Dupilumab Phase 4 Study | NCT03411837

Studies
Dupilumab Phase 4 Study

NCT03411837

Sponsor

Northwestern University

Status

Terminated

Last Update Posted

Oct 12, 2021Actual

Enrollment

46Actual

Phase

Not provided

Conditions

Atopic Dermatitis

Interventions

Dupilumab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Investigator moved from institution.

Expanded Access Info

Start Date

Oct 16, 2017Actual

Primary Completion Date

Aug 31, 2019Actual

Completion Date

Aug 31, 2019Actual

First Submitted Date

Nov 13, 2017

First Submission Date that Met QC Criteria

Jan 19, 2018

First Posted Date

Jan 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2021

Last Update Posted Date

Oct 12, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dupilumab		Patients with moderated-to-severe atopic dermatitis who are receiving dupilumab as a standard of care	Biological: Dupilumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dupilumab	Biological	Biologic (monoclonal antibody)	Dupilumab	Dupixent

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients diagnosed with moderate-to-severe atopic dermatitis on dupilumab

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University Department of Dermatology		Chicago	Illinois	60611	United States

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C582203	dupilumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided