Sjogrens Disease, Idiopathic Inflammatory Myopathy (IIM)
Conditions
Keywords
OM336, Ouro
Brief summary
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.
Detailed description
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.
Interventions
DRUGOM336
OM336 is an engineered bispecific antibody directed against BCMA and CD3
Sponsors
Ouro Medicines
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Diagnosis of active seropositive autoimmune disease * Relapsed/refractory after ≥2 prior/ongoing treatments * Body weight ≥ 50 kg * Willing to comply with and study requirements and procedures Key
Exclusion criteria
* Previous treatment with a BCMA-targeted therapy * Clinically significant infection within 3 months of screening * Major surgery within 3 months of screening or planned during the study * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | 12 weeks | Incidence and severity of treatment-emergent adverse events (TEAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | 52 weeks | Incidence and severity of treatment-emergent adverse events (TEAEs) |
| To assess the pharmacokinetics (PK) of OM336 | 12 weeks | Serum concentrations of OM336 |
| Detection of anti-drug antibodies | 12 weeks | Detection of anti-drug antibodies |
Contacts
Primary ContactStudy Sponsor
Outcome results
None listed