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Baminercept alfa 1

Phase 2

Rheumatoid Arthritis | Monoclonal antibody | Immunology |Biogen Inc.|Trials Updated: Jan 21, 2016

Baminercept alfa 1 development status

Highest phase Phase 2
Registered trials 4 across 1 sponsor since Feb 2006

Baminercept alfa 1 target and mechanism

Molecular targetLTA, LTB, TNFSF14
Target classInhibitor
ModalityMonoclonal antibody

Also known as BG9924, LT beta

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment441

FDA Designations

No designations recorded

Baminercept alfa 1 clinical trials

Baminercept alfa 1 · 2 trials · 1 indication

Phase 2 2
NCT00664716Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) ParticipantsRheumatoid Arthritis
COMPLETED391 Analytics
NCT00292422Dose-Escalating Study of BG9924 in Combination With Methotrexate in Active Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED50 Analytics
PHASE2COMPLETED
Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Participants
Rheumatoid ArthritisUnlock trial analytics
PHASE2COMPLETED
Dose-Escalating Study of BG9924 in Combination With Methotrexate in Active Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate efficacy of BG9924 in combination with methotrexate (MTX) in RA participants who have had an inadequate response to DMARD therapy
3 months
To evaluate the safety and tolerability of BG9924 when administered in combination with MTX to subjects with active RA who have had an inadequate response to DMARD therapy

Secondary Endpoints

Assess the safety and tolerability of BG9924 in this participant population
3 months
To assess the pharmacokinetics and pharmacodynamics of multiple doses of BG9924 in this patient population
To assess the preliminary efficacy of multiple doses of BG9924 in this patient population
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORsubcutaneous administration of placebo given for 12 weeks
One DoseEXPERIMENTALBG9924 - dosage level administered as per Biogen Idec protocol
Second DoseEXPERIMENTALBG9924 - dosage level administered as per Biogen Idec protocol
Third DoseEXPERIMENTALBG9924 - dosage level administered as per Biogen Idec protocol
Fourth DoseEXPERIMENTALBG9924 - dosage level administered as per Biogen Idec protocol
Fifth DoseEXPERIMENTALBG9924 - dosage level administered as per Biogen Idec protocol

Interventions

NameTypeDescription
Baminercept alfa 1BIOLOGICALexperimental - one dose level
PlaceboBIOLOGICALPlacebo comparator
Baminercept alfa 2BIOLOGICALexperimental - second dose level
Baminercept alfa 3BIOLOGICALexperimental - third dose level
Baminercept alfa 4BIOLOGICALexperimental - fourth dose level
Baminercept alfa 5BIOLOGICALexperimental - fifth dose level
BG9924DRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites8

Key Inclusion Criteria: * Diagnosis of RA (functional class I - III) * Stable dose of MTX * Inadequate response to at least one conventional DMARD therapy Key Exclusion Criteria: * Serious local infection or systemic infection * History (Hx) of recurrent infections requiring oral or parenteral an...

Countries:ArgentinaBrazilHungaryMexicoPolandRomaniaRussiaUnited KingdomUnited States
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Frequently asked questions about Baminercept alfa 1

What is Baminercept alfa 1 used for?

Baminercept alfa 1 is an investigational therapy being studied for the treatment of rheumatoid arthritis, an autoimmune condition that causes joint inflammation. It is not yet approved for any indication and remains in clinical development. The Phase 2 trial evaluated its safety and efficacy in adults with rheumatoid arthritis.

What does Baminercept alfa 1 target?

Baminercept alfa 1 targets LTA, LTB, and TNFSF14, which are members of the lymphotoxin and tumor necrosis factor superfamilies. By inhibiting these targets, the drug is designed to modulate immune pathways involved in inflammation. This mechanism is being explored for its potential to reduce disease activity in rheumatoid arthritis.

Who is developing Baminercept alfa 1?

Baminercept alfa 1 is being developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen is a biotechnology company focused on neurological and immunological diseases. The company sponsored the Phase 2 clinical trial of this asset.

What phase is Baminercept alfa 1 in?

Baminercept alfa 1 is in Phase 2 clinical development. The only reported trial was a Phase 2 study that has been completed. There are currently no active trials listed for this drug. It is not approved by the FDA or any regulatory agency for any indication.

What clinical trials is Baminercept alfa 1 in?

Baminercept alfa 1 has been studied in one completed Phase 2 trial, NCT00664716, titled Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Participants. The trial enrolled 391 adults with rheumatoid arthritis across Argentina, Brazil, Hungary, Mexico, Poland, Romania, Russia, and the United Kingdom.

Is Baminercept alfa 1 the same as BG9924?

Yes, Baminercept alfa 1 is also known as BG9924. The Phase 2 trial for rheumatoid arthritis was conducted under the name BG9924. Both names refer to the same investigational monoclonal antibody developed by Biogen.