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BG9924

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Biogen Inc.|Trials Updated: Jan 21, 2016

BG9924 development status

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

BG9924 target and mechanism

Molecular targetLTßR
Target classReceptor
ModalitySmall molecule

Also known as Baminercept alfa 1, LT beta, Baminercept alfa 2, Baminercept alfa 3, Baminercept alfa 4, Baminercept alfa 5, Baminercept alfa (BG9924), Baminercept alfa

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment441

FDA Designations

No designations recorded

BG9924 clinical trials

BG9924 · 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 BG9924

What is BG9924?

BG9924 is an investigational small molecule developed by Biogen Inc. (ticker BIIB) for the treatment of rheumatoid arthritis. It is a Phase 2 drug candidate in the immunology therapeutic area. It has been studied in combination with methotrexate in adults with active rheumatoid arthritis.

What is BG9924 used for in rheumatoid arthritis?

BG9924 is being developed for rheumatoid arthritis, an inflammatory joint disease. The clinical program studied BG9924 in combination with methotrexate in adults aged 18 years and older with active rheumatoid arthritis. It is investigational and has not been established as a marketed treatment.

What does BG9924 target?

BG9924 targets LT beta receptor, also known as LTßR, a cell surface receptor. LTßR is the molecular target of this small molecule. Targeting this receptor places BG9924 in the immunology space, where it was evaluated for rheumatoid arthritis in combination with methotrexate.

Who makes BG9924?

BG9924 is developed by Biogen Inc., which trades under the ticker BIIB. Biogen sponsored the clinical program for BG9924, including the Phase 2 study conducted in the United States and Poland in patients with active rheumatoid arthritis.

What phase is BG9924 in?

BG9924 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The completed study was a randomized, double-blind, dose-escalating Phase 2 trial of BG9924 in combination with methotrexate in active rheumatoid arthritis.

What clinical trials is BG9924 in?

BG9924 has been studied in one Phase 2 trial, NCT00292422, titled Dose-Escalating Study of BG9924 in Combination With Methotrexate in Active Rheumatoid Arthritis. The trial enrolled 50 participants, was randomized and double-blind, and was conducted in the United States and Poland. It is now completed.