OM336 in Seropositive Autoimmune Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OM336.
- Who it may be relevant to
- Registry conditions: Sjogrens Disease, Idiopathic Inflammatory Myopathy (IIM). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- New Zealand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Sjogren's Disease or Idiopathic Inflammatory Myopathy
Overview
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
- Drug OM336
OM336 is an engineered bispecific antibody directed against BCMA and CD3
Primary outcome measures
- Safety and Tolerability [Time frame: 12 weeks]
Secondary outcome measures (3)
- Safety and Tolerability [Time frame: 52 weeks]
- To assess the pharmacokinetics (PK) of OM336 [Time frame: 12 weeks]
- Detection of anti-drug antibodies [Time frame: 12 weeks]
Eligibility criteria
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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
New Zealand · 1 center
- Waikato Hospital — Hamilton
Identifiers
NCT: NCT07229144 · OM336-SAI-1002