EFFICACY AND LONG TERM SAFETY STUDY OF DUPILUMAB IN ADULT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS.
- Conditions
- Moderate to severe atopic dermatitis (AD).MedDRA version: 17.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2013-003254-24-ES
- Lead Sponsor
- Regeneron Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
1. Male or female, 18 years or older
2. Chronic AD, (according to the American Academy of Dermatology Consensus Criteria),that has been present for at least 3 years before the screening visit.
3. Patients with documented recent history (within 6 months before the
screening visit) of inadequate response to a sufficient course of
outpatient treatment with topical AD medication(s), or for whom topical AD therapies are medically inadvisable.
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 382
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 68
1. Prior treatment with dupilumab
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. Patients of reproductive potential and sexually active who are
unwilling to use adequate contracepcion.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assess the efficacy of dupilumab over 12 weeks of treatment in adult<br>patients with moderate-to-severe atopic dermatitis (AD) who have failed or are intolerant to topical steroids with or without topical calcineurin inhibitors.;Secondary Objective: -Evaluate efficacy over time of dupilumab when administered for up to 52 weeks.<br>-Evaluate the long-term safety of dupilumab administered for up to 52 weeks.;Primary end point(s): - Percentage of patients with EASI-50 response (reduction of EASI score by at least 50% from baseline) at week 12.<br>- Percentage of patients with IGA 0 or 1 at week 12;Timepoint(s) of evaluation of this end point: Week 12
- Secondary Outcome Measures
Name Time Method