Status:
COMPLETED
Study of Dupilumab and Immune Responses in Adults With Atopic Dermatitis (AD)
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
This was a 32-week, randomized, double-blind, placebo-controlled, parallel-group study assessing immunization responses to vaccination in adults with moderate to severe atopic dermatitis who are treat...
Eligibility Criteria
Inclusion
- Key
- Male or female adults ages 18 to 64 years with Chronic AD (according to the American Academy of Dermatology Consensus Criteria, \[Eichenfeld 2004\])that has been present for at least 3 years before the screening visit
- Participants 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 otherwise inadvisable (e.g., because of side effects or safety risks).
- Eczema Area and Severity Index (EASI) score ≥16 at the screening visit and the baseline visit
- Investigator's Global Assessment (IGA) score ≥3 (on the 0-4 IGA scale) at the screening and baseline visits
- ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits
- Key
Exclusion
- Prior treatment with dupilumab (REGN668/ SAR231893)
- Patients needing \>10 mg of daily prednisone (including equivalent doses of other steroids) or high dose systemic corticosteroids (≥2 mg/kg) for 14 days or longer during the 16 week treatment period of the study
- History of Guillain-Barre syndrome
- History of severe allergic reaction to either vaccine or to vaccine components including alum, thimerosal, phenol
- Patients with a severe reaction to natural rubber latex products (some packaging components of the vaccines contain rubber latex and may cause a reaction in susceptible individuals)
- Treatment with biologics within 4 months of baseline visit
- Chronic or acute infection requiring treatment with antibiotics, antivirals, antiparasitics, antifungals within 4 weeks before screening visit or superficial skin infections within 1 week of screening visit
- The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.
Key Trial Info
Start Date :
August 5 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2015
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT02210780
Start Date
August 5 2014
End Date
September 15 2015
Last Update
May 7 2020
Active Locations (42)
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1
Birmingham, Alabama, United States
2
Fort Smith, Arkansas, United States
3
Long Beach, California, United States
4
Los Angeles, California, United States