Psoriasis is an inflammatory skin disorder that affects between 1 and 2% of the population. It is characterised by an increased proliferation of the epidermis, and presents as well-defined thickened erythematous patches typically covered with a silver scale. MedDRA version: 7.0 Level: PT Classification code 10037153
Conditions
Sponsors
Serono International S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent, given before any study-related procedure not part of the subject’s normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his or her future medical care. 2. At least 18 years of age. 3. Female subjects must be neither pregnant nor breast-feeding, and must lack childbearing potential, as defined by either:· Being post-menopausal (i.e. at least 12 months past last menses) or surgically sterile, or Using an effective form of contraception (i.e. condoms, oral contraceptives or IUD). Confirmation that the subject is not pregnant must be established by a negative urinary hCG test within 7 days before Study Day 1 (SD1). A pregnancy test is not required if the subject is post-menopausal or surgically sterile. 4. Outpatient status at the time of enrolment. 5. Plaque psoriasis for at least 12 months. 6. Plaque psoriasis covering at least 10% of total body surface area and a PASI score of 12.0 or more. 7. Candidacy for phototherapy or systemic therapy. 8. Static PGA of 3 or more. Are the trial subjects under 18? no Number of subjects for this age range: 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
Exclusion criteria: 1. Use of more than one NSAID to treat psoriatic arthritis or having a change in chronic NSAID regimen during the 28 days before SD1. Note for guidance: subjects with psoriatic arthritis who are not expected to be controlled by one stable NSAID regimen throughout the entire duration of the study should not be included. Clarification: see amendment 2 2. Previous systemic treatment with biologics, including interferon and other cytokines/anti?cytokines (e.g. anti-TNF-alpha, anti-CD4, IL-10, IL-1ra, anti-CD11a) within 3 months before SD1 3. Participation in any other investigational study or experimental therapeutic procedure that is considered to interfere with the study within 3 months before SD1. Clarification: see amendment 2 4. Treated with any systemic corticosteroids or intra-articular corticosteroid injection during the 28 days prior to SD1 5. Experimental or off-label treatments for psoriasis and/or psoriatic arthritis, such as azathioprine, hydroxyurea/hydroxycarbamide, mycophenolate, chlorambucil, leflunomide or cyclophosphamide, within 1 year prior to SD1 6. Treatment with cyclosporin, methotrexate, oral retinoids retinoids (i.e acetretin), or fumaric acid esters within 28 days (3 months for acetretin) before SD1 7. Treatment with any topical therapies, such as vitamin D derivatives, corticosteroids, tars and tar oils, dithranol for chronic or short contact therapy, salicylic acid and topical retinoids, within 14 days before SD1 8. Phototherapy within 28 days prior to SD1 9. Use of tanning booths within 14 days before SD1 10. Abnormal liver function, defined by a total bilirubin = 1.2 times the upper limit of normal values (except in case of Gilbert’s syndrome), or aspartate aminotransferase, alanine aminotransferase or total alkaline phosphatase levels = 2.5 times the upper limit of normal values 11. Inadequate bone marrow reserve, defined by Leucocytes =3.5 x 109/L, thrombocytes =100 x 109/L, or Haemoglobin =5.5 mmol/L (8.9 g/dL) 12. Abnormal renal function, defined by serum creatinine >150 micromol/L 13. Seropositivity for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) Clarification: see amendment 2 14. Planned major surgery within the treatment period of the study 15. History of cancer in the preceding 5 years (except adequately treated basal cell carcinoma of the skin or squamous cell carcinoma in situ of the skin). Any history of hematopoietic cancer 16. History of active tuberculosis, current active tuberculosis or candidacy for prophylactic therapy for tuberculosis (see Appendix I for guidance on PPD testing, chest X-ray screening and evaluation of patients at high risk for tuberculosis) 17. Active severe infection (or non-severe infection at the discretion of the Investigator) 18. History of any opportunistic infection (e.g., viral, fungal, protozoal, or bacterial) in the 6 months preceding SD1 related to any clinical condition of immunodeficiency 19. Clinically significant and serious abnormalities on electrocardiography or chest X-ray (at the investigator’s discretion) 20. Other serious concomitant disorders incompatible with the study. In particular, subjects with congestive heart failure, prior or current history of blood dyscrasia or central nervous system demyelinating disorders should not be included in the study 21. History of drug (including narcotics) abuse, or current active problems with alcohol abuse 22. Requirement for immunisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the safety and efficacy of an initial 12-week treatment course with onercept 150 mg TIW for the induction of remission in patients with moderate to severe psoriasis, compared to matching placebo.;Secondary Objective: The secondary objectives are to assess the safety of continued therapy with onercept for 28 weeks in patients having received an initial 12-week treatment course with onercept 150 mg TIW or placebo and to assess the safety and efficacy of withdrawal of therapy after 28-40 weeks continuous treatment by comparing onercept 150 mg TIW with matching placebo during a 12-week placebo controlled randomised withdrawal period.;Primary end point(s): The primary endpoint is the proportion of subjects with at least a 75% improvement in the Psoriatic Area and Severity Index (PASI) score between baseline (Study Day 1) and week 12 of the First Treatment period (PT). | — |
Countries
Estonia, Latvia, Lithuania
Outcome results
None listed