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

Phase 3

Recruiting

• Conditions: Rheumatoid Arthritis (RA)
• Interventions: Drug: MB04 (proposed biosimilar to etanercept); Drug: Enbrel (etanercept)

• Registration Number: NCT06596772
• Lead Sponsor: mAbxience Research S.L.

Brief 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.

Study Timeline

• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-16
• Study First Posted: 2024-09-19
• Study Start: 2024-10-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24
• Primary Completion: 2025-10
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 458

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MB04 (proposed etanercept biosimilar)	MB04 (proposed biosimilar to etanercept)	MB04 50 mg/week via subcutaneous injection
Enbrel (etanercept)	Enbrel (etanercept)	Enbrel 50 mg/week via subcutaneous injection

Primary Outcome Measures

Name	Time	Method
American College of Rheumatology 20% Response Criteria (ACR20)	Week 24

Secondary Outcome Measures

Name	Time	Method
ACR20	Weeks 36
American College of Rheumatology 50% Response Criteria (ACR50)	Weeks 24 and 36
American College of Rheumatology 70% Response Criteria (ACR70)	Weeks 24 and 36

Trial Locations

Locations (60)

Research site 2007; 🇧🇬 Haskovo, Bulgaria

Research site 2005; 🇧🇬 Plovdiv, Bulgaria

Research Site 2002; 🇧🇬 Ruse, Bulgaria

Research site 2001; 🇧🇬 Sofia, Bulgaria

Research Site 2003; 🇧🇬 Sofia, Bulgaria

Research Site 2008; 🇧🇬 Sofia, Bulgaria

Research site 2004; 🇧🇬 Vidin, Bulgaria

Research site 2006; 🇧🇬 Vratsa, Bulgaria

Research site 7004; 🇬🇪 Batumi, Georgia

Research site 7010; 🇬🇪 Batumi, Georgia

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