NCT03849404

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 413 (actual)
• Sponsor: Alvotech Swiss AG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-02-20
• Primary completion: 2019-12-23
• Completion: 2020-07-20
• First posted: 2019-02-21
• Last updated: 2020-07-28

Locations

20 sites across 4 countries: Estonia, Georgia, Poland, Ukraine