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A Phase 3, Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis of the scalp. Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be randomized 2:1 to receive either apremilast 30 mg twice daily (BID) or placebo for the first 16 weeks.
The study will consist of four phases: * Screening Phase - up to 35 days * Double-blind Placebo-controlled Phase- Weeks 0 to 16 Subjects will receive treatment with one of the following: * apremilast 30 mg tablets orally BID or * placebo tablets (identical in appearance to apremilast 30 mg tablets) orally BID * Apremilast Extension Phase - Weeks 16 to 32 * All subjects who had received placebo during the placebo-controlled phase will be switched to apremilast 30 mg BID (or continue with) apremilast. At Week 16, all subjects will maintain this dosing through Week 32. * Observational Follow-up Phase * Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue from the study early.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology
Rogers, Arkansas, United States
Tien Q. Nguyen MD Inc
Fountain Valley, California, United States
Dermatology Research Associates
Los Angeles, California, United States
San Luis Dermatology and Laser Clinic
San Luis Obispo, California, United States
University of Connecticut
Farmington, Connecticut, United States
Florida Academic Centers Research and Education
Coral Gables, Florida, United States
International Dermatology Research
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Dermatologic Surgery Specialists, P.C.
Macon, Georgia, United States
MedaPhase INC
Newnan, Georgia, United States
Start Date
May 16, 2017
Primary Completion Date
August 13, 2018
Completion Date
January 9, 2019
Last Updated
May 13, 2020
303
ACTUAL participants
Apremilast
DRUG
Placebo
OTHER
Lead Sponsor
Amgen
NCT07449234
NCT07116967
NCT07250802
Data Source & Attribution
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