Clinical trial NCT06596772: A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Rheumatoid Arthritis (RA)
Keywords: Rheumatoid Arthritis
Lead sponsor: mAbxience Research S.L.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion

* 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 \&gt; 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\&#39;s discretion
* Agree to use highly effective contraceptive methods up to 6 months after las dose Exclusion
* 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\&#39;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

Primary outcomes:
measure: American College of Rheumatology 20% Response Criteria (ACR20)
timeFrame: Week 24
Secondary outcomes:
measure: ACR20
timeFrame: Weeks 36
measure: American College of Rheumatology 50% Response Criteria (ACR50)
timeFrame: Weeks 24 and 36
measure: American College of Rheumatology 70% Response Criteria (ACR70)
timeFrame: Weeks 24 and 36
Other outcomes:
Locations:
city: Haskovo
country: Bulgaria
facility: Research site 2007
city: Plovdiv
country: Bulgaria
facility: Research site 2005
city: Ruse
country: Bulgaria
facility: Research Site 2002
city: Sofia
country: Bulgaria
facility: Research site 2001
city: Sofia
country: Bulgaria
facility: Research Site 2003
city: Sofia
country: Bulgaria
facility: Research Site 2008
city: Vidin
country: Bulgaria
facility: Research site 2004
city: Vratsa
country: Bulgaria
facility: Research site 2006
city: Batumi
country: Georgia
facility: Research site 7004
city: Batumi
country: Georgia
facility: Research site 7010
city: Tbilisi
country: Georgia
facility: Research site 7001
city: Tbilisi
country: Georgia
facility: Research site 7002
city: Tbilisi
country: Georgia
facility: Research site 7003
city: Tbilisi
country: Georgia
facility: Research site 7005
city: Tbilisi
country: Georgia
facility: Research site 7006
city: Tbilisi
country: Georgia
facility: Research site 7007
city: Tbilisi
country: Georgia
facility: Research site 7009
city: Chișinău
country: Moldova, Republic of
facility: Research Site 1301
city: Chișinău
country: Moldova, Republic of
facility: Research site 1302
city: Bialystok
country: Poland
facility: Research Site 1614
city: Białystok
country: Poland
facility: Research Site 1603
city: Białystok
country: Poland
facility: Research site 1616
city: Bydgoszcz
country: Poland
facility: Research site 1613
city: Bytom
country: Poland
facility: Research site 1623
city: Elblag
country: Poland
facility: Research Site 1615
city: Elblag
country: Poland
facility: Research Site 1627
city: Gdynia
country: Poland
facility: Research Site 1606
city: Katowice
country: Poland
facility: Research Site 1611
city: Krakow
country: Poland
facility: Research Site 1617
city: Lublin
country: Poland
facility: Research Site 1622
city: Nowa Sól
country: Poland
facility: Research site 1605
city: Opole
country: Poland
facility: Research Site 1618
city: Piotrków Trybunalski
country: Poland
facility: Research site 1628
city: Poniatowa
country: Poland
facility: Research Site 1624
city: Poznan
country: Poland
facility: Resarch Site 1619
city: Poznan
country: Poland
facility: Research Site 1601
city: Poznan
country: Poland
facility: Research Site 1602
city: Poznan
country: Poland
facility: Research Site 1608
city: Poznan
country: Poland
facility: Research Site 1621
city: Siedlce
country: Poland
facility: Research Site 1612
city: Sochaczew
country: Poland
facility: Research Site 1610
city: Stalowa Wola
country: Poland
facility: Research site 1629
city: Torun
country: Poland
facility: Research Site 1620
city: Warszawa
country: Poland
facility: Research Site 1604
city: Warszawa
country: Poland
facility: Research Site 1607
city: Warszawa
country: Poland
facility: Research Site 1609
city: Wroclaw
country: Poland
facility: Research Site 1625
city: Zamość
country: Poland
facility: Research Site 1626
city: Bacau
country: Romania
facility: Research Site 1803
city: Brasov
country: Romania
facility: Research Site 1805
city: Bucuresti
country: Romania
facility: Resarch Site 1801
city: Bucuresti
country: Romania
facility: Research site 1802
city: Bucuresti
country: Romania
facility: Research site 1804
city: Chisináu
country: Romania
facility: Research site 1303
city: Râmnicu Vâlcea
country: Romania
facility: Research site 1806
city: Belgrade
country: Serbia
facility: Research site 1903
city: Belgrade
country: Serbia
facility: Research site 1904
city: Belgrade
country: Serbia
facility: Research site 1905
city: Novi Sad
country: Serbia
facility: Research Site 1902
city: Zrenjanin
country: Serbia
facility: Research site 1901
Study officials:
References: