NCT06596772View on ClinicalTrials.gov

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

PHASE3RecruitingINTERVENTIONAL
Enrollment

458

Participants

Timeline

Start Date

October 3, 2024

Primary Completion Date

October 31, 2025

Study Completion Date

January 31, 2026

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

Trial Locations (60)

Unknown

RECRUITING

Research site 2007, Haskovo

RECRUITING

Research site 2005, Plovdiv

RECRUITING

Research Site 2002, Rousse

RECRUITING

Research site 2001, Sofia

RECRUITING

Research Site 2003, Sofia

RECRUITING

Research Site 2008, Sofia

RECRUITING

Research site 2004, Vidin

RECRUITING

Research site 2006, Vratsa

RECRUITING

Research site 7004, Batumi

RECRUITING

Research site 7010, Batumi

RECRUITING

Research site 7001, Tbilisi

RECRUITING

Research site 7002, Tbilisi

RECRUITING

Research site 7003, Tbilisi

RECRUITING

Research site 7005, Tbilisi

RECRUITING

Research site 7006, Tbilisi

RECRUITING

Research site 7007, Tbilisi

RECRUITING

Research site 7009, Tbilisi

RECRUITING

Research Site 1603, Bialystok

RECRUITING

Research Site 1614, Bialystok

RECRUITING

Research site 1616, Bialystok

RECRUITING

Research site 1613, Bydgoszcz

RECRUITING

Research site 1623, Bytom

RECRUITING

Research Site 1615, Elblag

RECRUITING

Research Site 1627, Elblag

RECRUITING

Research Site 1606, Gdynia

RECRUITING

Research Site 1611, Katowice

RECRUITING

Research Site 1617, Krakow

RECRUITING

Research Site 1622, Lublin

RECRUITING

Research site 1605, Nowa Sól

RECRUITING

Research Site 1618, Opole

RECRUITING

Research site 1628, Piotrkow Trybunalski

RECRUITING

Research Site 1624, Poniatowa

RECRUITING

Resarch Site 1619, Poznan

RECRUITING

Research Site 1601, Poznan

RECRUITING

Research Site 1602, Poznan

RECRUITING

Research Site 1608, Poznan

RECRUITING

Research Site 1621, Poznan

RECRUITING

Research Site 1612, Siedlce

RECRUITING

Research Site 1610, Sochaczew

RECRUITING

Research site 1629, Stalowa Wola

RECRUITING

Research Site 1620, Torun

RECRUITING

Research Site 1604, Warsaw

RECRUITING

Research Site 1607, Warsaw

RECRUITING

Research Site 1609, Warsaw

RECRUITING

Research Site 1625, Wroclaw

RECRUITING

Research Site 1626, Zamość

RECRUITING

Research Site 1803, Bacau

RECRUITING

Research Site 1805, Brasov

RECRUITING

Resarch Site 1801, Bucharest

RECRUITING

Research site 1802, Bucharest

RECRUITING

Research site 1804, Bucharest

RECRUITING

Research site 1303, Chisináu

RECRUITING

Research site 1806, Râmnicu Vâlcea

RECRUITING

Research site 1903, Belgrade

RECRUITING

Research site 1904, Belgrade

RECRUITING

Research site 1905, Belgrade

RECRUITING

Research Site 1902, Novi Sad

RECRUITING

Research site 1901, Zrenjanin

MD-2068

RECRUITING

Research Site 1301, Chisinau

MD2025

RECRUITING

Research site 1302, Chisinau

All Listed Sponsors
lead

mAbxience Research S.L.

INDUSTRY

NCT06596772 - A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter