Phase
Condition
Warts
Scalp Disorders
Psoriasis And Psoriatic Disorders
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient with moderate-to-severe chronic plaque psoriasis who has involved body surfacearea (BSA) ≥ 10% (Palm Method), ≥ 12 on the PASI, and static Physicians GlobalAssessments (sPGA) ≥ 3 (moderate) at Screening and at BL.
Patient has had stable psoriatic disease for at least 2 months (ie, withoutsignificant changes as defined by the Investigator or designee).
Patient is a candidate for systemic therapy and the patient has a previous failure,inadequate response, intolerance, or contraindication to at least 1 systemicantipsoriatic therapy including, but not limited to, methotrexate, cyclosporine,psoralen plus ultraviolet light A (PUVA), and ultraviolet light B (UVB).
Exclusion
Exclusion Criteria:
Patient has prior use of 2 or more biologics for treatment of PsO.
Patient diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,medication-induced psoriasis, other skin conditions (eg, eczema), or other systemicautoimmune disorder inflammatory disease at the time of the Screening visit that wouldinterfere with evaluations of the effect of the study drug on psoriasis.
Patient has prior use of any of the following medications within specified timeperiods or will require use during the study:
Topical medications within 2 weeks of BL (Week 1).
PUVA phototherapy and/or UVB phototherapy within 4 weeks prior to the BL Visit.
Nonbiologic psoriasis systemic therapies (eg, cyclosporine, methotrexate, andacitretin) within 4 weeks prior to the BL Visit.
Any prior or concomitant or biosimilar adalimumab therapy, either approved orinvestigational.
Any systemic steroid in the 4 weeks prior to BL. Note: Only key inclusion/exclusion criteria mentioned here. Patients will be screened andrandomized per the list in the protocol
Study Design
Study Description
Connect with a study center
Innomedica OU
Tallin, 10117
EstoniaSite Not Available
OU Vahlberg & Pild
Tallin, 10134
EstoniaSite Not Available
North Estonia Medical Centre Foundation, Dermatovenerology Centre
Tallinn, 13419
EstoniaSite Not Available
Tartu University Hospital, Dermatology Clinic
Tartu, 50406
EstoniaSite Not Available
Aleksandre Aladashvili Clinic LLC
Tbilisi, 0102
GeorgiaSite Not Available
David Abuladze Georgian-Italian Clinic LTD
Tbilisi, 0179
GeorgiaSite Not Available
Health Institute LLC
Tbilisi, 0160
GeorgiaSite Not Available
Scientific Research National Center of Dermatology and Venereology LLC
Tbilisi, 0159
GeorgiaSite Not Available
The first University Clinic of Tbilisi State Medical University
Tbilisi, 0141
GeorgiaSite Not Available
ClinicMed Daniluk, Nowak Spółka Jawna
Białystok,
PolandSite Not Available
NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik
Białystok,
PolandSite Not Available
Centrum Badań Klinicznych PI-House Sp. Z o.o.
Gdańsk, 80-546
PolandSite Not Available
Synexus Polska Sp. z o.o. Oddział w Gdańsku
Gdańsk,
PolandSite Not Available
Center Med Kraków Sp. Z o.o.
Kraków,
PolandSite Not Available
NZOZ "Nasz Lekarz" Sławomir Jeka, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną
Toruń,
PolandSite Not Available
Synexus Polska Sp. z o.o.Oddział w Warszawie
Warsaw,
PolandSite Not Available
DermMedica Sp. z o.o.
Wrocław,
PolandSite Not Available
Synexus Polska Sp. z o.o. Oddział we Wrocławiu
Wrocław,
PolandSite Not Available
Centrum Medyczna ALL-MED
Łódź,
PolandSite Not Available
Dnepropetrovsk Region Clinical Dermatology and Venerology Dispensary
Dnepropetrovsk,
UkraineSite Not Available
Medical Center "Dzerkalo"
Dnipro,
UkraineSite Not Available
Ivano-Frankivsk Regional Clinical Dermatology and Venereology Dispensary
Ivano-Frankivs'k, 76018
UkraineSite Not Available
Institute of Dermatology and Venerology of NAMS of Ukraine
Kharkiv,
UkraineSite Not Available
Oleksandrivska Clinical Hospital of Kyiv City
Kyiv,
UkraineSite Not Available
Lviv Medical Clinical Center Hospital of Ukrainian State Border Guard Services, Deptment of Dermatovenereology
Lviv,
UkraineSite Not Available
Rivne Regional Dermatology and Venereology Dispensary
Rivne,
UkraineSite Not Available
Diagnostic and Treatment Center ASKLEPII
Uzhhorod,
UkraineSite Not Available
Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary
Zaporizhzhya,
UkraineSite Not Available
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