NCT05842213

Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX

Randomized, Double-blind, 2-arm Multicenter Study to Investigate the Efficacy, Safety and Immunogenicity Between Subcutaneous AVT05 and EU-approved Simponi® in Subjects with Moderate to Severe Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 502 (actual)
• Sponsor: Alvotech Swiss AG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a study to compare the efficacy, safety and immunogenicity of AVT05 versus EU-Simponi® in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA). The study will consist of up to 4-week Screening Period, a 48-week Treatment Period, and a 4-week Safety Follow-up Period.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	AVT05 (proposed biosimilar to golimumab)	AVT05 is a recombinant human IgG1қ mAb developed as a subcutaneous injection
BIOLOGICAL	Simponi (Golimumab)	Simponi (Golimumab) is a recombinant human IgG1қ mAb developed as a subcutaneous injection

Timeline

• Start date: 2023-03-30
• Primary completion: 2024-03-04
• Completion: 2024-09-24
• First posted: 2023-05-03
• Last updated: 2024-10-02

Locations

1 site across 1 country: Bulgaria