OM336 in Seropositive Autoimmune Diseases | NCT07229144

Studies
OM336 in Seropositive Autoimmune Diseases

NCT07229144

Sponsor

Ouro Medicines

Status

Recruiting

Last Update Posted

Jun 15, 2026Actual

Enrollment

39Estimated

Phase

Phase 1

Conditions

Sjogrens Disease
Idiopathic Inflammatory Myopathy (IIM)

Interventions

OM336

Countries

New Zealand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2025Actual

Primary Completion Date

Jun 2027Estimated

Completion Date

Mar 2028Estimated

First Submitted Date

Nov 13, 2025

First Submission Date that Met QC Criteria

Nov 13, 2025

First Posted Date

Nov 14, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2026

Last Update Posted Date

Jun 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OM336 Dose Escalation	Experimental	Participants will receive OM336 via subcutaneous injection in ascending dose cohorts	Drug: OM336

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OM336	Drug	OM336 is an engineered bispecific antibody directed against BCMA and CD3	OM336 Dose Escalation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and Tolerability	Incidence and severity of treatment-emergent adverse events (TEAEs)	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Safety and Tolerability	Incidence and severity of treatment-emergent adverse events (TEAEs)	52 weeks
To assess the pharmacokinetics (PK) of OM336	Serum concentrations of OM336

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Study Sponsor	Contact	415-429-4887		clinical@ouromeds.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Waikato Hospital	Recruiting	Hamilton	Waikato Region	3204	New Zealand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009220	Myositis

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided