A Phase 1 interventional study of OM336 in Sjogrens Disease and Idiopathic Inflammatory Myopathy (IIM), sponsored by Lakefront Biotherapeutics West LLC. Recruiting at 1 site in New Zealand. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Lakefront Biotherapeutics West LLC (part of Lakefront Biotherapeutics NV) · Phase 1, Interventional, and Treatment
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.
215 studies on the registry are indexed under Myositis; 100 are open to participants now.
This study's planned enrollment of 39 is above the median of 30 across 141 interventional studies indexed under Myositis.
Browse Myositis studies →Lakefront Biotherapeutics West LLC is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive OM336 via subcutaneous injection in ascending dose cohorts
Drug: OM336
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
Plan to share: No
No publications or documents are linked to this record.
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