Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Status: | Completed |
---|---|
Conditions: | Psoriasis, Dermatology, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/19/2017 |
Start Date: | September 2014 |
End Date: | October 2016 |
A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Long-Term Safety of Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis
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.
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.
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.
We found this trial at
50
sites
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