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

Plaque Psoriasis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03849404
• Other study ID #: AVT02-GL-301
• Status: Completed
• Phase: Phase 3
• Start date: February 20, 2019
• Est. completion date: July 20, 2020

Study information

• Verified date: December 2019
• Source: Alvotech Swiss AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: July 20, 2020
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

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

Locations

Country	Name	City	State
Estonia	Innomedica OU	Tallin
Estonia	OU Vahlberg & Pild	Tallin
Estonia	North Estonia Medical Centre Foundation, Dermatovenerology Centre	Tallinn
Estonia	Tartu University Hospital, Dermatology Clinic	Tartu
Georgia	Aleksandre Aladashvili Clinic LLC	Tbilisi
Georgia	David Abuladze Georgian-Italian Clinic LTD	Tbilisi
Georgia	Health Institute LLC	Tbilisi
Georgia	Scientific Research National Center of Dermatology and Venereology LLC	Tbilisi
Georgia	The first University Clinic of Tbilisi State Medical University	Tbilisi
Poland	ClinicMed Daniluk, Nowak Spólka Jawna	Bialystok
Poland	NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik	Bialystok
Poland	Centrum Badan Klinicznych PI-House Sp. Z o.o.	Gdansk
Poland	Synexus Polska Sp. z o.o. Oddzial w Gdansku	Gdansk
Poland	Center Med Kraków Sp. Z o.o.	Kraków
Poland	Centrum Medyczna ALL-MED	Lódz
Poland	NZOZ "Nasz Lekarz" Slawomir Jeka, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna	Torun
Poland	Synexus Polska Sp. z o.o.Oddzial w Warszawie	Warsaw
Poland	DermMedica Sp. z o.o.	Wroclaw
Poland	Synexus Polska Sp. z o.o. Oddzial we Wroclawiu	Wroclaw
Ukraine	Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary	Zaporizhzhya

Sponsors (1)

Lead Sponsor	Collaborator
Alvotech Swiss AG

Countries where clinical trial is conducted

Estonia,  Georgia,  Poland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psoriasis Area and Severity Index (PASI)	Percent (%) change in Psoriasis Area and Severity Index (PASI)	Baseline to Week 16
Secondary	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