Clinical trial NCT03849404: Efficacy, Safety, and Immunogenicity of AVT02 With Moderate-to-Severe Chronic Plaque Psoriasis
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Alvotech Swiss AG
Sponsor class: INDUSTRY
First posted: 2019-02-21
Enrollment: 413
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Psoriasis Area and Severity Index (PASI)
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Psoriasis Area and Severity Index (PASI)
timeFrame: Percent improvement in PASI from BL to Week 8, 12, 24, 32, 42, and 50
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation, Dermatovenerology Centre
city: Tallin
country: Estonia
facility: Innomedica OU
city: Tallin
country: Estonia
facility: OU Vahlberg & Pild
city: Tartu
country: Estonia
facility: Tartu University Hospital, Dermatology Clinic
city: Tbilisi
country: Georgia
facility: Aleksandre Aladashvili Clinic LLC
city: Tbilisi
country: Georgia
facility: The first University Clinic of Tbilisi State Medical University
city: Tbilisi
country: Georgia
facility: Scientific Research National Center of Dermatology and Venereology LLC
city: Tbilisi
country: Georgia
facility: Health Institute LLC
city: Tbilisi
country: Georgia
facility: David Abuladze Georgian-Italian Clinic LTD
city: Białystok
country: Poland
facility: ClinicMed Daniluk, Nowak Spółka Jawna
city: Białystok
country: Poland
facility: NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik
city: Gdańsk
country: Poland
facility: Centrum Badań Klinicznych PI-House Sp. Z o.o.
city: Gdańsk
country: Poland
facility: Synexus Polska Sp. z o.o. Oddział w Gdańsku
city: Kraków
country: Poland
facility: Center Med Kraków Sp. Z o.o.
city: Toruń
country: Poland
facility: NZOZ "Nasz Lekarz" Sławomir Jeka, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną
city: Warsaw
country: Poland
facility: Synexus Polska Sp. z o.o.Oddział w Warszawie
city: Wrocław
country: Poland
facility: DermMedica Sp. z o.o.
city: Wrocław
country: Poland
facility: Synexus Polska Sp. z o.o. Oddział we Wrocławiu
city: Łódź
country: Poland
facility: Centrum Medyczna ALL-MED
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steven Feldman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.