NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedPhase 2

Sponsor: Regeneron Pharmaceuticals

Conditions: Atopic Dermatitis

Interventions: Dupilumab, Placebo

Countries: United States, Canada, Czechia, Germany, Hungary, Japan, Poland

To assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult participants with moderate-to-severe atopic dermatitis (AD).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

1. Chronic Atopic Dermatitis that had been present for at least 3 years
2. History of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable (e.g, because of important side effects or safety risks)
3. Willing and able to comply with all clinic visits and study-related procedures

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

1. Prior treatment with dupilumab (REGN668/SAR231893)
2. Presence of certain laboratory abnormalities at the screening visit
3. Treatment with an investigational drug within 8 weeks of baseline visit
4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
5. Certain other treatments and medical procedures undertaken within a particular time frame prior to the baseline visit
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 study
9. High risk of parasite infection
10. Any other medical or psychological condition that in the opinion of the investigator or the sponsor's medical monitor, would place the participants at risk, interfere with participation in the study or interfere with interpretation of study results
11. Pregnant or breast-feeding women

Locations (84)

Birmingham, Alabama, United States
Mobile, Alabama, United States
Tucson, Arizona, United States
Bakersfield, California, United States
San Diego, California, United States
Santa Monica, California, United States
Jacksonville, Florida, United States
Ormond Beach, Florida, United States
Skokie, Illinois, United States
New Orleans, Louisiana, United States
Andover, Massachusetts, United States
Boston, Massachusetts, United States
Troy, Michigan, United States
St Louis, Missouri, United States
New York, New York, United States
Rochester, New York, United States
Winston-Salem, North Carolina, United States
Portland, Oregon, United States
Pittsburgh, Pennsylvania, United States
Johnston, Rhode Island, United States
Greer, South Carolina, United States
Nashville, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Seattle, Washington, United States
Vancouver (2 Locations), British Columbia, Canada
Winnipeg, Manitoba, Canada
Barrie, Ontario, Canada
Hamilton, Ontario, Canada
Markham, Ontario, Canada
+ 54 more on CT.gov