NCT07229144Not yet recruitingPhase 1
An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Sjogren's Disease or Idiopathic Inflammatory Myopathy
Ouro Medicines0 sites39 target enrollmentStarted: November 1, 2025Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 39
- Primary Endpoint
- Safety and Tolerability
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
OM336 Dose Escalation
Experimental
Participants will receive OM336 via subcutaneous injection in ascending dose cohorts
Intervention: OM336 (Drug)
Outcomes
Primary Outcomes
Safety and Tolerability
Time Frame: 12 weeks
Incidence and severity of treatment-emergent adverse events (TEAEs)
Secondary Outcomes
- Safety and Tolerability(52 weeks)
- To assess the pharmacokinetics (PK) of OM336(12 weeks)
- Detection of anti-drug antibodies(12 weeks)
Investigators
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