EUCTR2012-003651-11-PL
Active, not recruiting
Not Applicable
A randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study investigating the efficacy, safety, pharmacokinetic and biomarker profiles of Dupilumab (REGN668) administered to adult patients with moderate-to-severe Atopic dermatitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atopic dermatits
- Sponsor
- Regeneron Pharmaceuticals, Inc.
- Enrollment
- 240
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult patients with moderate to severe atopic dermatitis whose disease cannot be adequately controlled with topical medications
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 200
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 40
Exclusion Criteria
- •1\. Prior treatment with REGN668
- •2\. Recent treatment (within specific time windows before the baseline visit) with systemic corticosteroids, immunosuppressive agents, topical corticosteroids and calcineurin inhibitors, live (attenuated) vaccine, other investigational drugs
- •3\. History of human immunodeficiency virus (HIV) infection
- •4\. HIV or viral hepatitis seropositivity at screening
- •5\. Known or suspected immunosuppresion
- •6\. Recent infections requiring antiinfectious treatment
- •7\. Recent history or high risk of clinical endoparasitoses
- •8\. High risk populations (low life expectancy, severe concomitant diseases, etc.)
- •9\. Pregnant or breast\-feeding women
- •10\. Female patients of reproductive potential and sexually active who are unwilling to use adequate contraception
Outcomes
Primary Outcomes
Not specified
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