Status:
COMPLETED
Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis.
Lead Sponsor:
Amgen
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the effects of an experimental (being tested) study drug called apremilast. Apremilast works by lowering some of the chemicals that affect psoriasis and therefore improves the...
Eligibility Criteria
Inclusion
- Males or females, ≥ 18 years of age at the time of signing the informed consent document
- Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening
- a. Have moderate to severe plaque psoriasis at Screening and Baseline
- Must meet all laboratory criteria
- 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
- 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
- Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease.
- Pregnant or breast feeding
- History of allergy to any component of the study drug
- Hepatitis B surface antigen positive at Screening
- Anti-hepatitis C antibody positive at Screening
- Active tuberculosis (TB) or a history of incompletely treated TB
- Clinically significant abnormality on 12-Lead ECG at Screening
- Clinically significant abnormal chest x-ray
- History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency
- Active substance abuse or a history of substance abuse within 6 months prior to Screening
- Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening
- 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)
- Psoriasis flare or rebound within 4 weeks prior to Screening
- Evidence of skin conditions that would interfere with clinical assessments
- Topical therapy within 2 weeks of randomization
- Systemic therapy for psoriasis within 4 weeks prior to randomization
- Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)
- Adalimumab, etanercept, infliximab, or certolizumab pegol within 12 weeks prior to randomization
- Alefacept, briakinumab, or ustekinumab within 24 weeks prior to randomization
- Use of any investigational drug within 4 weeks prior to randomization
- Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
- Prior treatment with apremilast
Key Trial Info
Start Date :
November 22 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2016
Estimated Enrollment :
413 Patients enrolled
Trial Details
Trial ID
NCT01232283
Start Date
November 22 2010
End Date
November 30 2016
Last Update
March 15 2022
Active Locations (46)
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1
Arizona Skin and Laser Therapy Inst., Ltd.
Phoenix, Arizona, United States, 85023
2
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
3
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, United States, 93309
4
Dermatology Research Associates
Los Angeles, California, United States, 90045