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: Inclusion criteria: 1. Written informed consent, given prior to any study-related procedure not part of the subject’s normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his or her future medical care. 2. Age between 18 and 75 years, inclusive. 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 contraception (i.e. oral contraceptive, condoms or IUD).Confirmation that the subject is not pregnant must be established by a negative urinary hCG test within 7 days prior to 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: Exclusion criteria: 1. Use of more than one NSAID or having a change in 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. 2. Previous systemic treatment with biologics, including interferon and/or 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 any experimental therapeutic procedure considered to interfere with the study within 3 months before SD1 (exceptions to be discussed with Serono). 4. Treatment with any systemic corticosteroids or intra-articular corticosteroid injection during the 28 days before SD1. 5. Any previous treatment with chlorambucil or cyclophosphamide. 6. Treated with cyclosporine or methotrexate or oral retinoids within 28 days prior to SD1. 7. Treatment with topical therapies (vitamin D derivatives, corticosteroids) within 14 days before SD1. 8. Phototherapy within 28 days before 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 valuses, aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase level =1.5 times the upper limit of normal values. 11. Inadequate bone marrow reserve, defined by: · Leucocytes = 3.5 x 109/L, or · 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 virus (HBV) or hepatitis C virus (HCV). 14. Planned major surgery during 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). 16. History of active tuberculosis, current active tuberculosis or current treatment or prophylactic therapy for tuberculosis. 17. Active severe infection (or non-severe infection at the discretion of the Investigator). 18. Opportunistic infection in the 3 months preceding SD1. 19. Clinically significant and serious abnormalities on electrocardiography or chest X-ray (at the discretion of the investigator). 20. Other serious concomitant disorders incompatible with the study. In particular, subjects with congestive heart failure, prior history or current blood dyscrasia or central nervous system demyelinating disorders should not be included in the study. 21. History of or current drug (including narcotics) abuse, or current active problems with alcohol abuse. 22. Requirement for immunisation, allergy desensitisation or vaccination during the entire study period (it is recommended that these are scheduled at least 14 days prior to SD1 or more than 3 months after the last injection of study drug). 23. Guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis. 24. Evidence of skin conditions other than psoriasis (e.g. eczema) that would interfere with psoriasis disease assessments. 25. Clinically significant psoriasis flare during screening or at the time of enrolment necessitating immediate relief (at the Investigator’s discretion). 26. Live or killed virus or bacteria vaccines (within 14 days before SD1). 27. Wheelchair-bound or bedridden status.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the safety and efficacy of maintenance therapy with onercept 150 mg TIW compared to matching placebo in subjects having achieved a PASI 75 response at the end of an initial 12-week induction treatment with onercept 150 mg TIW.;Secondary Objective: The secondary objective of the study is to assess the safety and efficacy of extended therapy with onercept 150 mg TIW compared to matching placebo in subjects that have only achieved a partial response (PASI 50 to 74) after initial 12-week induction course with onercept 150 mg TIW.;Primary end point(s): The primary endpoint of this study is the time to relapse, defined for subjects achieving PASI 75 at Week 12 of the Open Label First Treatment (OLFT) period, to be the loss of at least 50% of the improvement in PASI achieved at Week 12 (OLFT period) with respect to baseline (Study Day 1). | — |
Countries
Denmark, Italy, Spain, Sweden
Outcome results
None listed