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

NCT02277769

CompletedPhase 3

Sponsor: Regeneron Pharmaceuticals

Conditions: Dermatitis, Atopic

Interventions: Dupilumab, Placebo (for Dupilumab)

Countries: United States, Canada, France, Germany, Hong Kong, Italy, Lithuania, Poland

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (93)

Anniston, Alabama, United States
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Bakersfield, California, United States
Costa Mesa, California, United States
Fremont, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Orange, California, United States
Roseville, California, United States
Temecula, California, United States
Trumbull, Connecticut, United States
Miami, Florida, United States
Oviedo, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Alpharetta, Georgia, United States
Atlanta, Georgia, United States
Columbus, Georgia, United States
Buffalo Grove, Illinois, United States
Plainfield, Indiana, United States
West Des Moines, Iowa, United States
Overland Park, Kansas, United States
Rockville, Maryland, United States
Washington Park, Maryland, United States
Boston, Massachusetts, United States
Farmington Hills, Michigan, United States
Minneapolis, Minnesota, United States
Plymouth, Minnesota, United States
Saint Joseph, Missouri, United States
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