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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:

Proportion of subjects who achieve at least a 75% reduction in Psoriasis Area Severity Index (PASI-75) at Week 16 from baseline.

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:

November 2010

Completion Date:

December 2016

Related Keywords:

  • Plaque Psoriasis
  • Psoriasis



Northwestern UniversityChicago, Illinois  60611
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
Piedmont Medical Research AssociatesWinston Salem, North Carolina  27103
Center For Clinical StudiesHouston, Texas  77030
Clinical Partners, LLCJohnston, Rhode Island  02919
Radiant ResearchGreer, South Carolina  29651
Arizona Research CenterPhoenix, Arizona  85023
Virginia Clinical Research, Inc.Norfolk, Virginia  23507
Medaphase, Inc710 Newnan Crossing Bypass, Suite B Newnan, Georgia  30263
Florida Academic Dermatology CentersMiami, Florida  33136
Dermatology Research AssociatesLos Angeles, California  90045
Peachtree Dermatology Associates, PCAtlanta, Georgia  30327
Burke Pahrmaceutical ResearchHot Springs, Arkansas  71913
Bakersfield Dermatology and Skin Cancer Medical CenterBakersfield, California  93309
Clinical Science InstituteSanta Monica, California  90404
Tufts-New England Medical Center HospitalsBoston, Massachusetts  02111
Austin Dermatology AssociatesAustin, Texas  78705
Modern Research AssociatesDallas, Texas  75231