Overview

Study to Assess the Safety of Dupilumab (REGN668/SAR231893) Administered Concomitantly With Topical Corticosteroids (TCS) in Patients With Moderate-to-severe Atopic Dermatitis (AD)

Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to-severe atopic dermatitis (AD).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborator:
Sanofi
Treatments:
Antibodies, Monoclonal
Criteria
Inclusion Criteria:

1. Male and female patients aged 18 years or older

2. Chronic AD that had been present for at least 2 years

Exclusion Criteria:

1. Prior treatment with Dupilumab

2. Hypersensitivity to corticosteroids or to any other ingredients contained by the TCS
product used in the study

3. AD lesions located on face, flexural, and genital areas

4. Certain treatments and medical procedures, undertaken within a particular time frame
prior to the baseline visit, preclude eligibility for participation in the study

5. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit

6. Treatment with an investigational drug within 8 weeks

7. Known history of human immunodeficiency virus (HIV) infection

8. Presence of certain laboratory abnormalities at the screening visit

9. History of certain opportunistic infections or certain clinical parasite infections

10. History of malignancy within 5 years before the baseline visit, with certain
exceptions

11. Pregnant or breast-feeding women

12. Travel within 12 months of study start to areas endemic for parasitic infections, such
as developing countries in Africa and the tropical and subtropical regions of Asia

13. History of alcohol or drug abuse within 2 years of the screening visit

14. Any medical or psychiatric condition which, in the opinion of the investigator or the
sponsor's medical monitor, would place the patient at risk, interfere with
participation in the study, or interfere with the interpretation of study results