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.

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

202

Study ID:

NCT05190419

Recruitment Status:

Completed

Sponsor:

UNION therapeutics

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There are 7 Locations for this study

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Central Connecticut Dermatology
Cromwell Connecticut, 06416, United States
GWU MFA
Washington District of Columbia, 20037, United States
ALLCUTIS Research, LLC
Beverly Massachusetts, 01915, United States
ALLCUTIS Research, LLC
Portsmouth New Hampshire, 03801, United States
Bruce E. Katz, MD
New York New York, 10022, United States
Sadick Research Group LLC
New York New York, 10075, United States
Apex Clinical Research Center
Mayfield Heights Ohio, 44124, 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
Muenchen , , Germany
KliFOs - Klinische Forschung Osnabrueck
Osnabrück , , Germany
NZOZ Specjalistyczny Orodek Dermatologiczny DERMAL
Białystok , , 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
Kraków , , 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
Wrocław , , Poland
dermMedica Sp z.o.o
Wrocław , , Poland
Wromedica
Wrocław , , Poland
Medicines Evaluation Unit
Manchester , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

202

Study ID:

NCT05190419

Recruitment Status:

Completed

Sponsor:


UNION therapeutics

How clear is this clinincal trial information?

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