RecruitingPhase 1NCT07229144

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

Sponsor

Lakefront Biotherapeutics West LLC

Enrollment

39 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Idiopathic Inflammatory Myopathy (IIM)Sjogrens Disease

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

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

Exclusion Criteria4

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

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Interventions

DRUGOM336

OM336 is an engineered bispecific antibody directed against BCMA and CD3

Locations(1)

Waikato Hospital

Hamilton, Waikato Region, New Zealand

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NCT07229144

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