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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Atopic Disorders; Eczema, Atopic

Treatments: Drug: Dupilumab; Device: Auto-injector Device; Device: Prefilled syringe

Study type: Interventional

Funder types: Industry

Identifiers

NCT03050151

R668-AD-1607

Details and patient eligibility

About

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

Full 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.

Enrollment: 176 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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-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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 4 patient groups

1 - Dupilumab (Part A)

Experimental group

Description:

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

Treatment:

Device: Auto-injector Device

Drug: Dupilumab

2 - Dupilumab (Part A)

Experimental group

Description:

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

Treatment:

Device: Prefilled syringe

Drug: Dupilumab

3 - Dupilumab (Part B)

Experimental group

Description:

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

Treatment:

Device: Auto-injector Device

Drug: Dupilumab

4 - Dupilumab (Part B)

Experimental group

Description:

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

Treatment:

Device: Prefilled syringe

Drug: Dupilumab