the hypotheses that dupilumab will lead to improved long-term control and decreased severity of AD, and that long-term monitoring will shed light on the incidence of adverse drug events.

Conditions

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Atopic Dermatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dupilumab

Patients with moderated-to-severe atopic dermatitis who are receiving dupilumab as a standard of care

Dupilumab

Intervention Type BIOLOGICAL

Biologic (monoclonal antibody)

Interventions

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Dupilumab

Biologic (monoclonal antibody)

Intervention Type BIOLOGICAL

Other Intervention Names

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Dupixent

Eligibility Criteria

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Inclusion Criteria

* Individuals aged 18 and over who have been diagnosed with Atopic Dermatitis and are using dupilumab therapy as part of standard of care.
* Parents of adolescents ages 12 to 17 who have been diagnosed with Atopic Dermatitis and are receiving dupilumab off-label for the management of AD.