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)
Sponsor study identifier
interventional
352
2 countries
35
Study Start
September 1, 2008
Actual (reported)Primary Completion
August 1, 2009
Actual (reported)Study Completion
May 20, 2015
Actual (reported)The purpose of this study was to test if the drug apremilast was safe, if it helped improve psoriasis, and how well the participants tolerated it.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 20, 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2008
Actual (reported)October 14, 2008
Actual (reported)October 16, 2008
Actual (reported)August 1, 2009
Actual (reported)November 13, 2014
Actual (reported)May 20, 2015
Actual (reported)Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in Psoriasis Area and Severity Index (PASI) at Week 16
PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).
Week 0 and Week 16
Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in PASI Score at Week 24
Week 0 to Week 24
Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in PASI Score at Week 16
Week 0 to Week 16
Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 24
Week 0 to Week 24
Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) From Baseline in the PASI Score at Week 16
Week 0 to Week 16
Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 24
Week 0 to Week 24
Core Study: Percentage of Participants With a Static Physician Global Assessment (sPGA) Greater Than 2 at Baseline Who Achieved a Score of 0 or 1 at Week 16
Week 0 to Week 16
Core Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 24
Week 0 and Week 24
Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 32
Week 0 to Week 32
Apremilast 10 mg administered orally twice daily (BID) for 16 weeks (following dose titration) during the placebo controlled phase followed by 10 mg Apremilast tablets orally administered BID for 8 weeks in the active treatment phase
Apremilast 20 mg administered orally twice daily (BID) for 16 weeks (following dose titration) during the placebo controlled phase followed by 20 mg Apremilast tablets orally administered BID for 8 weeks in the active treatment phase
Associates In Research Inc
Fresno, California, 93720, United States
Dermatology Associates
Los Angeles, California, 90045, United States
Stanford University School of Medicine
Redwood City, California, 94063, United States
Atlantic Skin & Cosmetic Surgery Group, PC
Wilmington, Delaware, 19810, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Atlanta Dermatology, Vein & Research Center
Alpharetta, Georgia, 30022, United States
NorthShore University HealthSystem
Papp K, Cather JC, Rosoph L, Sofen H, Langley RG, Matheson RT, Hu C, Day RM. Efficacy of apremilast in the treatment of moderate to severe psoriasis: a randomised controlled trial. Lancet. 2012 Aug 25;380(9843):738-46. doi: 10.1016/S0140-6736(12)60642-4. Epub 2012 Jun 29.
Ohtsuki M, Kubo H, Morishima H, Goto R, Zheng R, Nakagawa H. Guselkumab, an anti-interleukin-23 monoclonal antibody, for the treatment of moderate to severe plaque-type psoriasis in Japanese patients: Efficacy and safety results from a phase 3, randomized, double-blind, placebo-controlled study. J Dermatol. 2018 Sep;45(9):1053-1062. doi: 10.1111/1346-8138.14504. Epub 2018 Jun 15.
MD
Amgen
352 participants (actual enrollment reported by the registry).
First Submitted
October 14, 2008
First Posted
October 16, 2008
Study Start
September 1, 2008
Actual (reported)Apremilast 30 mg administered orally twice daily (BID) for 16 weeks (following dose titration) during the placebo controlled phase followed by 30 mg Apremilast tablets orally administered BID for 8 weeks in the active treatment phase
Oral Placebo tablets administered twice daily (BID) for 16 weeks during the placebo-controlled phase.
Participants initially randomized to receive placebo twice daily during the 16 week placebo controlled phase are re-randomized to 20 mg apremilast BID during the 8 week active treatment phase
Participants initially randomized to receive placebo twice daily during the 16 week placebo controlled phase are re-randomized to 30 mg apremilast BID during the 8 week active treatment phase
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Skokie, Illinois, 60077, United States
Dawes/Fretzin Dermatology Group Inc
Indianapolis, Indiana, 46256, United States
Dermatology & Advanced Aesthetics
Lake Charles, Louisiana, 70605, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Central Dermatology
St Louis, Missouri, 63117, United States
UMDNJ Robert Wood Johnson
New Brunswick, New Jersey, 08901, United States
Wright State University
Dayton, Ohio, 45408, United States
Allergy, Asthma and Dermatology Research Center
Lake Oswego, Oregon, 97035, United States
Northwest Cutaneous Research Specialists
Portland, Oregon, 97210, United States
Oregon Med. Research Center, PC
Portland, Oregon, 97223, United States
Rivergate Dermatology Clinical Research
Goodlettsville, Tennessee, 37072, United States
Modern Research Associates
Dallas, Texas, 75231, United States
Dermatology Associates of Seattle
Seattle, Washington, 98101, United States
Aurora Advanced Healthcare, Inc
Milwaukee, Wisconsin, 53209, United States
Stratica Medical
Edmonton, Alberta, T5K 1X3, Canada
Dr. Lorne E. Albrecht
Surrey, British Columbia, V3R 6A7, Canada
Alpha Clinical Research Centre
St. John's, Newfoundland and Labrador, A1B 4S8, Canada
Eastern Canada Cutaneous Research Associates
Halifax, Nova Scotia, B3H 1Z4, Canada
Ultranova Skincare
Barrie, Ontario, L4M 6L2, Canada
Dermatrials Research Division
Hamilton, Ontario, L8N 1V6, Canada
Guenther Dermatology Research Centre
London, Ontario, N6A 3H7, Canada
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7, Canada
Dr. Michael Robern
Ottawa, Ontario, K2G 6E2, Canada
K. Papp Clinical Research Inc.
Waterloo, Ontario, N2J 1C4, Canada
XLR8 Research
Windsor, Ontario, N8W 1E6, Canada
Innovaderm Research Laval Inc.
Laval, Quebec, H7S 2C6, Canada
Centre De Recherche Dermatologique du Qu
MetSte-Foy, Quebec, G1V 4X7, Canada
Innovaderm Research Inc.
Montreal, Quebec, H2K 4L5, Canada
International Dermatology Research, Inc.
Montreal, Quebec, H3H 1V4, Canada
Knuckles MLF, Levi E, Soung J. Defining and treating moderate plaque psoriasis: a dermatologist survey. J Dermatolog Treat. 2018 Nov;29(7):658-663. doi: 10.1080/09546634.2018.1443200. Epub 2018 Mar 22.
Knuckles MLF, Levi E, Soung J. Treating moderate plaque psoriasis: prospective 6-month chart review of patients treated with apremilast. J Dermatolog Treat. 2019 Aug;30(5):430-434. doi: 10.1080/09546634.2018.1528326. Epub 2018 Nov 26.
Wu JJ, Pelletier C, Ung B, Tian M. Real-world treatment patterns and healthcare costs among biologic-naive patients initiating apremilast or biologics for the treatment of psoriasis. J Med Econ. 2019 Apr;22(4):365-371. doi: 10.1080/13696998.2019.1571500. Epub 2019 Feb 4.
Wang Y, Coyne K, Sofen H, Santanello N, Currie B, Zhang Z, Nograles K. Qualitative analysis and reproducibility assessment of the Scalp Itch Numeric Rating Scale among patients with moderate to severe plaque psoriasis of the scalp. J Dermatolog Treat. 2019 Dec;30(8):775-783. doi: 10.1080/09546634.2019.1577546. Epub 2019 Mar 5.
Strand V, Fiorentino D, Hu C, Day RM, Stevens RM, Papp KA. Improvements in patient-reported outcomes with apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of moderate to severe psoriasis: results from a phase IIb randomized, controlled study. Health Qual Life Outcomes. 2013 May 10;11:82. doi: 10.1186/1477-7525-11-82.
Mease PJ, Hatemi G, Paris M, Cheng S, Maes P, Zhang W, Shi R, Flower A, Picard H, Stein Gold L. Apremilast Long-Term Safety Up to 5 Years from 15 Pooled Randomized, Placebo-Controlled Studies of Psoriasis, Psoriatic Arthritis, and Behcet's Syndrome. Am J Clin Dermatol. 2023 Sep;24(5):809-820. doi: 10.1007/s40257-023-00783-7. Epub 2023 Jun 14.
Primary Completion
August 1, 2009
Actual (reported)Study Completion
May 20, 2015
Actual (reported)Last Updated
May 7, 2020
Results First Posted
November 13, 2014
Record last verified: 2020-04
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Source: ClinicalTrials.gov.
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