Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis
NCT ID: NCT02087943
Last Updated: 2020-05-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
191 participants
INTERVENTIONAL
2014-06-30
2016-02-29
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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Apremilast 40 mg
Apremilast 40 mg administered orally twice daily (BID) for 12 weeks (following dose titration) during the placebo controlled phase followed by 40 mg Apremilast tablets orally administered BID for an additional 12 weeks in the active treatment phase
Apremilast
Orally twice a day (BID)
Apremilast 30 mg
Apremilast 30 mg administered orally BID for 12 weeks (following dose titration) during the placebo controlled phase followed by 30 mg Apremilast tablets orally administered BID for an additional 12 weeks in the active treatment phase
Apremilast
Orally twice a day (BID)
Placebo + Apremilast 40 mg
Placebo administered orally BID for 12 weeks, during the placebo controlled phase followed by 40 mg Apremilast tablets orally BID for an additional 12 weeks in the active treatment phase
Apremilast
Orally twice a day (BID)
Placebo
Orally twice a day (BID)
Placebo + Apremilast 30 mg
Placebo administered orally BID for 12 weeks, during the placebo controlled phase followed by 30 mg Apremilast tablets orally BID for an additional 12 weeks in the active treatment phase
Apremilast
Orally twice a day (BID)
Placebo
Orally twice a day (BID)
Placebo
Oral Placebo tablets administered twice daily (BID) for 12 weeks during the placebo-controlled phase.
Placebo
Orally twice a day (BID)
Interventions
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Apremilast
Orally twice a day (BID)
Apremilast
Orally twice a day (BID)
Placebo
Orally twice a day (BID)
Placebo
Orally twice a day (BID)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have a diagnosis of atopic dermatitis for ≥ 12 months.
3. Have moderate to severe atopic dermatitis which is considered inappropriate for topical therapy or which cannot be adequately controlled by topical therapy.
4. Meet the laboratory criteria as defined per protocol
5. Females of Childbearing Potential (FCBP) must have a negative pregnancy test at Screening and Baseline. Sexually active FCBP must use one of the approved contraceptive options required per protocol while on and for at least 28 days after the last dose of study medication
6. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception while on and for at least 28 days after the last dose of study medication.
Exclusion Criteria
2. Positive for hepatitis B surface antigen or hepatitis C antibody
3. Pregnant or breast feeding
4. History of allergy to any component of the study medication.
5. Active skin infection requiring systemic antimicrobials at Baseline.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Arizona Research Center
Phoenix, Arizona, United States
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Renstar Medical Research
Ocala, Florida, United States
Emory Clinic
Atlanta, Georgia, United States
Advanced Medical Research
Atlanta, Georgia, United States
Northwestern University Northwestern Medical Faculty Foundation
Chicago, Illinois, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States
Dermatology Specialists, PSC
Louisville, Kentucky, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
NYU Department of Dermatology
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
PMG Research of Winston-Salem LLC
Winston-Salem, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Virginia Clinical Research Inc
Norfolk, Virginia, United States
Chih-Ho Hong Medical, Inc.
Surrey, British Columbia, Canada
Eastern Canada Cutaneous Research Associates Ltd
Halifax, Nova Scotia, Canada
Ultranova Skincare
Barrie, Ontario, Canada
K. Papp Clinical Research
Waterloo, Ontario, Canada
Innovaderm Research
Montreal, Quebec, Canada
Centre Dermatologique du Quebec Metropolitain
Ste-Foy, Quebec, Canada
Kokubu Abashiri Dermatology Clinic
Abashiri-shi, Hokkaido, , Japan
Asanuma Dermatology Clinic
Chitose-shi, Hokkaido, , Japan
Fukuoka University Hospital Dermatology
Fukuoka-shi, Fukuoka, , Japan
Hatamoto Dermatology Clinic
Fukuoka-shi, Fukuoka, , Japan
Tashiro Clinic
Iizuka-shi, Fukuoka, , Japan
Kokubu Dermatology
Kitami-shi, Hokkaido, , Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, , Japan
Kyoto University Hospital
Kyoto, , Japan
Sapporo Skin Clinic
Sapporo-shi, Hokkaido, , Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, , Japan
Countries
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References
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Simpson EL, Imafuku S, Poulin Y, Ungar B, Zhou L, Malik K, Wen HC, Xu H, Estrada YD, Peng X, Chen M, Shah N, Suarez-Farinas M, Pavel AB, Nograles K, Guttman-Yassky E. A Phase 2 Randomized Trial of Apremilast in Patients with Atopic Dermatitis. J Invest Dermatol. 2019 May;139(5):1063-1072. doi: 10.1016/j.jid.2018.10.043. Epub 2018 Dec 5.
Other Identifiers
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CC-10004-AD-001
Identifier Type: -
Identifier Source: org_study_id
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