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

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)

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

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Biological: Adalimumab

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 413
• Phase: Phase 3

Contacts and Locations

Study Locations

• Estonia
  • Tallin, Estonia, 10117
    • Innomedica OÜ
  • Tallin, Estonia, 10134
    • OU Vahlberg & Pild
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation, Dermatovenerology Centre
  • Tartu, Estonia, 50406
    • Tartu University Hospital, Dermatology Clinic
• Georgia
  • Tbilisi, Georgia, 0160
    • Health Institute LLC
  • Tbilisi, Georgia, 0102
    • Aleksandre Aladashvili Clinic LLC
  • Tbilisi, Georgia, 0141
    • The First University Clinic of Tbilisi State Medical University
  • Tbilisi, Georgia, 0159
    • Scientific Research National Center of Dermatology and Venereology LLC
  • Tbilisi, Georgia, 0179
    • David Abuladze Georgian-Italian Clinic LTD
• Poland
  • Białystok, Poland
    • ClinicMed Daniluk, Nowak Spółka Jawna
  • Białystok, Poland
    • NZOZ OSTEO-MEDIC S.C. Artur Racewicz, Jerzy Supronik
  • Gdańsk, Poland, 80-546
    • Centrum Badan Klinicznych PI-House sp. z o.o.
  • Gdańsk, Poland
    • Synexus Polska Sp. z o.o. Oddział w Gdańsku
  • Kraków, Poland
    • Center Med Kraków Sp. Z o.o.
  • Toruń, Poland
    • NZOZ "Nasz Lekarz" Sławomir Jeka, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną
  • Warsaw, Poland
    • Synexus Polska Sp. z o.o.Oddział w Warszawie
  • Wrocław, Poland
    • Dermmedica Sp. Z O.O.
  • Wrocław, Poland
    • Synexus Polska Sp. z o.o. Oddział we Wrocławiu
  • Łódź, Poland
    • Centrum Medyczna ALL-MED
• Ukraine
  • Zaporizhzhya, Ukraine
    • Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient with moderate-to-severe chronic plaque psoriasis who has involved body surface area (BSA) ≥ 10% (Palm Method), ≥ 12 on the PASI, and static Physicians Global Assessments (sPGA) ≥ 3 (moderate) at Screening and at BL.
• Patient has had stable psoriatic disease for at least 2 months (ie, without significant 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 systemic antipsoriatic therapy including, but not limited to, methotrexate, cyclosporine, psoralen plus ultraviolet light A (PUVA), and ultraviolet light B (UVB).

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 systemic autoimmune disorder inflammatory disease at the time of the Screening visit that would interfere with evaluations of the effect of the study drug on psoriasis.

• Patient has prior use of any of the following medications within specified time periods 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, and acitretin) within 4 weeks prior to the BL Visit.
  4. Any prior or concomitant or biosimilar adalimumab therapy, either approved or investigational.
  5. Any systemic steroid in the 4 weeks prior to BL.

Note: Only key inclusion/exclusion criteria mentioned here. Patients will be screened and randomized per the list in the protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AVT02 100mg/mL (Adalimumab Biosimilar); Patients will be randomized to AVT02 on 1: 1 basis from the dosing day of Day 1 until week 48	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
Experimental: EU-Humira 100mg/mL (Adalimumab Originator); Patients will be randomized to EU-Humira on 1: 1 basis from the dosing day of Day 1 until week 48	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis Area and Severity Index (PASI)	Percent (%) change in Psoriasis Area and Severity Index (PASI)	Baseline to Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis Area and Severity Index (PASI)	Percent (%) change in Psoriasis Area and Severity Index (PASI)	Percent improvement in PASI from BL to Week 8, 12, 24, 32, 42, and 50

Collaborators and Investigators

• Sponsor: Alvotech Swiss AG
• Investigators: Principal Investigator: Steven Feldman, MD, PhD, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• Feldman SR, Reznichenko N, Pulka G, Kingo K, George Galdava, Berti F, Sobierska J, Dias R, Guenzi E, Hendrik Otto, Haliduola HN, Kay R, Stroissnig H. Efficacy, Safety and Immunogenicity of AVT02 Versus Originator Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis: A Multicentre, Double-Blind, Randomised, Parallel Group, Active Control, Phase III Study. BioDrugs. 2021 Nov;35(6):735-748. doi: 10.1007/s40259-021-00502-w. Epub 2021 Oct 16.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2019
• Primary Completion (Actual): December 23, 2019
• Study Completion (Actual): July 20, 2020

Study Registration Dates

• First Submitted: February 5, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: AVT02-GL-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No