Sjogrens DiseasePhase 1NCT07229144
OM336 in Seropositive Autoimmune Diseases
A Phase 1 study testing OM336 in people with Sjogrens Disease and Idiopathic Inflammatory Myopathy (IIM), run by Lakefront Biotherapeutics West LLC at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sjogrens Disease, Idiopathic Inflammatory Myopathy (IIM)
- What is being tested?
- OM336
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteNew Zealand
- Study dates
- 1 Oct 2025to Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
New Zealand1 site, 1 recruiting
- Recruiting
Waikato Hospital
Hamilton, Waikato Region, 3204
Primary Contact, (07) 839 8899, info@waikatodhb.health.nz
About this study
Official title: An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Sjogren's Disease or Idiopathic Inflammatory Myopathy
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.
Read the 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.
- Being tested
- OM336
- Keywords
- OM336, Ouro
- Medical subject headings
- Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OM336Drug
OM336 is an engineered bispecific antibody directed against BCMA and CD3
| Study group | Role | What they receive |
|---|---|---|
| OM336 Dose Escalation | Experimental | Participants will receive OM336 via subcutaneous injection in ascending dose cohorts Receives: Drug: OM336 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Incidence and severity of treatment-emergent adverse events (TEAEs)
Measured: 12 weeks
Secondary outcomes (3)
Safety and Tolerability
Incidence and severity of treatment-emergent adverse events (TEAEs)
Measured: 52 weeks
To assess the pharmacokinetics (PK) of OM336
Serum concentrations of OM336
Measured: 12 weeks
Detection of anti-drug antibodies
Detection of anti-drug antibodies
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start1 Oct 2025
- Primary completionJun 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogrens DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics West LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229144
- Sponsor's protocol ID
- OM336-SAI-1002
- Status last verified
- Jun 2026
- First submitted
- 13 Nov 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Sjogren's Disease or Idiopathic Inflammatory Myopathy
- ClinicalTrials.gov ID
- NCT07229144
- Acronym / sponsor ID
- OM336-SAI-1002
- Keywords
- OM336, Ouro
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Lakefront Biotherapeutics West LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OM336 Dose Escalation | Experimental | Drug: OM336Participants will receive OM336 via subcutaneous injection in ascending dose cohorts |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OM336OM336 is an engineered bispecific antibody directed against BCMA and CD3 | Drug | OM336 Dose Escalation |
Primary outcome
Safety and Tolerability
Time frame: 12 weeks
Incidence and severity of treatment-emergent adverse events (TEAEs)
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OM336 in people with Sjogrens Disease and Idiopathic Inflammatory Myopathy (IIM), run by Lakefront Biotherapeutics West LLC at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Sponsor (415-429-4887, clinical@ouromeds.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.