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

NCT03849404 | Completed Phase 3

• 1 other identifier: AVT02-GL-301
• Study Type: interventional
• Target: 413
• Locations: 4 countries
• Sites: 20

Brief Summary

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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Psoriasis Area and Severity Index (PASI)

  Percent (%) change in Psoriasis Area and Severity Index (PASI)

  Baseline to Week 16

Secondary Outcomes (1)

• Psoriasis Area and Severity Index (PASI)

  Percent improvement in PASI from BL to Week 8, 12, 24, 32, 42, and 50

Study Arms (2)

AVT02 100mg/mL (Adalimumab Biosimilar)

EXPERIMENTAL

Patients will be randomized to AVT02 on 1: 1 basis from the dosing day of Day 1 until week 48

Biological: Adalimumab

EU-Humira 100mg/mL (Adalimumab Originator)

EXPERIMENTAL

Patients will be randomized to EU-Humira on 1: 1 basis from the dosing day of Day 1 until week 48

Biological: Adalimumab

Interventions

Adalimumab 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

AVT02 100mg/mL (Adalimumab Biosimilar); EU-Humira 100mg/mL (Adalimumab Originator)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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:
• 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, and acitretin) within 4 weeks prior to the BL Visit.
• Any prior or concomitant or biosimilar adalimumab therapy, either approved or investigational.
• Any systemic steroid in the 4 weeks prior to BL.

Sponsors & Collaborators

• Alvotech Swiss AG: lead

Study Sites (20)

Innomedica OU

Tallinn, 10117, Estonia

Location

OU Vahlberg & Pild

Tallinn, 10134, Estonia

Location

North Estonia Medical Centre Foundation, Dermatovenerology Centre

Tallinn, 13419, Estonia

Location

Tartu University Hospital, Dermatology Clinic

Tartu, 50406, Estonia

Location

Aleksandre Aladashvili Clinic LLC

Tbilisi, 0102, Georgia

Location

The first University Clinic of Tbilisi State Medical University

Tbilisi, 0141, Georgia

Location

Scientific Research National Center of Dermatology and Venereology LLC

Tbilisi, 0159, Georgia

Location

Health Institute LLC

Tbilisi, 0160, Georgia

Location

David Abuladze Georgian-Italian Clinic LTD

Tbilisi, 0179, Georgia

Location

ClinicMed Daniluk, Nowak Spółka Jawna

Bialystok, Poland

Location

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

Bialystok, Poland

Location

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

Gdansk, 80-546, Poland

Location

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

Gdansk, Poland

Location

Center Med Kraków Sp. Z o.o.

Krakow, Poland

Location

Centrum Medyczna ALL-MED

Lodz, Poland

Location

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

Torun, Poland

Location

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

Warsaw, Poland

Location

DermMedica Sp. z o.o.

Wroclaw, Poland

Location

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

Wroclaw, Poland

Location

Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary

Zaporizhzhya, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 34657274 DERIVED

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Steven Feldman, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 21, 2019
• Study Start: February 20, 2019
• Primary Completion: December 23, 2019
• Study Completion: July 20, 2020
• Last Updated: July 28, 2020

Record last verified: 2019-12

Locations

GE (5); ES (4); UA (1); PL (10)