Psoriasis, a chronic inflammatory skin disorder, estimated to affect up to 2.5% of the world's population. Plaque-type psoriasis is the most common form of this disease. MedDRA version: 18.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Celgene Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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/mm3 (= 3.0 x 109/L) and =65 years) yes F.1.3.1 Number of subjects for this age range 85
Exclusion criteria
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 human immunodeficiency virus (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 intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence) 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 24 hours 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 w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To 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: From Baseline (pre-dose) to Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Major Secondary 1) Proportion of subjects treated with either apremilast 30 mg BID or placebo with a sPGA score of clear (0) or almost clear (1) with at least 2 points reduction from baseline at Week 16 [Time Frame: From Baseline (pre-dose) to Week 16] Efficacy 1) Percent change from Baseline in percent of affected BSA at Week 16 [Time Frame: From Baseline (pre-dose) to Week 16] 2) Percent change in the PASI score from the Baseline Visit at Week 16 [Time Frame: From Baseline (pre-dose) to Week 16] 3) Proportion of subjects who achieve PASI-50 at Week 16 [Time Frame: Week 16] 4) Change from Baseline in Pruritus VAS at Week 16 [Time Frame: From Baseline (pre-dose) to Week 16] 5) Change from baseline in DLQI total score at Week 16 [Time Frame: From baseline (pre-dose) to Week 16] 6) Change from baseline in Mental Component Summary (MCS) score of SF-36 at Week 16 [Time Frame: From Baseline (pre-dose) to Week 16] 7) Proportion of subjects who achieve both PASI-75 and sPGA score of clear (0) or almost clear (1) with at least 2 points reduction from Baseline at Week 16 [Time Frame: From Baseline (pre-dose) to Week 16] 8) Time to loss of PASI-75 response (loss of effect) during the Randomized Treatment Withdrawal Phase [Time Frame: Week 32 until approximately Week 52] Safety Safety as defined by: ?- Type, frequency, severity, seriousness, and relationship of adverse events to apremilast [Time Frame: From the time of Informed Consent, through dosing, and for 28 days after the last dose of study medication.] ?- Number of subjects who prematurely discontinue IP due to an adverse event [Time Frame: From the time of Informed Consent, through dosing, and for 28 days after the last dose of study medication.] ?- Frequency of clinically significant changes in physical examination, vital signs, electrocardiogram, and/or laboratory findings [Time Frame: From the time of Informed Consent, through dosing, and for 28 days after the last dose | — |
Countries
Australia, Belgium, Canada, Germany, Italy, United Kingdom, United States
Contacts
Public ContactClinicalTrialsDisclosure
Celgene Corporation
Outcome results
None listed