OM336 in seropositive autoimmune diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multicenter, Phase 1 trial evaluating safety, tolerability, and pharmacokinetics of OM336 in adults with seropositive autoimmune diseases such as Sjögren’s disease and idiopathic inflammatory myopathy. Participants receive ascending doses of OM336 subcutaneously, with ongoing monitoring for adverse events and immune responses. Exploratory assessments will look at clinical signals of response and biomarker changes to guide future research. The study helps establish initial safety data and PK/ADA profiles in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• Waikato Hospital
  Hamilton, Waikato Region, New Zealand Recruiting

Study contacts

• Study coordinator: Study Sponsor
• Email: clinical@ouromeds.com
• Phone: 415-429-4887

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.