Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis



Status:Active, not recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2010
End Date:October 2016

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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

This study evaluated the effects of an called apremilast. Apremilast works by lowering some
of the chemicals that affect psoriasis and therefore improves the symptoms of psoriasis. The
purpose of this study was to test apremilast and compare its effects to placebo (an inactive
substance which contains no medicine but is in the same form as the drug). This study was
able to test for efficacy (improvement of signs and symptoms) and safety of apremilast in
patients with moderate to severe psoriasis.


Inclusion Criteria:

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

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 Electrocardiogram (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
Screening

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, Ultraviolet B (UVB),
psoralen and ultraviolet A (PUVA)

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

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
sources

22. Prior treatment with apremilast
We found this trial at
36
sites
Salt Lake City, Utah 84132
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59 One Mile Road
East Windsor, New Jersey 08520
609-443-4500
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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7810 Louis Pasteur
San Antonio, Texas 78229
210-692-1382
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Alpharetta, Georgia 30022
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Andover, Massachusetts 01810
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Arlington Heights, Illinois 60005
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
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Dallas, TX
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Fresno, California 93720
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Fridley, Minnesota 55432
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Greer, South Carolina
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Houston, Texas 77030
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Indianapolis, Indiana 46256
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Kogarah, New South Wales 2217
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Lake Charles, Louisiana 70605
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Louisville, Kentucky 40217
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New York, New York 10016
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Omaha, Nebraska 68144
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Portland, Oregon 97210
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Portland, Oregon 97223
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Rogers, AR
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Skokie, Illinois 60076
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Snellville, Georgia 30078
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St. Loius, Missouri 63117
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Stony Brook, New York 11790
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West Dundee, Illinois 60118
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Worcester, Massachusetts 01610
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