Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

• Status: Completed
• Trial end date: 2016-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Collaborator: Sanofi
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

1. Chronic AD that has been present for at least 3 years before the screening visit;

2. ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits;

3. Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).

Exclusion Criteria:

1. Participation in a prior Dupilumab clinical study.

2. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit;

3. Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:

• Immunosuppressive/ immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)

• Phototherapy for AD

4. Regular use (more than 2 visits per week) of a tanning booth/ parlor within 4 weeks of the screening visit;

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

6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening;

7. Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit;

8. Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit;

9. Known or suspected history of immunosuppression;

10. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study;

11. Women unwilling to use adequate birth control, if of reproductive potential and sexually active.

Note: The information listed above is not intended to contain all considerations relevant to a participant's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed.