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

Phase 3

Completed

• Conditions: Plaque Psoriasis
• Interventions: Biological: Adalimumab

• Registration Number: NCT03849404
• Lead Sponsor: Alvotech Swiss AG

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.

Study Timeline

• Study First Submitted: 2019-02-05
• Study Start: 2019-02-20
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-21
• Status Verified: 2019-12
• Primary Completion: 2019-12-23
• Study Completion: 2020-07-20
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 413

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Psoriasis Area and Severity Index (PASI)	Baseline to Week 16	Percent (%) change in Psoriasis Area and Severity Index (PASI)

Secondary Outcome Measures

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

Trial Locations

Locations (20)

DermMedica Sp. z o.o.; 🇵🇱 Wrocław, Poland

OU Vahlberg & Pild; 🇪🇪 Tallin, Estonia

Tartu University Hospital, Dermatology Clinic; 🇪🇪 Tartu, Estonia

North Estonia Medical Centre Foundation, Dermatovenerology Centre; 🇪🇪 Tallinn, Estonia

Innomedica OU; 🇪🇪 Tallin, Estonia

The first University Clinic of Tbilisi State Medical University; 🇬🇪 Tbilisi, Georgia

Health Institute LLC; 🇬🇪 Tbilisi, Georgia

NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik; 🇵🇱 Białystok, Poland

Synexus Polska Sp. z o.o. Oddział w Gdańsku; 🇵🇱 Gdańsk, Poland

Scientific Research National Center of Dermatology and Venereology LLC; 🇬🇪 Tbilisi, Georgia

ClinicMed Daniluk, Nowak Spółka Jawna; 🇵🇱 Białystok, Poland

Centrum Badań Klinicznych PI-House Sp. Z o.o.; 🇵🇱 Gdańsk, Poland

Centrum Medyczna ALL-MED; 🇵🇱 Łódź, Poland

Synexus Polska Sp. z o.o. Oddział we Wrocławiu; 🇵🇱 Wrocław, Poland

Aleksandre Aladashvili Clinic LLC; 🇬🇪 Tbilisi, Georgia

David Abuladze Georgian-Italian Clinic LTD; 🇬🇪 Tbilisi, Georgia

NZOZ "Nasz Lekarz" Sławomir Jeka, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną; 🇵🇱 Toruń, Poland

Synexus Polska Sp. z o.o.Oddział w Warszawie; 🇵🇱 Warsaw, Poland

Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary; 🇺🇦 Zaporizhzhya, Ukraine

Center Med Kraków Sp. Z o.o.; 🇵🇱 Kraków, Poland