NCT06596772

A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis

A Prospective, Randomized, Double-blind, Parallel-group Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of MB04 and EU-sourced Enbrel® in Patients with Moderate to Severe Rheumatoid Arthritis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 458 (estimated)
• Sponsor: mAbxience Research S.L. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 \[proposed etanercept biosimilar\] to Enbrel® \[EU-sourced\] in rheumatoid arthritis

Detailed description

The study will randomize approximately 458 patients aged between 18 and 75 years with active Rheumatoid Arthritis despite methotrexate therapy. All patients shall receive methotrexate for ≥12 weeks and on a stable dose (10 to 25 mg/week) for ≥8 weeks prior to randomization, and folic acid (≥5 mg/week) from 4 weeks prior to screening until the end of the treatment period (Week 36). Screening evaluations will be completed within 28 days prior to randomization. There will be 2 periods in the study: Main Treatment period and Transition period. During the Main Treatment Period, eligible patients will be randomized, at a 1:1 ratio, to administer a 50 mg weekly dose of MB04 or EU- sourced Enbrel® subcutaneously (SC) using an Interactive Response System (IRT). After completing Week 24 assessment, patients will continue to receive the study treatment up to Week 36. Those patients who were originally assigned to EU-sourced Enbrel® will be randomized, at a 1:1 ratio, to receive either MB04 or EU-sourced Enbrel® SC, while patients originally assigned to MB04 will continue with the same treatment until Week 36. After treatment discontinuation, patients will undergo a Safety follow-up period for 4 weeks, up to week 40.

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
DRUG	MB04 (proposed biosimilar to etanercept)	MB04 50 mg/week via subcutaneous injection
DRUG	Enbrel (etanercept)	Enbrel 50 mg/week via subcutaneous injection

Timeline

• Start date: 2024-10-03
• Primary completion: 2025-10-01
• Completion: 2026-01-01
• First posted: 2024-09-19
• Last updated: 2025-03-24

Locations

60 sites across 6 countries: Bulgaria, Georgia, Moldova, Poland, Romania, Serbia