Dupilumab Phase 4 Study

Terminated

• Conditions: Atopic Dermatitis
• Interventions: Biological: Dupilumab

• Registration Number: NCT03411837
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study Start: 2017-10-16
• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2018-01-19
• Study First Posted: 2018-01-26
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-06
• Last Update Posted: 2021-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Quantified Itch Survey	1 to 3 months
Quantified Quality of Life Survey	1 to 3 months
Quantified Sleep Survey	1 to 3 months

Secondary Outcome Measures

Name	Time	Method
Occurrence of any SAEs by 24 months	24 months	Will be determined based off of patient reported safety events
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

Trial Locations

Locations (1)

Northwestern University Department of Dermatology; 🇺🇸 Chicago, Illinois, United States