Study to Assess the Safety of Dupilumab (REGN668/SAR231893) Administered Concomitantly With Topical Corticosteroids (TCS) in Patients With Moderate-to-severe Atopic Dermatitis (AD)
NCT ID: NCT01639040
Last Updated: 2017-10-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2012-07-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo QW
Placebo (for Dupilumab) once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent topical corticosteroid (TCS) for up to 28 days
Placebo (for Dupilumab)
Placebo (for Dupilumab) once weekly (QW) for 4 weeks
Topical Corticosteroid (TCS)
TCS such as methylprednisolone aceponate 0.1%, mometasone furoate 0.1%, or betamethasone valerate 0.1%
Dupilumab 300 mg QW
Dupilumab 300 mg once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days
Dupilumab
Dupilumab 300 mg once weekly (QW) for 4 weeks
Topical Corticosteroid (TCS)
TCS such as methylprednisolone aceponate 0.1%, mometasone furoate 0.1%, or betamethasone valerate 0.1%
Interventions
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Dupilumab
Dupilumab 300 mg once weekly (QW) for 4 weeks
Placebo (for Dupilumab)
Placebo (for Dupilumab) once weekly (QW) for 4 weeks
Topical Corticosteroid (TCS)
TCS such as methylprednisolone aceponate 0.1%, mometasone furoate 0.1%, or betamethasone valerate 0.1%
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Chronic AD that had been present for at least 2 years
Exclusion Criteria
2. Hypersensitivity to corticosteroids or to any other ingredients contained by the TCS product used in the study
3. AD lesions located on face, flexural, and genital areas
4. Certain treatments and medical procedures, undertaken within a particular time frame prior to the baseline visit, preclude eligibility for participation in the study
5. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
6. Treatment with an investigational drug within 8 weeks
7. Known history of human immunodeficiency virus (HIV) infection
8. Presence of certain laboratory abnormalities at the screening visit
9. History of certain opportunistic infections or certain clinical parasite infections
10. History of malignancy within 5 years before the baseline visit, with certain exceptions
11. Pregnant or breast-feeding women
12. Travel within 12 months of study start to areas endemic for parasitic infections, such as developing countries in Africa and the tropical and subtropical regions of Asia
13. History of alcohol or drug abuse within 2 years of the screening visit
14. Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Berlin, , Germany
Dresden, , Germany
Dülmen, , Germany
Frankfurt, , Germany
Gera, , Germany
Langenau, , Germany
Münster, , Germany
Szeged-Hungary, , Hungary
Szolnok, , Hungary
Gdansk, , Poland
Lodz, , Poland
Lublin, , Poland
Warsaw, , Poland
Countries
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References
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Beck LA, Thaci D, Hamilton JD, Graham NM, Bieber T, Rocklin R, Ming JE, Ren H, Kao R, Simpson E, Ardeleanu M, Weinstein SP, Pirozzi G, Guttman-Yassky E, Suarez-Farinas M, Hager MD, Stahl N, Yancopoulos GD, Radin AR. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med. 2014 Jul 10;371(2):130-9. doi: 10.1056/NEJMoa1314768.
Other Identifiers
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R668-AD-1121
Identifier Type: -
Identifier Source: org_study_id