Dupilumab Phase 4 Study

Dupilumab Registry Study

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03411837

Acronym

DRS

Enrollment

Registered

2018-01-26

Start date

2017-10-16

Completion date

2019-08-31

Last updated

2021-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis, dupilumab

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICALDupilumab

Biologic (monoclonal antibody)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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.

Exclusion criteria

* Patients not on dupilumab * Those who do not comply with the study requirements * Those who do not provide informed consent

Design outcomes

Primary

Measure	Time frame
Quantified Itch Survey	1 to 3 months
Quantified Sleep Survey	1 to 3 months
Quantified Quality of Life Survey	1 to 3 months

Secondary

Measure	Time frame	Description
Occurrence of any AEs by 24 months	24 months	Will be determined based off of patient reported safety events
Occurrence of any infections by 24 months	24 months	Will be determined based off of patient reported safety events
Occurrence of any SAEs by 24 months	24 months	Will be determined based off of patient reported safety events

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026