An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of OM336 in adult participants with seropositive autoimmune diseases. OM336 is administered subcutaneously in ascending dose cohorts.
An open-label, multicenter, multiple ascending dose study evaluating safety, tolerability, and PK/ADA profile of OM336 in seropositive autoimmune diseases. Exploratory assessments include clinical response and biomarkers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
OM336 is an engineered bispecific antibody directed against BCMA and CD3
Safety and Tolerability
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: 12 weeks
Safety and Tolerability
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: 52 weeks
To assess the pharmacokinetics (PK) of OM336
Serum concentrations of OM336
Time frame: 12 weeks
Detection of anti-drug antibodies
Detection of anti-drug antibodies
Time frame: 12 weeks
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