Efficacy, Safety, and Immunogenicity of AVT02 With Moderate-to-Severe Chronic Plaque Psoriasis

PHASE3CompletedINTERVENTIONAL
Enrollment

413

Participants

Timeline

Start Date

February 20, 2019

Primary Completion Date

December 23, 2019

Study Completion Date

July 20, 2020

Conditions
Plaque Psoriasis
Interventions
BIOLOGICAL

Adalimumab

Patients in AVT02 arm will receive an initial loading dose of AVT02 80 mg (2 × 40 mg) administered subcutaneously (SC), followed by 40 mg given SC once every other week (EOW) starting 1 week after the loading dose, and will continue to receive AVT02 until Week 48 Patients in EU-Humira arm will receive an initial loading dose of Humira 80 mg (2 × 40 mg) administered SC, followed by 40 mg given SC EOW starting 1 week after the loading dose and will continue to receive Humira until Week 48

Trial Locations (20)

10117

Innomedica OU, Tallinn

10134

OU Vahlberg & Pild, Tallinn

13419

North Estonia Medical Centre Foundation, Dermatovenerology Centre, Tallinn

50406

Tartu University Hospital, Dermatology Clinic, Tartu

0102

Aleksandre Aladashvili Clinic LLC, Tbilisi

0141

The first University Clinic of Tbilisi State Medical University, Tbilisi

0159

Scientific Research National Center of Dermatology and Venereology LLC, Tbilisi

0160

Health Institute LLC, Tbilisi

0179

David Abuladze Georgian-Italian Clinic LTD, Tbilisi

Unknown

ClinicMed Daniluk, Nowak Spółka Jawna, Bialystok

NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik, Bialystok

Synexus Polska Sp. z o.o. Oddział w Gdańsku, Gdansk

Center Med Kraków Sp. Z o.o., Krakow

Centrum Medyczna ALL-MED, Lodz

"NZOZ Nasz Lekarz Sławomir Jeka, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną", Torun

Synexus Polska Sp. z o.o.Oddział w Warszawie, Warsaw

DermMedica Sp. z o.o., Wroclaw

Synexus Polska Sp. z o.o. Oddział we Wrocławiu, Wroclaw

Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary, Zaporizhzhya

80-546

Centrum Badań Klinicznych PI-House Sp. Z o.o., Gdansk

All Listed Sponsors
lead

Alvotech Swiss AG

INDUSTRY

NCT03849404 - Efficacy, Safety, and Immunogenicity of AVT02 With Moderate-to-Severe Chronic Plaque Psoriasis | Biotech Hunter | Biotech Hunter