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

NCT06596772 | Recruiting Phase 3

• 1 other identifier: MB04-C-01-23
• Study Type: interventional
• Target: 458
• Locations: 6 countries
• Sites: 60

Brief 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)

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• American College of Rheumatology 20% Response Criteria (ACR20)

  Week 24

Secondary Outcomes (3)

• 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

Study Arms (2)

MB04 (proposed etanercept biosimilar)

EXPERIMENTAL

MB04 50 mg/week via subcutaneous injection

Drug: MB04 (proposed biosimilar to etanercept)

Enbrel (etanercept)

ACTIVE COMPARATOR

Enbrel 50 mg/week via subcutaneous injection

Drug: Enbrel (etanercept)

Interventions

MB04 (proposed biosimilar to etanercept) DRUG

MB04 50 mg/week via subcutaneous injection

MB04 (proposed etanercept biosimilar)

Enbrel (etanercept) DRUG

Enbrel 50 mg/week via subcutaneous injection

Enbrel (etanercept)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented history of RA diagnosis consistent with the 2010 ACR/EULAR classification criteria ≥6 months prior to randomization (but not exceeding 15 years prior to screening).
• Moderately to severe RA despite appropriate MTX at baseline therapy defined as having more than or equal to six swollen joints and more than or equal to six tender joints and either erythrocyte sedimentation rate (ESR, Westergren) ≥ 28 mm/h or serum C-reactive protein \> 5.0 mg/dL and positive rheumatoid factor and/or CCP at screening
• Stable dose MTX between 10 to 25 mg weekly during ≥12 weeks, since ≥8 weeks prior to randomization
• Stable dose of NSAID and /or other analgesics for at least 4 weeks prior to randomization, when used
• Stable dose ≤10 mg prednisone daily or equivalent for ≥4 weeks prior to randomization, when used
• Patients who are otherwise medically stable according to investigator\'s discretion
• Previously treated with any biologic or targeted synthetic DMARD
• Previously treated with any monoclonal antibody for other condition than RA
• Hypersensitivity to any component of study drug and/or prefilled syringe components
• Arthritis with onset prior to age 16 years or current diagnosis of inflammatory joint disease other than RA
• Systemic manifestations of RA other that rheumatoid nodules or secondary Sjogren\'s syndrome
• Active infection or potentially relapsing infections that could have a severe outcome. Latent tuberculosis infection detected during screening should start an approved treatment regimen according to standard of care and rescreened
• Solid or hematologic malignancy within the past 5 years
• Pregnant and breastfeeding women
• Any medical condition in the opinion of the investigator that would be a risk for safety, cooperation in the study or interferes with the interpretation of the study results

Sponsors & Collaborators

• mAbxience Research S.L.: lead

Study Sites (60)

Research site 2007

Haskovo, Bulgaria

RECRUITING

Research site 2005

Plovdiv, Bulgaria

RECRUITING

Research Site 2002

Rousse, Bulgaria

RECRUITING

Research site 2001

Sofia, Bulgaria

RECRUITING

Research Site 2003

Sofia, Bulgaria

RECRUITING

Research Site 2008

Sofia, Bulgaria

RECRUITING

Research site 2004

Vidin, Bulgaria

RECRUITING

Research site 2006

Vratsa, Bulgaria

RECRUITING

Research site 7004

Batumi, Georgia

RECRUITING

Research site 7010

Batumi, Georgia

RECRUITING

Research site 7001

Tbilisi, Georgia

RECRUITING

Research site 7002

Tbilisi, Georgia

RECRUITING

Research site 7003

Tbilisi, Georgia

RECRUITING

Research site 7005

Tbilisi, Georgia

RECRUITING

Research site 7006

Tbilisi, Georgia

RECRUITING

Research site 7007

Tbilisi, Georgia

RECRUITING

Research site 7009

Tbilisi, Georgia

RECRUITING

Research Site 1301

Chisinau, MD-2068, Moldova

RECRUITING

Research site 1302

Chisinau, MD2025, Moldova

RECRUITING

Research Site 1603

Bialystok, Poland

RECRUITING

Research Site 1614

Bialystok, Poland

RECRUITING

Research site 1616

Bialystok, Poland

RECRUITING

Research site 1613

Bydgoszcz, Poland

RECRUITING

Research site 1623

Bytom, Poland

RECRUITING

Research Site 1615

Elblag, Poland

RECRUITING

Research Site 1627

Elblag, Poland

RECRUITING

Research Site 1606

Gdynia, Poland

RECRUITING

Research Site 1611

Katowice, Poland

RECRUITING

Research Site 1617

Krakow, Poland

RECRUITING

Research Site 1622

Lublin, Poland

RECRUITING

Research site 1605

Nowa Sól, Poland

RECRUITING

Research Site 1618

Opole, Poland

RECRUITING

Research site 1628

Piotrkow Trybunalski, Poland

RECRUITING

Research Site 1624

Poniatowa, Poland

RECRUITING

Resarch Site 1619

Poznan, Poland

RECRUITING

Research Site 1601

Poznan, Poland

RECRUITING

Research Site 1602

Poznan, Poland

RECRUITING

Research Site 1608

Poznan, Poland

RECRUITING

Research Site 1621

Poznan, Poland

RECRUITING

Research Site 1612

Siedlce, Poland

RECRUITING

Research Site 1610

Sochaczew, Poland

RECRUITING

Research site 1629

Stalowa Wola, Poland

RECRUITING

Research Site 1620

Torun, Poland

RECRUITING

Research Site 1604

Warsaw, Poland

RECRUITING

Research Site 1607

Warsaw, Poland

RECRUITING

Research Site 1609

Warsaw, Poland

RECRUITING

Research Site 1625

Wroclaw, Poland

RECRUITING

Research Site 1626

Zamość, Poland

RECRUITING

Research Site 1803

Bacau, Romania

RECRUITING

Research Site 1805

Brasov, Romania

RECRUITING

Resarch Site 1801

Bucharest, Romania

RECRUITING

Research site 1802

Bucharest, Romania

RECRUITING

Research site 1804

Bucharest, Romania

RECRUITING

Research site 1303

Chisináu, Romania

RECRUITING

Research site 1806

Râmnicu Vâlcea, Romania

RECRUITING

Research site 1903

Belgrade, Serbia

RECRUITING

Research site 1904

Belgrade, Serbia

RECRUITING

Research site 1905

Belgrade, Serbia

RECRUITING

Research Site 1902

Novi Sad, Serbia

RECRUITING

Research site 1901

Zrenjanin, Serbia

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Central Study Contacts

Susana Millan, PhD

CONTACT

+34-917-711-500; Susana.Millan@mabxience.com

Amalia Flórez

CONTACT

+34-917-711-500; amalia.florez@mabxience.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: October 3, 2024
• Primary Completion: October 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-02

Locations

BU (8); PL (29); MO (2); RO (7); SE (5); GE (9)