Status:
COMPLETED
Study of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult participants with moderate-to-severe atopic dermatitis (AD).
Eligibility Criteria
Inclusion
- The inclusion criteria included, but were not limited to, the following:
- Chronic Atopic Dermatitis that had been present for at least 3 years
- 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)
- Willing and able to comply with all clinic visits and study-related procedures
- The exclusion criteria included, but were not limited to, the following:
- Prior treatment with dupilumab (REGN668/SAR231893)
- Presence of certain laboratory abnormalities at the screening visit
- Treatment with an investigational drug within 8 weeks of baseline visit
- Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
- Certain other treatments and medical procedures undertaken within a particular time frame prior to the baseline visit
- Known history of human immunodeficiency virus (HIV) infection
- History of malignancy within 5 years before the baseline visit (with certain exceptions)
- Planned surgical procedure during the length of the study
- High risk of parasite infection
- 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
- Pregnant or breast-feeding women
Exclusion
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT01859988
Start Date
May 1 2013
End Date
September 1 2014
Last Update
August 28 2017
Active Locations (84)
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1
Birmingham, Alabama, United States
2
Mobile, Alabama, United States
3
Tucson, Arizona, United States
4
Bakersfield, California, United States