Brief Summary

To collect data on actual-use to assess technical performance and user injections of dupilumab auto-injection device by patients with atopic dermatitis (AD).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

176

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Feb 2017

Geographic Reach

1 country

37 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12 months study duration

First Submitted

Initial submission to the registry

February 8, 2017

Completed

2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed

18 days until next milestone

Study Start

First participant enrolled

February 28, 2017

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2017

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2018

Completed

Last Updated

August 1, 2018

Status Verified

May 1, 2018

Enrollment Period

9 months

First QC Date

February 8, 2017

Last Update Submit

July 30, 2018

Conditions

Atopic Disorders Eczema, Atopic

Outcome Measures

Primary Outcomes (2)

Number of validated AI device-associated product technical failures (PTFs) during the treatment period divided by total number of actual injections
To week 12
Type of validated AI device-associated PTFs during the treatment period divided by total number of actual injections.
To week 12

Secondary Outcomes (12)

Number of patients with an AI device-associated PTF
To week 12
Percentage of patients with an AI device-associated PTF
To week 12
Number of AI device-associated product technical complaints (PTCs) divided by total number of actual injections
To week 12
Type of AI device-associated PTCs divided by total number of actual injections
To week 12
Number of patients with an AI device-associated PTC
To week 12
+7 more secondary outcomes

Study Arms (4)

1 - Dupilumab (Part A)

EXPERIMENTAL

Dose (dose 1) as per protocol delivered by auto-injector device

Drug: DupilumabDevice: Auto-injector Device

2 - Dupilumab (Part A)

EXPERIMENTAL

Dose (dose 1) as per protocol delivered by prefilled syringe

Drug: DupilumabDevice: Prefilled syringe

3 - Dupilumab (Part B)

EXPERIMENTAL

Dose (dose 2) as per protocol delivered by auto-injector device

Drug: DupilumabDevice: Auto-injector Device

4 - Dupilumab (Part B)

EXPERIMENTAL

Dose (dose 2) as per protocol delivered by prefilled syringe

Drug: DupilumabDevice: Prefilled syringe

Interventions

DupilumabDRUG

Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe

1 - Dupilumab (Part A)2 - Dupilumab (Part A)3 - Dupilumab (Part B)4 - Dupilumab (Part B)

Auto-injector DeviceDEVICE

Delivery of Dupilumab by auto-injector device

1 - Dupilumab (Part A)3 - Dupilumab (Part B)

Prefilled syringeDEVICE

Delivery of Dupilumab by prefilled syringe

2 - Dupilumab (Part A)4 - Dupilumab (Part B)

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of chronic atopic dermatitis for at least 3 years with inadequate response to topical medications within 6 months before screening
Willing and able to comply with all clinic visits and study-related procedures
Provide signed informed consent

You may not qualify if:

Patient \< 30.0 kilograms (Kg) in weight
Patient who has previously participated in a dupilumab clinical study
Patient who has been treated with the following:
An investigational drug within 8 weeks or within 5 half-lives (if known),whichever is longer, before the baseline visit
Immunosuppressive/ immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mufti, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.) or Phototherapy for AD within 4 weeks before the baseline visit
An experimental monoclonal antibody within 5 half-lives or within 6◦months prior to visit 1 if the half-life is unknown
Biologic agents within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever is longer
Anti-immunoglobulin E therapy (omalizumab) within 130 days prior to visit 1
A live (attenuated) vaccine within 4 weeks before the baseline visit
Patient who has initiated treatment with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit)
Patient who has skin comorbidities that may interfere with study assessments
Patient with a planned or anticipated major surgical procedure during the patient's participation in this study
Women of childbearing potential unwilling to use adequate birth control measures during the study
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Contact the study team to confirm eligibility.