NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis

NCT02260986

CompletedPhase 3

Sponsor: Regeneron Pharmaceuticals

Conditions: Atopic Dermatitis

Interventions: Dupilumab, Placebo (for Dupilumab), Topical Corticosteroid (TCS)

Countries: United States, Australia, Canada, Czechia, Hungary, Italy, Japan, Netherlands

The primary objective of the study was to demonstrate the efficacy of Dupilumab administered concomitantly with topical corticosteroid (TCS) through Week 16 in adult participants with moderate-to-severe atopic dermatitis (AD) compared to placebo administered concomitantly with TCS.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

1. Chronic AD that had been present for at least 3 years before the screening visit;
2. Documented recent history (within 6 months before the screening visit) of inadequate response to a sufficient course of out-patient treatment with topical AD medication(s).

Key Exclusion Criteria:

1. Participation in a prior Dupilumab clinical trial;
2. Important side effects of topical medication (e.g. intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or treating physician;
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, was likely to require such treatment(s) during the first 2 weeks of study treatment:

   1. Immunosuppressive/immunomodulating drugs (e.g, systemic steroids, cyclosporine, mycophenolate-mofetil, Janus kinase inhibitors, interferon-gamma \[IFN-γ\], azathioprine, methotrexate, etc.);
   2. Phototherapy for AD;
4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
5. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening;
6. Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at the screening visit;
7. Active or acute infection requiring systemic treatment within 2 weeks before baseline visit;
8. Known or suspected history of immunosuppression;
9. Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the participant's participation in this study.

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

Locations (148)

Phoenix, Arizona, United States
Hot Springs, Arkansas, United States
Little Rock, Arkansas, United States
Encinitas, California, United States
Oceanside, California, United States
Palmdale, California, United States
San Diego, California, United States
New Haven, Connecticut, United States
Trumbull, Connecticut, United States
Edgewater, Florida, United States
Lake Worth, Florida, United States
Miami Lakes, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Alpharetta, Georgia, United States
Columbus, Georgia, United States
Savannah, Georgia, United States
West Dundee, Illinois, United States
Carmel, Indiana, United States
New Albany, Indiana, United States
Rockville, Maryland, United States
Ann Arbor, Michigan, United States
Bay City, Michigan, United States
Edina, Minnesota, United States
Fridley, Minnesota, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Henderson, Nevada, United States
Verona, New Jersey, United States
Albuquerque, New Mexico, United States
+ 118 more on CT.gov