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Sponsored by: |
Celgene Corporation |
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Information provided by: | Celgene Corporation |
ClinicalTrials.gov Identifier: | NCT00773734 |
The purpose of this study is to test if the study drug apremilast is safe, if it helps improve psoriasis, and how subjects tolerate it.
Condition | Intervention | Phase |
---|---|---|
Psoriasis Plaque-Type Psoriasis |
Drug: Apremilast 10mg Drug: Apremilast 20mg Drug: Apremilast 30mg Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study) |
Estimated Enrollment: | 348 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Apremilast 10mg: Active Comparator |
Drug: Apremilast 10mg
10mg tablets
|
Apremilast 20mg: Active Comparator |
Drug: Apremilast 20mg
20mg tablets
|
Apremilast 30mg: Active Comparator |
Drug: Apremilast 30mg
30mg tablets
|
Placebo: Placebo Comparator |
Drug: Placebo
Apremilast identically appearing placebo tablets
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of chronic, stable plaque psoriasis at least 6 months prior to screening as defined by:
Exclusion Criteria:
Contact: Dale McElveen | 908-860-7493 | dmcelveen@celgene.com |
Contact: Vilma Hernandez | 908-860-7559 | vhernandez@celgene.com |
United States, California | |
Associates In Research Inc | Recruiting |
Fresno, California, United States, 93720 | |
Contact: Pang Vang 559-432-6457 pang@assoc-in-research.com | |
Principal Investigator: Regina Hamlin, MD | |
United States, Delaware | |
Atlantic Skin & Cosmetic Surgery Group, PC | Recruiting |
Wilmington, Delaware, United States, 19810 | |
Contact: Shannon Denney 302-478-8532 shanld293@aol.com | |
Principal Investigator: Michael Saruk, MD | |
United States, Florida | |
Renstar Medical Research | Recruiting |
Ocala, Florida, United States, 34471 | |
Contact: Mary Standey 352-629-5800 ext 131 mary.standley@renstar.net | |
Principal Investigator: Frederick Behringer, MD | |
United States, Georgia | |
Atlanta Dermatology, Vein & Research Center | Recruiting |
Alpharetta, Georgia, United States, 30022 | |
Contact: Erika Heidl 770-360-8881 erika@dermandvein.com | |
Principal Investigator: Tiffani K Hamilton, MD | |
United States, Indiana | |
Dawes/Fretzin Dermatology Group Inc | Recruiting |
Indianapolis, Indiana, United States, 46256 | |
Contact: Katy Byrd 317-621-7790 ext 123 kbyrd@ecommunity.com | |
Principal Investigator: Scott A Fretzin, MD | |
United States, Louisiana | |
Dermatology & Advanced Aesthetics | Recruiting |
Lake Charles, Louisiana, United States, 70605 | |
Contact: Cindi Reed 337-477-0011 creed@shondrasmithmd.com | |
Principal Investigator: Shondra Smith, MD | |
United States, Minnesota | |
Minnesota Clinical Study Center | Recruiting |
Fridley, Minnesota, United States, 55432 | |
Contact: Dawn Snow 763-571-4200 ext 221 | |
Principal Investigator: Steven E. Kempers, MD | |
United States, Oregon | |
Northwest Cutaneous Research Specialists | Recruiting |
Portland, Oregon, United States, 97210 | |
Contact: Teri Paris 503-226-3376 ext 15 teriparis@verizon.net | |
Principal Investigator: Phoebe Rich, MD | |
United States, Tennessee | |
Rivergate Dermatology Clinical Research | Recruiting |
Goodlettsville, Tennessee, United States, 37072 | |
Contact: Janet Reed 615-859-7546 jreed@rivderm.com | |
Principal Investigator: Keith H Loven, MD | |
United States, Wisconsin | |
Aurora Advanced Healthcare, Inc | Recruiting |
Milwaukee, Wisconsin, United States, 53209 | |
Contact: Carrie Ceman 414-352-5161 ext 4690 | |
Principal Investigator: Eugene Monroe, MD |
Responsible Party: | Celgene Corporation ( Yong Lin, MD ) |
Study ID Numbers: | CC-10004-PSOR-005 |
Study First Received: | October 14, 2008 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00773734 |
Health Authority: | United States: Food and Drug Administration |
moderate-to-severe plaque-type psoriasis |
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |