Loading clinical trials...
Loading clinical trials...
A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Mild to Moderate Plaque Psoriasis
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to moderate plaque psoriasis. Approximately 574 subjects with mild to moderate plaque psoriasis will be randomized 1:1 to receive either apremilast 30 mg 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 be randomly assigned to either 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 will be switched to (or continue with) apremilast 30 mg BID. All subjects will maintain this dosing through Week 32. * Observational Follow-up Phase - 4 weeks - Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue the study early.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Total Skin & Beauty Dermatology Center
Birmingham, Alabama, United States
Johnson Dermatology Clinic
Fort Smith, Arkansas, United States
Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology
Rogers, Arkansas, United States
Dermatology Research Associates
Los Angeles, California, United States
TCR Medical Corporation
San Diego, California, United States
University of California San Francisco Psoriasis and Skin Treatment Center
San Francisco, California, United States
Clinical Science Institute
Santa Monica, California, United States
University of Colorado Hospital - Dermatology Clinic
Aurora, Colorado, United States
Total Vein and Skin, LLC
Boynton Beach, Florida, United States
Florida Academic Centers Research and Education
Coral Gables, Florida, United States
Start Date
March 11, 2019
Primary Completion Date
March 6, 2020
Completion Date
July 24, 2020
Last Updated
May 29, 2024
595
ACTUAL participants
Apremilast
DRUG
Placebo
OTHER
Lead Sponsor
Amgen
NCT07449234
NCT07116967
NCT07250802
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions