Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)

NCT00773734 | Completed Phase 2 Results DMC

• 1 other identifier: CC-10004-PSOR-005
• Study Type: interventional
• Target: 352
• Locations: 2 countries
• Sites: 35

Brief Summary

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.

Conditions

Psoriasis; Plaque-type Psoriasis

Keywords

moderate-to-severe plaque-type psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (107)

• 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

Other Outcomes (9)

• 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

Study Arms (6)

Apremilast 10mg

EXPERIMENTAL

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

Drug: Apremilast 10mg

Apremilast 20mg

EXPERIMENTAL

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

Drug: Apremilast 20mg

Apremilast 30 mg

EXPERIMENTAL

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

Drug: Apremilast 30 mg

Placebo

PLACEBO COMPARATOR

Oral Placebo tablets administered twice daily (BID) for 16 weeks during the placebo-controlled phase.

Drug: Placebo

Placebo/Apremilast 20 mg

EXPERIMENTAL

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

Drug: Apremilast 20mg

Placebo/Apremilast 30mg

EXPERIMENTAL

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

Drug: Apremilast 30mg

Interventions

Apremilast 10mg DRUG

Also known as: Apremilast tablets, CC-10004, Otezla

Apremilast 10mg

Apremilast 20mg DRUG

Also known as: Apremilast tablets, CC-10004, Otezla

Apremilast 20mg

Apremilast 30 mg DRUG

Also known as: Apremilast tablets, CC-10004, Otezla

Apremilast 30 mg

Placebo DRUG

Placebo

Apremilast 30mg DRUG

Also known as: Apremilast tablets, CC-10004, Otezla

Placebo/Apremilast 30mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and voluntarily sign an informed consent form
• ≥18 years of age at the time of signing the informed consent form
• Able to adhere to the study visit schedule and other protocol requirements.
• Diagnosis of chronic, stable plaque psoriasis at least 6 months prior to screening as defined by:
• PASI (Psoriasis Area and Severity Index) score ≥ 12
• Body Surface Area (BSA) ≥ 10%
• Candidate for photo/systemic therapy
• In good health as judged by the investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry, hematology, immunology, and urinalysis
• Meet all laboratory criteria as defined per protocol
• Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception methods. A FCBP must agree to have pregnancy tests every 4 weeks while on study medication
• Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP while on study medication and for 84 days after taking the last dose of study medication

You may not qualify if:

• History of clinically significant disease (as determined by the investigator)
• Pregnant or breastfeeding
• History of active mycobacterial infection within 3 years
• History of Human Immunodeficiency Virus (HIV) infection
• Congenital and acquired immunodeficiencies
• Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening
• Antibodies to Hepatitis C at screening
• Malignancy or history of malignancy except for treated \[i.e., cured\] basal-cell skin carcinomas
• Any condition, including the presence of laboratory abnormalities, that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
• Psoriasis flare within 4 weeks of screening
• Topical therapy within 2 weeks of randomization
• Systemic therapy for psoriasis within 4 weeks of randomization
• Use of phototherapy within 4 weeks of randomization \[(i.e., Ultraviolet (UVB), Psoralens and long-wave ultraviolet radiation (PUVA)\]
• Adalimumab, etanercept, efalizumab or infliximab within 12 weeks of randomization
• Alefacept within 24 weeks of randomization

Sponsors & Collaborators

• Amgen: lead

Study Sites (35)

Associates In Research Inc

Fresno, California, 93720, United States

Location

Dermatology Associates

Los Angeles, California, 90045, United States

Location

Stanford University School of Medicine

Redwood City, California, 94063, United States

Location

Atlantic Skin & Cosmetic Surgery Group, PC

Wilmington, Delaware, 19810, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Atlanta Dermatology, Vein & Research Center

Alpharetta, Georgia, 30022, United States

Location

NorthShore University HealthSystem

Skokie, Illinois, 60077, United States

Location

Dawes/Fretzin Dermatology Group Inc

Indianapolis, Indiana, 46256, United States

Location

Dermatology & Advanced Aesthetics

Lake Charles, Louisiana, 70605, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Central Dermatology

St Louis, Missouri, 63117, United States

Location

UMDNJ Robert Wood Johnson

New Brunswick, New Jersey, 08901, United States

Location

Wright State University

Dayton, Ohio, 45408, United States

Location

Allergy, Asthma and Dermatology Research Center

Lake Oswego, Oregon, 97035, United States

Location

Northwest Cutaneous Research Specialists

Portland, Oregon, 97210, United States

Location

Oregon Med. Research Center, PC

Portland, Oregon, 97223, United States

Location

Rivergate Dermatology Clinical Research

Goodlettsville, Tennessee, 37072, United States

Location

Modern Research Associates

Dallas, Texas, 75231, United States

Location

Dermatology Associates of Seattle

Seattle, Washington, 98101, United States

Location

Aurora Advanced Healthcare, Inc

Milwaukee, Wisconsin, 53209, United States

Location

Stratica Medical

Edmonton, Alberta, T5K 1X3, Canada

Location

Dr. Lorne E. Albrecht

Surrey, British Columbia, V3R 6A7, Canada

Location

Alpha Clinical Research Centre

St. John's, Newfoundland and Labrador, A1B 4S8, Canada

Location

Eastern Canada Cutaneous Research Associates

Halifax, Nova Scotia, B3H 1Z4, Canada

Location

Ultranova Skincare

Barrie, Ontario, L4M 6L2, Canada

Location

Dermatrials Research Division

Hamilton, Ontario, L8N 1V6, Canada

Location

Guenther Dermatology Research Centre

London, Ontario, N6A 3H7, Canada

Location

North Bay Dermatology Centre

North Bay, Ontario, P1B 3Z7, Canada

Location

Dr. Michael Robern

Ottawa, Ontario, K2G 6E2, Canada

Location

K. Papp Clinical Research Inc.

Waterloo, Ontario, N2J 1C4, Canada

Location

XLR8 Research

Windsor, Ontario, N8W 1E6, Canada

Location

Innovaderm Research Laval Inc.

Laval, Quebec, H7S 2C6, Canada

Location

Centre De Recherche Dermatologique du Qu

MetSte-Foy, Quebec, G1V 4X7, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

International Dermatology Research, Inc.

Montreal, Quebec, H3H 1V4, Canada

Location

Related Publications (8)

• 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.

  PMID: 22748702 BACKGROUND

• 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.

  PMID: 29905383 BACKGROUND

• 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.

  PMID: 29502473 BACKGROUND

• 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.

  PMID: 30339049 BACKGROUND

• 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.

  PMID: 30652520 BACKGROUND

• 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.

  PMID: 30747550 BACKGROUND

• 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.

  PMID: 23663752 RESULT

• 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.

  PMID: 37316690 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Anne McClain
• Organization: Celgene Corporation

clinicaltrialdisclosure@celgene.com

888-243-1360

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2008
• First Posted: October 16, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: May 20, 2015
• Last Updated: May 7, 2020
• Results First Posted: November 13, 2014

Record last verified: 2020-04

Locations

US (20); CA (15)