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

NCT ID: NCT03849404

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 413 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-20
• Study Completion Date: 2020-07-20

Brief Summary

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

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.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Adalimumab

Intervention Type: BIOLOGICAL

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

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

Group Type: EXPERIMENTAL

Adalimumab

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alvotech Swiss AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Feldman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Innomedica OU

Tallinn, , Estonia

OU Vahlberg & Pild

Tallinn, , Estonia

North Estonia Medical Centre Foundation, Dermatovenerology Centre

Tallinn, , Estonia

Tartu University Hospital, Dermatology Clinic

Tartu, , Estonia

Aleksandre Aladashvili Clinic LLC

Tbilisi, , Georgia

The first University Clinic of Tbilisi State Medical University

Tbilisi, , Georgia

Scientific Research National Center of Dermatology and Venereology LLC

Tbilisi, , Georgia

Health Institute LLC

Tbilisi, , Georgia

David Abuladze Georgian-Italian Clinic LTD

Tbilisi, , Georgia

ClinicMed Daniluk, Nowak Spółka Jawna

Bialystok, , Poland

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

Bialystok, , Poland

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

Gdansk, , Poland

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

Gdansk, , Poland

Center Med Kraków Sp. Z o.o.

Krakow, , Poland

Centrum Medyczna ALL-MED

Lodz, , Poland

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

Torun, , Poland

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

Warsaw, , Poland

DermMedica Sp. z o.o.

Wroclaw, , Poland

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

Wroclaw, , Poland

Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary

Zaporizhzhya, , Ukraine

Countries

Estonia; Georgia; Poland; Ukraine

References

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.

Reference Type: DERIVED

PMID: 34657274 (View on PubMed)

Other Identifiers

AVT02-GL-301

Identifier Type: -

Identifier Source: org_study_id