Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Men or women at least 18 years of age at time of consent
Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
At time of randomization, moderate to severe psoriasis as defined by:
* PASI score of 12 or greater and
* IGA score of 3 or greater and
* Body Surface Area (BSA) affected by plaque-type psoriasis of 10 % or greater
At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by:
* topical treatment and/or
* phototherapy and/or
* previous systemic therapy
You may not be if
Patients meeting any of the following criteria will be excluded from entry into the study:
Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or randomization
Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) and randomization
Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy) at randomization. Washout periods detailed in the study protocol have to be adhered to
Ongoing use of other prohibited treatments at randomization. Washout periods detailed in the study protocol have to be adhered to. All prior concomitant medications must be on a stable dose for at least four weeks before study drug administration
Known immunosuppression (e.g., AIDS) at screening and / or randomization
History or evidence of active tuberculosis at screening. All patients will be tested for tuberculosis status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations.
Active systemic infections (other than common cold) during the two weeks before randomization (e.g., hepatitis)
At screening, history or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratoses, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
History of congestive heart failure (NYHA functional classification ≥III) at screening and / or randomization
History of severe hypersensitivity to any human or humanized biological agents (antibody or soluble receptor) at screening and / or randomization
Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study
