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

Eczema, Atopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03050151
• Other study ID #: R668-AD-1607
• Status: Completed
• Phase: Phase 1
• Start date: February 28, 2017
• Est. completion date: February 12, 2018

Study information

• Verified date: May 2018
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: February 12, 2018
• Est. primary completion date: November 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Key Inclusion Criteria:

1. Diagnosis of chronic atopic dermatitis for at least 3 years with inadequate response to topical medications within 6 months before screening

2. Willing and able to comply with all clinic visits and study-related procedures

3. Provide signed informed consent

Key Exclusion Criteria:

1. Patient < 30.0 kilograms (Kg) in weight

2. Patient who has previously participated in a dupilumab clinical study

3. 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-?, 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

4. 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)

5. Patient who has skin comorbidities that may interfere with study assessments

6. Patient with a planned or anticipated major surgical procedure during the patient's participation in this study

7. Women of childbearing potential unwilling to use adequate birth control measures during the study

8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Related Conditions & MeSH terms

• Atopic Disorders
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Eczema, Atopic

Intervention

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

Device:
• Auto-injector Device
Delivery of Dupilumab by auto-injector device
• Prefilled syringe
Delivery of Dupilumab by prefilled syringe

Locations

Country	Name	City	State
United States	Regeneron Investigational Site	Bellaire	Texas
United States	Regeneron Investigational Site	Berlin	New Jersey
United States	Regeneron Investigational Site	Birmingham	Alabama
United States	Regeneron Investigational Site	Birmingham	Alabama
United States	Regeneron Investigational Site	Charleston	South Carolina
United States	Regeneron Investigational Site	Coral Gables	Florida
United States	Regeneron Investigational Site	Corning	New York
United States	Regeneron Investigational Site	Denver	Colorado
United States	Regeneron Investigational Site	Forest Hills	New York
United States	Regeneron Investigational Site	Fort Smith	Arkansas
United States	Regeneron Investigational Site	Fort Worth	Texas
United States	Regeneron Investigational Site	Greer	South Carolina
United States	Regeneron Investigational Site	High Point	North Carolina
United States	Regeneron Investigational Site	Indianapolis	Indiana
United States	Regeneron Investigational Site	Long Beach	California
United States	Regeneron Investigational Site	Los Angeles	California
United States	Regeneron Investigational Site	Murrieta	California
United States	Regeneron Investigational Site	New York	New York
United States	Regeneron Investigational Site	Norfolk	Virginia
United States	Regeneron Investigational Site	Normal	Illinois
United States	Regeneron Investigational Site	Oceanside	California
United States	Regeneron Investigational Site	Orange	California
United States	Regeneron Investigational Site	Plymouth	Minnesota
United States	Regeneron Investigational Site	Portland	Oregon
United States	Regeneron Investigational Site	Raleigh	North Carolina
United States	Regeneron Investigational Site	Rockville	Maryland
United States	Regeneron Investigational Site	Rolling Hills Estates	California
United States	Regeneron Investigational Site	Saint Joseph	Missouri
United States	Regeneron Investigational Site	San Antonio	Texas
United States	Regeneron Investigational Site	San Antonio	Texas
United States	Regeneron Investigational Site	Santa Monica	California
United States	Regeneron Investigational Site	Skokie	Illinois
United States	Regeneron Investigational Site	Tacoma	Washington
United States	Regeneron Investigational Site	Tampa	Florida
United States	Regeneron Investigational Site	Tulsa	Oklahoma
United States	Regeneron Investigational Site	Webster	Texas
United States	Regeneron Investigational Site	Windsor	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of validated AI device-associated product technical failures (PTFs) during the treatment period divided by total number of actual injections		To week 12
Primary	Type of validated AI device-associated PTFs during the treatment period divided by total number of actual injections.		To week 12
Secondary	Number of patients with an AI device-associated PTF		To week 12
Secondary	Percentage of patients with an AI device-associated PTF		To week 12
Secondary	Number of AI device-associated product technical complaints (PTCs) divided by total number of actual injections		To week 12
Secondary	Type of AI device-associated PTCs divided by total number of actual injections		To week 12
Secondary	Number of patients with an AI device-associated PTC		To week 12
Secondary	Percentage of patients with an AI device-associated PTC		To week 12
Secondary	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		To week 12
Secondary	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		To week 12
Secondary	Number of patients with an AI device-associated failure to deliver dose		To week 12
Secondary	Percentage of patients with an AI device-associated failure to deliver dose		To week 12
Secondary	Number of patients with response to patient satisfaction questions with the AI device		To week 12
Secondary	Percentage of patients with response to patient satisfaction questions with the AI device		To week 12