OM336 in Seropositive Autoimmune Diseases

An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Sjogren's Disease or Idiopathic Inflammatory Myopathy

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.

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