Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT03849404
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2019-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy, Safety, and Immunogenicity of AVT02 With Moderate-to-Severe Chronic Plaque Psoriasis
Sponsor:
Alvotech Swiss AG
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: