A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy,safety and tolerability of two doses of ACT-128800, an oral S1P1 receptor agonist, administered up totwenty-eight weeks in patients with moderate to severe chronic plaque psoriasis - ND

Conditions: Moderate to severe chronic plaque psoriasis
MedDRA version: 9.1Level: LLTClassification code 10037153

Registration Number: EUCTR2010-019283-36-IT

Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 320

Inclusion Criteria

A) Induction period (Day 1 to Week 16):1. Males and females aged 18 to 60 years (inclusive) 2. Moderate to severe plaque psoriasis with BSA involvement > 10%, and PASI score > 10 at screening and randomization and requiring systemicTreatment 3. Women of childbearing potential must have a negative serum pregnancy test at screeningand a negative urine pregnancy test at randomization(before the first study drug intake) and agree to use two methods of contraception from the screening visit until 2 months after study drug discontinuation.B) Maintenance period (Week 16 to Week 28):1. Patients achieving at least 50% improvement from baseline in PASI (PASI50) at Week 16.
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Generalized erythrodermic, generalized pustular, guttate, and palmo-plantar psoriasis 2. Topical or systemic treatments for psoriasis other than emollients (within the timelines described by the protocol) 3. Patients receiving immunosuppressive or immunomodulatory treatment for autoimmune disorders other than psoriasis. 4. Ongoing bacterial, viral or fungal infection, positive hepatitis B test or hepatitis C antibody tests. 5. Congenital or acquired severe immunodeficiency or known HIV infection 6. A negative antibody test for varicella-zoster virus atscreening 7. History or presence of malignancy, lymphoproliferative disease total body lymphoid irradiation or bone marrow transplantation 8. History or presence of macular edema or diabetic retinopathy 9. Cardiovascular disease or ECG abnormalities as described in the protocol 10. Lung disease of Pulmonary Function Test abnormalities as described in the protocol 11. Patients with diabetes mellitus Type 1 and 2 12. Active or latent tuberculosis 13. laboratory values abnormalities at screening, as described in the protocol