Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Dermatitis, Atopic Dermatitis

In brief

A study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe atopic dermatitis

Key facts

Study ID

NCT02087943

Run by

Amgen

People needed

191

Starts

2014-06-01

Expected to finish

2016-02-01

Last updated by the study team

2020-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females, aged ≥ 18 years (≥ 20 for Japanese subjects) at the time of consent.
• Have a diagnosis of atopic dermatitis for ≥ 12 months.
• Have moderate to severe atopic dermatitis which is considered inappropriate for topical therapy or which cannot be adequately controlled by topical therapy.
• Meet the laboratory criteria as defined per protocol
• 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
• 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.

You may not qualify if…

• Active tuberculosis (TB) or a history of inadequately treated tuberculosis.
• Positive for hepatitis B surface antigen or hepatitis C antibody
• Pregnant or breast feeding
• History of allergy to any component of the study medication.
• Active skin infection requiring systemic antimicrobials at Baseline.

Where it is running

• 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

Full record on ClinicalTrials.gov

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