Study to Assess the Efficacy and Safety of Orismilast in Psoriasis
NCT ID: NCT05190419
Last Updated: 2024-04-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
202 participants
INTERVENTIONAL
2021-12-30
2022-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Orismilast modified release tablets 20 mg BID
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets
Orismilast modified release is a next generation phosphodiesterase-4 (PDE4) inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
Orismilast modified release tablets 30 mg BID
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets
Orismilast modified release is a next generation phosphodiesterase-4 (PDE4) inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
Orismilast modified release tablets 40 mg BID
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets
Orismilast modified release is a next generation phosphodiesterase-4 (PDE4) inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
Placebo tablets BID
Oral, twice daily morning and evening for 16 weeks
Placebo
Matching placebo tablets
Interventions
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Orismilast modified release tablets
Orismilast modified release is a next generation phosphodiesterase-4 (PDE4) inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
Placebo
Matching placebo tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male and female patients ≥18 years of age
3. Body weight of \>40 kg
4. Diagnosis of chronic, stable plaque-type psoriasis. If the patient is diagnosed with psoriasis arthritis, the arthritis should be stable.
5. 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.
6. Candidate for systemic antipsoriatic treatment or phototherapy.
Exclusion Criteria
2. Unstable psoriasis or psoriatic arthritis with acute deterioration within 4 weeks of the Screening visit.
3. History of allergy or hypersensitivity to any component of the study treatment.
4. Active infection (eg, bacteria, viral, fungal) requiring treatment with systemic antibiotics within 4 weeks of the Screening visit.
5. Malignancy or history of malignancy except for treated (ie, cured) basal cell skin carcinomas.
18 Years
ALL
No
Sponsors
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UNION therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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P. A., MD
Role: STUDY_DIRECTOR
UNION therapeutics A/S
Locations
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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
Laser Clinic
Szczecin, , Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, , Poland
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o.
Tarnów, , Poland
High-Med.Przychodnia Specjalistyczna
Warsaw, , Poland
Klinika Ambroziak
Warsaw, , Poland
CityClinic Przychodnia Lekarsko-Psychologiczna
Wroclaw, , Poland
dermMedica Sp z.o.o
Wroclaw, , Poland
Wromedica
Wroclaw, , Poland
Medicines Evaluation Unit
Manchester, , United Kingdom
Countries
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References
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Warren RB, Weiss A, Felding J, Sommer MOA, Garcet S, Krueger JG. Orismilast, a Potent and Selective PDE4B/D Inhibitor, Reduces Protein Levels of Key Disease Driving Cytokines in the Skin of Patients With Plaque Psoriasis. Exp Dermatol. 2025 Sep;34(9):e70153. doi: 10.1111/exd.70153.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-003209-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
UNI50001-203
Identifier Type: -
Identifier Source: org_study_id
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