ain457 regimen finding study in patients with moderate to severe psoriasis

Conditions: Chronic Plaque-type Psoriasis

Summary: the purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, ain457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).


Eligibility criteria:
inclusion criteria: * 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 exclusion criteria: * 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 * pregnant or nursing (lactating) women

Keywords: moderate to severe chronic plaque-type psoriasis ain457 dermatology