A Phase 3 study of the safety and effectiveness of Apremilast versus placebo in patients with moderate to severe plaque psoriasis
- Conditions
- 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: 19.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2010-019991-55-BE
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 825
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 < 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 upper limit of normal (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 contraception† while on study
medication and for at least 28 days after taking
the last dose of study medication with either: 1) one highly effective form (non-oral hormonal, intrauterine device [IUD], tubal ligation, vasectomized partner); or 2) an oral hormonal contraceptive PLUS one
additional form of barrier contraception (male or female latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane], diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge with spermicide); or 3) two forms of barrier contraception (male or female latex condom or nonlatex condom NOT
made out of natural [animal] membrane [for example, polyurethane]) PLUS one of the following (diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge with spermicide).
Note: The protocol language regarding contraception has been revised. As this study is fully enrolled, the updated language regarding contraception is included in Section 6.2 (Contraception Education) of this
amendment.
† The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal
contraception should be initiated at least 28 days before randomization).
10. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane]) while on study medication and for at 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 740
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85
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 weeks
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method