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Phase 1

• Conditions: Psoriasis, a chronic inflammatory skin disorder, estimated to affect up to 2.5% of the world's population. Plaque psoriasis is the most common form of this disease.; MedDRA version: 14.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2010-019991-55-IT
• Lead Sponsor: Celgene Corporation Headquarters

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-20
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 825

Inclusion Criteria

1. Males or females, = 18 years of age at the time of signing the informed consent document 2. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted 3. Able to adhere to the study visit schedule and other protocol requirements 4. Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening 5. Have moderate to severe plaque psoriasis at Screening and Baseline as defined by a. PASI score = 12 and b. BSA = 10%, and c. sPGA = 3 (moderate) 6. Must be a candidate for phototherapy and/or systemic therapy 7. Must be in good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination, 12-lead ECG, clinical laboratories, and urinalysis 8. Must meet the following laboratory criteria a. White blood cell count = 3000/mm^3 (= 3.0 x 10^9/L) and < 14,000/mm^3 (< 14 x 10^9/L) b. Platelet count = 100,000/µL (= 100 x 10^9/L) c. Serum creatinine = 1.5 mg/dL (= 132.6 µmol/L) d. AST (SGOT) and ALT (SGPT) = 2 x ULN e. Total bilirubin = 2 mg/dL (34 µmol/L) f. Hemoglobin = 9 g/dL (= 5.6 mmol/L) g. Hemoglobin A1c = 9.0% 9. 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 while on study medication and for at least 28 days after taking the last dose of study medication: one highly effective form (ie, hormonal, intrauterine device [IUD], tubal ligation, vasectomized partner) and one additional form(latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane], diaphragm, sponge). If one highly effective form of contraception cannot be used, then 2 forms of barrier contraception must be used, ie, latex condom or any nonlatex condom NOT made out of natural (animal) membrane (eg, polyurethane) with either of the following: sponge with spermicide or diaphragm with spermicide. 10. 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Other than psoriasis, history of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease. 2. Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study. 3. Any condition that confounds the ability to interpret data from the study. 4. Pregnant or breast feeding 5. History of allergy to any component of the IP 6. Hepatitis B surface antigen positive at Screening 7. Anti-hepatitis C antibody positive at Screening 8. AST (SGOT) and/or ALT (SGPT) > 1.5 X ULN and total bilirubin > ULN and/or albumin < LLN 9. Active tuberculosis (TB) or a history of incompletely treated TB 10. Clinically significant abnormality on 12-Lead ECG at Screening 11. Clinically significant abnormality based upon chest radiograph with at least PA view (radiograph must be taken within 12 weeks prior to Screening or during the Screening visit). An additional lateral view is strongly recommended but not required. 12. History of positive HIV or have congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease) 13. Active substance abuse or a history of substance abuse within 6 months prior to Screening 14. Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed at least 4 weeks prior to Screening. 15. Malignancy or history of malignancy (except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelialneoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years) 16. Psoriasis flare or rebound within 4 weeks prior to Screening 17. Evidence of skin conditions that would interfere with clinical assessments 18. Topical therapy within 2 weeks of randomization (including but not limited to topical corticosteroids, topical retinoid or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol). Exceptions: low-potency corticosteroids (Class 6 or 7; please refer to the Investigators’ Manual) will be allowed as background therapy for treatment of the face, axillae, and groin in accordance with the manufacturers’ suggested usage during the course of the study. Subjects with scalp psoriasis will be permitted to use coal tar shampoo and/or salicylic acid scalp preparations on scalp lesions. An unmedicated skin moisturizer (eg, Eucerin) will be also permitted for body lesions only. Subjects should not use these topical treatments within 24h prior to the clinic visit. 19. Systemic therapy for psoriasis within 4 weeks prior to randomization (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, fumaric acid esters) 20. Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA) 21. Adalimumab, etanercept, efalizumab, infliximab, or certolizumab pegol within 12 weeks prior to randomization 22. Alefacept, briakinumab, or ustekinumab within 24 weeks prior to randomization 23. Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharm

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the clinical efficacy of apremilast 30 mg BID, compared with placebo, in subjects with moderate to severe plaque psoriasis;Secondary Objective: ? Evaluate the safety and tolerability of apremilast 30 mg BID, compared with placebo, in subjects with moderate to severe plaque psoriasis ? Evaluate the effect of apremilast 30 mg BID compared with placebo on quality of life in subjects with moderate to severe plaque psoriasis;Primary end point(s): Proportion of subjects treated with either apremilast 30 mg BID or placebo who achieve at least a 75% reduction in PASI (PASI-75) at Week 16 from baseline;Timepoint(s) of evaluation of this end point: na

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): na;Timepoint(s) of evaluation of this end point: na