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Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)
Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)
CompletedPhase 2
Sponsor: Regeneron Pharmaceuticals
Conditions: Atopic Dermatitis (AD)
Interventions: Dupilumab, Placebo, Background treatment
Countries: United States, Canada
The primary objective of the study was to assess the efficacy of Dupilumab, compared to placebo, in adult patients 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. Male or female, 18 years or older; 2. Chronic AD that had been present for at least 3 years before the screening visit; 3. Patients with documented recent history (within 6 months before the screening visit) of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable; 4. Willing and able to comply with all clinic visits and study-related procedures. Exclusion Criteria: 1. Prior participation in a Dupilumab clinical trial; 2. Treatment with an investigational drug within 8 weeks or within 5 half-lives before the baseline visit; 3. The following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, will likely require such treatment(s) during the first 4 weeks of study treatment: * Systemic corticosteroids; * Immunosuppressive/immunomodulating drugs; * Phototherapy for AD; 4. Treatment with topical corticosteroids, tacrolimus and/or pimecrolimus within 1 week before the baseline visit; 5. Treatment with certain biologics; 6. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit; 7. Planned major surgical procedure during the participant's participation in this study; 8. Participant was a member of the investigational team or his/her immediate family; 9. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit 10. Pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study; Note: The information 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 (4)
- Chicago, Illinois, United States
- New York, New York, United States
- Dallas, Texas, United States
- Montreal, Quebec, Canada