A multicentre, randomised, double blind, placebo controlled phase III study of subcutaneously administered onercept in the initial treatment and continued treatment after extended therapy in subjects with moderate to severe plaque psoriasis. - N/A

• Conditions: 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: 7.0Level: PTClassification code 10037153

• Registration Number: EUCTR2004-000530-37-EE
• Lead Sponsor: Serono International S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 460

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any study-related procedure not part of the subject’s normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his or her future medical care.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

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: After SD1, use of short courses of NSAIDs or opioids (for less than 28 days) is allowed to treat adverse events.

2. No change. Same as in original application form.

3. Participation in any other investigational study or experimental therapeutic procedure that is considered to interfere with the study within 3 months before
SD 1.
Clarification: For investigational medicinal products, the 3-month period prior to SD 1 is calculated from the last dose received. This period can be reduced if the previous treatment is not considered to interfere with participation in this study, e.g. topical treatments for psoriasis and/or if time between last dose received is more than 5 times the half life of the IMP received. However, if the subject is still in the follow-up period of another study, participation in this study is not allowed.

4. No change. Same as in original application form.

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 SD 1.

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 SD 1.

8. No change. Same as in original application form.

9. No change. Same as in original application form.

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. No change. Same as in original application form.

12. No change. Same as in original application form.

13. Seropositivity for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
Clarification: Subjects previously vaccinated for hepatitis B are allowed into this study. Testing for hepatitis B seropositivity as the eligibility criterion for this study is related to hepatitis B surface antigen (HBsAg) results.

14. No change. Same as in original application form.

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. No change. Same as in original application form.

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. No change. Same as in original application form.

20. No change. Same as in

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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).