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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis

Phase 3
18 Years
Open (Enrolling)
Plaque Psoriasis

Thank you

Trial Information

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis

Inclusion Criteria:

1. Males or females, ≥ 18 years of age at the time of signing the informed consent

2. Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening

a. Have moderate to severe plaque psoriasis at Screening and Baseline

3. Must meet all laboratory criteria

4. Females of childbearing potential (FCBP) must have a negative pregnancy test at
Screening and Baseline. FCBP who engage in activity in which conception is possible
must use 2 forms of contraception as described by the Study Doctor while on study
medication and for at least 28 days after taking the last dose of study medication

5. Male subjects (including those who have had a vasectomy) who engage in activity in
which conception is possible must use barrier contraception (latex condom or any
nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane]) while
on study medication and for a least 28 days after the last dose of study medication.

Exclusion Criteria:

1. Other than psoriasis, history of any clinically significant (as determined by the
Investigator) or other major uncontrolled disease.


2. Pregnant or breast feeding

3. History of allergy to any component of the study drug

4. Hepatitis B surface antigen positive at Screening

5. Anti-hepatitis C antibody positive at Screening

6. Active tuberculosis (TB) or a history of incompletely treated TB

7. Clinically significant abnormality on 12-Lead ECG at Screening

8. Clinically significant abnormal chest x-ray

9. History of positive human immunodeficiency virus (HIV), or have congenital or
acquired immunodeficiency

10. Active substance abuse or a history of substance abuse within 6 months prior to

11. Bacterial infections requiring treatment with oral or injectable antibiotics, or
significant viral or fungal infections, within 4 weeks of Screening

12. Malignancy or history of malignancy (except for treated [ie, cured] basal cell or
squamous cell in situ skin carcinomas and treated [ie, cured] cervical
intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence
of recurrence within the previous 5 years)

13. Psoriasis flare or rebound within 4 weeks prior to Screening

14. Evidence of skin conditions that would interfere with clinical assessments

15. Topical therapy within 2 weeks of randomization

16. Systemic therapy for psoriasis within 4 weeks prior to randomization

17. Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)

18. Adalimumab, etanercept, infliximab, or certolizumab pegol within 12 weeks prior to

19. Alefacept, briakinumab, or ustekinumab within 24 weeks prior to randomization

20. Use of any investigational drug within 4 weeks prior to randomization

21. Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light

22. Prior treatment with apremilast

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Psoriasis Area Severity Index-75 (PASI) score.

Outcome Description:

Proportion of subjects achieving at least a 75% improvement in Psoriasis Area Severity Index score

Outcome Time Frame:

From Baseline (pre-dose) to Week 16

Safety Issue:


Principal Investigator

Irina Khanskaya, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation


Canada: Health Canada

Study ID:




Start Date:

August 2010

Completion Date:

November 2016

Related Keywords:

  • Plaque Psoriasis
  • Plaque Psoriasis
  • Psoriasis



Mount Sinai School of Medicine New York, New York  10029
University Hospitals of Cleveland Cleveland, Ohio  44106
University of Utah Health Sciences Center Salt Lake City, Utah  84132
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania  15213
Oregon Health & Science University Portland, Oregon  97201
Renstar Medical Research Ocala, Florida  34474
International Dermatology Research Miami, Florida  33144
Minnesota Clinical Study Center Fridley, Minnesota  55432
Dawes Fretzin Clinical Research Group, LLC Indianapolis, Indiana  46256
Dermatology Clinical Research Center of San Antonio San Antonio, Texas  78229
Altman Dermatology Associates Arlington Heights, Illinois  60004
Central Dermatology St. Louis, Missouri  63117
Clinical Pharmacology Study Group Worcester, Massachusetts  01610
NorthShore University health system Evanston, Illinois  60201
Oregon Dermatology and Research Center Portland, Oregon  97210
NYU Langone Medical Center New York, New York  10016
Skin Specialists, PC Omaha, Nebraska  
Dermatology Treatment and Research Center Dallas, Texas  75230
Radiant Research, Inc. Greer, South Carolina  29651
Northwest AR Clinical Trials Center, PLLC/ Hull Dermatology, PA Rogers, Arkansas  72758
Associates in Research Inc Fresno, California  93720
Atlanta Dermatology, Vein & Research Center, P.C. Alpharetta, Georgia  30022
Gwinnett Clinical Research Center, Inc. Snellville, Georgia  30078
Dundee Dermatology West Dundee, Illinois  60118
DermResearch, PLLC Louisville, Kentucky  40217
Dermatology & Advanced Aesthetics Lake Charles, Louisiana  70605
ORA Inc. Andover, Massachusetts  04216
Massachusetts General Women's Hospitals Harvard Medical School Boston, Massachusetts  02114-2517
Psoriasis Treatment Center of Central New Jersey East Windsor, New Jersey  08520
UMDNJ Robert Wood Johnson, Medical School Division New Brunswick, New Jersey  08901
DermResearch Center of New York, Inc. Stony Brook, New York  11790
Baker Allergy, Asthma and Dermatology Research Center, LLC Lake Oswego, Oregon  97035
Orgeon Med Research Center, PC Portland, Oregon  97223
Menter Dermatology Reserarch Institute Dallas, Texas  75246