EUCTR2015-002653-35-NL
Active, not recruiting
Phase 1
A phase 3 study investigating the efficacy, safety, and tolerability of Dupilumab administered to adult patients with severe atopic dermatitis who are not adequately controlled with or are intolerant to oral cyclosporine A, or when this treatment is not medically advisable
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Regeneron Pharmaceuticals, Inc.
- Enrollment
- 330
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female, 18 years or older
- •2\. Severe, Chronic AD, (according to American Academy of Dermatology Consensus Criteria \[Eichenfield 2014])
- •3\. EASI score \=20 at the screening and baseline visits
- •4\. IGA score \=3 (on the 0 to 4 IGA scale) at the screening and baseline visits
- •5\. \=10% body surface area (BSA) of AD involvement at the screening and baseline visits
- •6\. Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with TCS
- •7\. Have applied a stable dose of topical emollient (moisturizer) twice daily for at least the 7 consecutive days immediately before the baseline visit
- •8\. Documented history by a physician of either:
- •A. No prior CSA exposure and not currently a candidate for CSA treatment due to:
- •medical contraindications (eg, uncontrolled hypertension on medication), or
Exclusion Criteria
- •1\. Participation in a prior dupilumab clinical study
- •2\. Treatment with an investigational drug within 8 weeks or within 5 half\-lives (if known), whichever is longer, before the screening visit
- •3\. Hypersensitivity and/or intolerance to corticosteroids or to any other ingredients contained in the TCS product used in the study
- •4\. Systemic CSA, systemic corticosteroids, or phototherapy within 4 weeks prior to screening, and azathioprine (AZA), methotrexate (MTX), mycophenolate mofetil (MMF), or Janus kinase (JAK) inhibitors within 8 weeks prior to screening
- •5\. Treatment with TCI within 1 week before the screening visit
- •6\. Treatment with biologics as follows:
- •Any cell\-depleting agents including but not limited to rituximab: within 6 months before the screening visit, or until lymphocyte count returns to normal, whichever is longer
- •Other biologics: within 5 half\-lives (if known) or 16 weeks prior to the screening visit, whichever is longer
- •7\. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit
- •8\. Treatment with a live (attenuated) vaccine within 12 weeks before the screening
Outcomes
Primary Outcomes
Not specified
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