MedTrace Logo

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

NCT06596772 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 458

Last updated 2025-03-24

No results posted yet for this study

Summary

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

Conditions

  • Rheumatoid Arthritis (RA)

Interventions

DRUG

MB04 (proposed biosimilar to etanercept)

MB04 50 mg/week via subcutaneous injection

DRUG

Enbrel (etanercept)

Enbrel 50 mg/week via subcutaneous injection

Sponsors & Collaborators

  • mAbxience Research S.L.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-03
Primary Completion
2025-10-31
Completion
2026-01-31

Countries

  • Bulgaria
  • Georgia
  • Moldova
  • Poland
  • Romania
  • Serbia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06596772 on ClinicalTrials.gov