Psoriasis Clinical Trial
Study to Assess the Efficacy and Safety of Orismilast in Psoriasis
Summary
This study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe plaque-type psoriasis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe plaque-type psoriasis and assess the safety aspects of these 3 different doses.The patients will receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks.
Eligibility Criteria
Inclusion Criteria:
Capable of giving signed informed consent.
Male and female patients ≥18 years of age
Body weight of >40 kg
Diagnosis of chronic, stable plaque-type psoriasis. If the patient is diagnosed with psoriasis arthritis, the arthritis should be stable.
Moderate-to-severe plaque-type psoriasis as defined by Psoriasis Activity and Severity Index (PASI) ≥12, body surface area (BSA) ≥10%, and Investigator Global Assessment (IGA) ≥3.
Candidate for systemic antipsoriatic treatment or phototherapy.
Exclusion Criteria:
Therapy-resistant psoriasis
Unstable psoriasis or psoriatic arthritis with acute deterioration within 4 weeks of the Screening visit.
History of allergy or hypersensitivity to any component of the study treatment.
Active infection (eg, bacteria, viral, fungal) requiring treatment with systemic antibiotics within 4 weeks of the Screening visit.
Malignancy or history of malignancy except for treated (ie, cured) basal cell skin carcinomas.
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There are 7 Locations for this study
Cromwell Connecticut, 06416, United States
Washington District of Columbia, 20037, United States
Beverly Massachusetts, 01915, United States
Portsmouth New Hampshire, 03801, United States
New York New York, 10022, United States
New York New York, 10075, United States
Mayfield Heights Ohio, 44124, United States
Bad Bentheim , , Germany
Berlin , , Germany
Darmstadt , , Germany
Dresden , , Germany
Friedrichshafen , , Germany
Hamburg , , Germany
Hamburg , , Germany
Kiel , , Germany
Langenau , , Germany
Mahlow , , Germany
Muenchen , , Germany
Osnabrück , , Germany
Białystok , , Poland
Chorzów , , Poland
Iwonicz-Zdrój , , Poland
Katowice , , Poland
Kraków , , Poland
Malbork , , Poland
Szczecin , , Poland
Szczecin , , Poland
Tarnów , , Poland
Warsaw , , Poland
Warsaw , , Poland
Wrocław , , Poland
Wrocław , , Poland
Wrocław , , Poland
Manchester , , United Kingdom
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