Study to Assess the Efficacy and Safety of Orismilast in Psoriasis
Completed · Phase 2 · Has a placebo group
Conditions studied: Psoriasis, Skin Diseases
In brief
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.
Key facts
- Study ID
- NCT05190419
- Run by
- UNION therapeutics
- People needed
- 202
- Starts
- 2021-12-30
- Expected to finish
- 2022-12-20
- Last updated by the study team
- 2024-04-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Central Connecticut Dermatology — Cromwell, Connecticut, United States
- GWU MFA — Washington D.C., District of Columbia, United States
- ALLCUTIS Research, LLC — Beverly, Massachusetts, United States
- ALLCUTIS Research, LLC — Portsmouth, New Hampshire, United States
- Bruce E. Katz, MD — New York, New York, United States
- Sadick Research Group LLC — New York, New York, United States
- Apex Clinical Research Center — Mayfield Heights, Ohio, United States
- Fachklinik Bad Bentheim — Bad Bentheim, Germany
- ISA - Interdisciplinary Study Association GmbH — Berlin, Germany
- Rosenpark Research GmbH — Darmstadt, Germany
- Hautarztpraxis Dr.Gerlach — Dresden, Germany
- Derma-Study-Center-Friedrichshafen — Friedrichshafen, Germany
- Klinische Forschung Hamburg GmbH — Hamburg, Germany
- TFS Trial From Support GmbH — Hamburg, Germany
- MVZ DermaKiel GmbH — Kiel, Germany
- Studienzentrum Dr.Beate Schwarz — Langenau, Germany
- Hautarztpraxis Mahlow — Mahlow, Germany
- LMU Muenchen, Klinik und Poliklinik fur Dermatologie und Allergologie — München, Germany
- KliFOs - Klinische Forschung Osnabrueck — Osnabrück, Germany
- NZOZ Specjalistyczny Orodek Dermatologiczny DERMAL — Bialystok, Poland
- Specjalistyczna Praktyka Lekarska Gabinet Dermatologiczny dr n.med. Edyta Gebska — Chorzów, Poland
- Zespol Naukowo - Leczniczy Dermatologiczne Centrum Uzdrowiskowe Iwolang Sp. z o.o. — Iwonicz-Zdrój, Poland
- Provita Sp. z o.o. — Katowice, Poland
- Centrum Medyczne All-Med — Krakow, Poland
- Klinika Badawcza — Malbork, Poland
Full record on ClinicalTrials.gov
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