AzTrials
AzTrials

Atopic DisordersPhase 1NCT03050151

Study of Dupilumab Auto-injector Device When Used by Patients With Atopic Dermatitis

A Phase 1 study testing Dupilumab, Auto-injector Device and Prefilled syringe in people with Atopic Disorders and Eczema, Atopic, run by Regeneron Pharmaceuticals at 37 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Atopic Disorders, Eczema, Atopic
What is being tested?
Dupilumab, Auto-injector Device and Prefilled syringe
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
37 sitesUnited States
Study dates
28 Feb 2017to 12 Feb 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

United States37 sites

  • Regeneron Investigational Site

    Bellaire, Texas, 77401

  • Regeneron Investigational Site

    Berlin, New Jersey, 08009

  • Regeneron Investigational Site

    Birmingham, Alabama, 35205

  • Regeneron Investigational Site

    Birmingham, Alabama, 35209

  • Regeneron Investigational Site

    Charleston, South Carolina, 29420

  • Regeneron Investigational Site

    Coral Gables, Florida, 33613

  • Regeneron Investigational Site

    Corning, New York, 14830

  • Regeneron Investigational Site

    Denver, Colorado, 80220

  • Regeneron Investigational Site

    Forest Hills, New York, 11375

  • Regeneron Investigational Site

    Fort Smith, Arkansas, 72916

  • Regeneron Investigational Site

    Fort Worth, Texas, 76244

  • Regeneron Investigational Site

    Greer, South Carolina, 29650

  • Regeneron Investigational Site

    High Point, North Carolina, 27262

  • Regeneron Investigational Site

    Indianapolis, Indiana, 46256

  • Regeneron Investigational Site

    Long Beach, California, 90808

  • Regeneron Investigational Site

    Los Angeles, California, 90025

  • Regeneron Investigational Site

    Murrieta, California, 92562

  • Regeneron Investigational Site

    New York, New York, 10029

  • Regeneron Investigational Site

    Norfolk, Virginia, 23502

  • Regeneron Investigational Site

    Normal, Illinois, 61761

  • Regeneron Investigational Site

    Oceanside, California, 92056

  • Regeneron Investigational Site

    Orange, California, 92868

  • Regeneron Investigational Site

    Plymouth, Minnesota, 55441

  • Regeneron Investigational Site

    Portland, Oregon, 97223

  • Regeneron Investigational Site

    Raleigh, North Carolina, 27612

  • Regeneron Investigational Site

    Rockville, Maryland, 20850

  • Regeneron Investigational Site

    Rolling Hills Estates, California, 90274

  • Regeneron Investigational Site

    Saint Joseph, Missouri, 64506

  • Regeneron Investigational Site

    San Antonio, Texas, 78213

  • Regeneron Investigational Site

    San Antonio, Texas, 78218

  • Regeneron Investigational Site

    Santa Monica, California, 90404

  • Regeneron Investigational Site

    Skokie, Illinois, 60077

  • Regeneron Investigational Site

    Tacoma, Washington, 98405

  • Regeneron Investigational Site

    Tampa, Florida, 33612

  • Regeneron Investigational Site

    Tulsa, Oklahoma, 74136

  • Regeneron Investigational Site

    Webster, Texas, 77598

  • Regeneron Investigational Site

    Windsor, New Jersey, 08520

Other trials in United States

About this study

Official title: An Open-label, Randomized, Actual Use Study of Dupilumab Auto-injector Device in Patients With Atopic Dermatitis

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

Read the detailed description

Study is conducted in 2 parts: part A and part B.

Part A - Patients with moderate-to-severe AD will be randomized to receive dupilumab (dose 1) by auto-injector (AI) device or prefilled syringe.

Once part A is completely enrolled, part B will randomize patients with moderate-to-severe AD to receive dupilumab (dose 2) by auto-injector (AI) device or prefilled syringe.

Being tested
Dupilumab, Auto-injector Device, Prefilled syringe
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DupilumabDrug

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

  • Auto-injector DeviceDevice

    Delivery of Dupilumab by auto-injector device

  • Prefilled syringeDevice

    Delivery of Dupilumab by prefilled syringe

Study groups in NCT03050151
Study groupRoleWhat they receive
1 - Dupilumab (Part A)ExperimentalDose (dose 1) as per protocol delivered by auto-injector device
Receives: Drug: Dupilumab; Device: Auto-injector Device
2 - Dupilumab (Part A)ExperimentalDose (dose 1) as per protocol delivered by prefilled syringe
Receives: Drug: Dupilumab; Device: Prefilled syringe
3 - Dupilumab (Part B)ExperimentalDose (dose 2) as per protocol delivered by auto-injector device
Receives: Drug: Dupilumab; Device: Auto-injector Device
4 - Dupilumab (Part B)ExperimentalDose (dose 2) as per protocol delivered by prefilled syringe
Receives: Drug: Dupilumab; Device: Prefilled syringe

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: To week 12

  2. Type of validated AI device-associated PTFs during the treatment period divided by total number of actual injections.

    Measured: To week 12

Secondary outcomes (12)

  1. Number of patients with an AI device-associated PTF

    Measured: To week 12

  2. Percentage of patients with an AI device-associated PTF

    Measured: To week 12

  3. Number of AI device-associated product technical complaints (PTCs) divided by total number of actual injections

    Measured: To week 12

  4. Type of AI device-associated PTCs divided by total number of actual injections

    Measured: To week 12

  5. Number of patients with an AI device-associated PTC

    Measured: To week 12

  6. Percentage of patients with an AI device-associated PTC

    Measured: To week 12

  7. Number of AI device-associated failed drug deliveries (defined as patient failure to administer the full dose at a given attempt, excluding PTF) divided by total number of actual injections

    Measured: To week 12

  8. Type of AI device-associated failed drug deliveries (defined as patient failure to administer the full dose at a given attempt, excluding PTF) divided by total number of actual injections

    Measured: To week 12

  9. Number of patients with an AI device-associated failure to deliver dose

    Measured: To week 12

  10. Percentage of patients with an AI device-associated failure to deliver dose

    Measured: To week 12

  11. Number of patients with response to patient satisfaction questions with the AI device

    Measured: To week 12

  12. Percentage of patients with response to patient satisfaction questions with the AI device

    Measured: To week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2017
  2. Study start28 Feb 2017
  3. Primary completion14 Nov 2017
  4. Study completion12 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03050151
Sponsor's protocol ID
R668-AD-1607
Status last verified
May 2018
First submitted
8 Feb 2017
Last updated
1 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes

Publications

  • Blauvelt A, Guttman-Yassky E, Paller AS, Simpson EL, Cork MJ, Weisman J, Browning J, Soong W, Sun X, Chen Z, Kosloski MP, Kamal MA, Delevry D, Chuang CC, O'Malley JT, Bansal A. Long-Term Efficacy and Safety of Dupilumab in Adolescents with Moderate-to-Severe Atopic Dermatitis: Results Through Week 52 from a Phase III Open-Label Extension Trial (LIBERTY AD PED-OLE). Am J Clin Dermatol. 2022 May;23(3):365-383. doi: 10.1007/s40257-022-00683-2. Epub 2022 May 14.

    PubMed 35567671

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dupilumab, Auto-injector Device and Prefilled syringe in people with Atopic Disorders and Eczema, Atopic, run by Regeneron Pharmaceuticals at 37 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of validated AI device-associated product technical failures (PTFs) during the treatment period divided by total number of actual injections (time frame: To week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03050151, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in