A study to determine the appropriate dose(s) of Dupilumab (REGN668) in adult patients with moderate to severe atopic dermatitis (eczema)

• Conditions: Atopic dermatits; MedDRA version: 16.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2012-003651-11-DE
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-23
• Last Update Posted: 8 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified