Status:
COMPLETED
Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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-seve...
Eligibility Criteria
Inclusion
- Key
- Chronic AD that had been present for at least 3 years before the screening visit;
- 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
- Participation in a prior Dupilumab clinical trial;
- 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;
- 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:
- Immunosuppressive/immunomodulating drugs (e.g, systemic steroids, cyclosporine, mycophenolate-mofetil, Janus kinase inhibitors, interferon-gamma \[IFN-γ\], azathioprine, methotrexate, etc.);
- Phototherapy for AD;
- Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
- History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening;
- Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at the screening visit;
- Active or acute infection requiring systemic treatment within 2 weeks before baseline visit;
- Known or suspected history of immunosuppression;
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
740 Patients enrolled
Trial Details
Trial ID
NCT02260986
Start Date
September 1 2014
End Date
October 1 2016
Last Update
October 17 2017
Active Locations (148)
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1
Phoenix, Arizona, United States
2
Hot Springs, Arkansas, United States
3
Little Rock, Arkansas, United States
4
Encinitas, California, United States