Recent Updates
Recently added Catalysts

BMO-2

Phase 1

Healthy Volunteers | Monoclonal antibody | Other |Viatris Inc.|Last Updated: Mar 11, 2022

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment270

FDA Designations

No designations recorded

Clinical trial landscape

BMO-2 · 1 trial · 1 indication

Phase 1 1
NCT02472912Adalimumab PK Bioequivalence Study to EU and US Sourced HumiraHealthy Volunteers
COMPLETED270 Analytics
PHASE1COMPLETED
Adalimumab PK Bioequivalence Study to EU and US Sourced Humira
Healthy Volunteers
NCT02472912270
Unlock trial analytics

Study Endpoints

Primary Endpoints

Area under the plasma concentration versus time curve (AUC) of adalimumab.
1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71 days post subcutaneous injection.

Secondary Endpoints

Frequency of Adverse Events
Up to 71 days.
Safey variable - Tolerability (injection site reactions)
Predose and 1, 2, 3, 7, 9, 36, and 71 days post subcutaneous injection.
Safety variable - immunogenicity (Presence of anti-adalimumab antibodies)
Day 1 (pre-dose) and Day 9, 29, and 71 days post subcutaneous injection.
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeHEALTH_SERVICES_RESEARCH

Treatment Arms

ArmTypeDescription
Treatment AEXPERIMENTALSingle Injection of 40mg / 0.8 mL BMO-2
Treatment BACTIVE_COMPARATORSingle Injection of 40mg / 0.8 mL EU-Humira
Treatment CACTIVE_COMPARATORSingle Injection of 40mg / 0.8 mL US-Humira

Interventions

NameTypeDescription
BMO-2BIOLOGICALVolunteers randomized in Treatment A will receive a single subcutaneous injection of BMO-2 (40mg / 0.8mL).
EU-HumiraBIOLOGICALVolunteers randomized in Treatment B will receive a single subcutaneous injection of EU-Sourced Humira (40 mg / 0/8 mL)
US-HumiraBIOLOGICALVolunteers randomized in Treatment C, will receive a single subcutaneous injection of US-sourced Humira (40 mg / 0.8 mL).
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Weight: 60.0-95.0 kg. * Body mass index (BMI) : 19.0-30.0 kg/m2, inclusive * Medical history without major pathology. * Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg. * Computerized (12-lead) electrocardiogram (ECG) recording without signs of clinical...

Countries:Belgium
Unlock Eligibility Criteria

Frequently asked questions about BMO-2

What is BMO-2?

BMO-2 is an investigational monoclonal antibody being developed by Viatris Inc. (ticker: VTRS). It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers, with a completed trial that enrolled 270 participants.

What is BMO-2 used for?

BMO-2 is being studied for use in healthy volunteers. The completed Phase 1 trial was a pharmacokinetic bioequivalence study comparing BMO-2 to EU and US sourced Humira (adalimumab). The drug is intended for use in healthy volunteers as part of this clinical investigation.

Who makes BMO-2?

BMO-2 is being developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker VTRS. Viatris is conducting clinical trials for BMO-2, which is an investigational monoclonal antibody currently in Phase 1 development.

What phase is BMO-2 in?

BMO-2 is in Phase 1 clinical development. The drug has completed one Phase 1 trial, which was a randomized, double-blind, active-controlled study. BMO-2 is still investigational and has not been approved by regulatory authorities.

What clinical trials is BMO-2 in?

BMO-2 has one completed clinical trial, identified as NCT02472912. This Phase 1 study was a pharmacokinetic bioequivalence trial comparing BMO-2 to EU and US sourced Humira in healthy volunteers. The trial enrolled 270 participants and was conducted in Belgium.

Is BMO-2 the same as Humira?

BMO-2 is not the same as Humira, but it is being studied as a potential biosimilar. The completed Phase 1 trial was designed to assess the pharmacokinetic bioequivalence of BMO-2 compared to EU and US sourced Humira (adalimumab). BMO-2 is an investigational monoclonal antibody.