Status:
COMPLETED
Study to Assess the Efficacy and Safety of Orismilast in Psoriasis
Lead Sponsor:
UNION therapeutics
Conditions:
Psoriasis
Skin Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2022
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT05190419
Start Date
December 30 2021
End Date
December 20 2022
Last Update
April 16 2024
Active Locations (34)
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1
Central Connecticut Dermatology
Cromwell, Connecticut, United States, 06416
2
GWU MFA
Washington D.C., District of Columbia, United States, 20037
3
ALLCUTIS Research, LLC
Beverly, Massachusetts, United States, 01915
4
ALLCUTIS Research, LLC
Portsmouth, New Hampshire, United States, 03801