Study of Dupilumab in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective was to assess the clinical efficacy of repeated subcutaneous (SC) doses of Dupilumab in adult participants with moderate-to-severe atopic dermatitis (AD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Collaborator: Sanofi

Criteria

Inclusion Criteria:

The inclusion criteria included, but were not limited to the following:

1. Male or female, 18 years or older;

2. Chronic Atopic Dermatitis (AD) for at least 3 years;

3. History of inadequate response to a stable (>/= 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit.

Exclusion Criteria:

1. Prior treatment with REGN668;

2. Presence of certain laboratory abnormalities at the screening visit;

3. Treatment with an investigational drug within 8 weeks ;

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

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

6. Known history of human immunodeficiency virus (HIV) infection;

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

8. Planned surgical procedure during the length of the patient's participation in this study;

9. History of clinical parasite infection;

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

11. Pregnant or breast-feeding women.