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

Last updated: July 27, 2020
Sponsor: Alvotech Swiss AG
Overall Status: Completed

Phase

3

Condition

Warts

Scalp Disorders

Psoriasis And Psoriatic Disorders

Treatment

N/A

Clinical Study ID

NCT03849404
AVT02-GL-301
  • Ages 18-75
  • All Genders

Study Summary

Safety and Efficacy study of AVT02 (Alvotech Biosimilar to Adalimumab), in patients with moderate to severe plaque psoriasis.

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:

  1. Topical medications within 2 weeks of BL (Week 1).

  2. PUVA phototherapy and/or UVB phototherapy within 4 weeks prior to the BL Visit.

  3. Nonbiologic psoriasis systemic therapies (eg, cyclosporine, methotrexate, andacitretin) within 4 weeks prior to the BL Visit.

  4. Any prior or concomitant or biosimilar adalimumab therapy, either approved orinvestigational.

  5. 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

Total Participants: 413
Study Start date:
February 20, 2019
Estimated Completion Date:
July 20, 2020

Study Description

A Multicenter, Double-blind, Randomized, Parallel-group, Active Control Study to Compare the Efficacy, Safety, and Immunogenicity of AVT02 Versus Humira® in Patients with Moderate-to-Severe Chronic Plaque Psoriasis (ALVOPAD PS).

This study will be conducted at about 40 study centers in central and eastern European countries. A contract research organization, will oversee operational aspects of this study on behalf of Alvotech Swiss AG (Alvotech), the Sponsor of the study.

Connect with a study center

  • Innomedica OU

    Tallin, 10117
    Estonia

    Site Not Available

  • OU Vahlberg & Pild

    Tallin, 10134
    Estonia

    Site Not Available

  • North Estonia Medical Centre Foundation, Dermatovenerology Centre

    Tallinn, 13419
    Estonia

    Site Not Available

  • Tartu University Hospital, Dermatology Clinic

    Tartu, 50406
    Estonia

    Site Not Available

  • Aleksandre Aladashvili Clinic LLC

    Tbilisi, 0102
    Georgia

    Site Not Available

  • David Abuladze Georgian-Italian Clinic LTD

    Tbilisi, 0179
    Georgia

    Site Not Available

  • Health Institute LLC

    Tbilisi, 0160
    Georgia

    Site Not Available

  • Scientific Research National Center of Dermatology and Venereology LLC

    Tbilisi, 0159
    Georgia

    Site Not Available

  • The first University Clinic of Tbilisi State Medical University

    Tbilisi, 0141
    Georgia

    Site Not Available

  • ClinicMed Daniluk, Nowak Spółka Jawna

    Białystok,
    Poland

    Site Not Available

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

    Białystok,
    Poland

    Site Not Available

  • Centrum Badań Klinicznych PI-House Sp. Z o.o.

    Gdańsk, 80-546
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddział w Gdańsku

    Gdańsk,
    Poland

    Site Not Available

  • Center Med Kraków Sp. Z o.o.

    Kraków,
    Poland

    Site Not Available

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

    Toruń,
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o.Oddział w Warszawie

    Warsaw,
    Poland

    Site Not Available

  • DermMedica Sp. z o.o.

    Wrocław,
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddział we Wrocławiu

    Wrocław,
    Poland

    Site Not Available

  • Centrum Medyczna ALL-MED

    Łódź,
    Poland

    Site Not Available

  • Dnepropetrovsk Region Clinical Dermatology and Venerology Dispensary

    Dnepropetrovsk,
    Ukraine

    Site Not Available

  • Medical Center "Dzerkalo"

    Dnipro,
    Ukraine

    Site Not Available

  • Ivano-Frankivsk Regional Clinical Dermatology and Venereology Dispensary

    Ivano-Frankivs'k, 76018
    Ukraine

    Site Not Available

  • Institute of Dermatology and Venerology of NAMS of Ukraine

    Kharkiv,
    Ukraine

    Site Not Available

  • Oleksandrivska Clinical Hospital of Kyiv City

    Kyiv,
    Ukraine

    Site Not Available

  • Lviv Medical Clinical Center Hospital of Ukrainian State Border Guard Services, Deptment of Dermatovenereology

    Lviv,
    Ukraine

    Site Not Available

  • Rivne Regional Dermatology and Venereology Dispensary

    Rivne,
    Ukraine

    Site Not Available

  • Diagnostic and Treatment Center ASKLEPII

    Uzhhorod,
    Ukraine

    Site Not Available

  • Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary

    Zaporizhzhya,
    Ukraine

    Site Not Available

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