NCT07229144

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
22mo left

Started Nov 2025

Typical duration for phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Nov 2025Mar 2028

Study Start

First participant enrolled

November 1, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

1.6 years

First QC Date

November 13, 2025

Last Update Submit

November 13, 2025

Conditions

Sjogrens DiseaseIdiopathic Inflammatory Myopathy (IIM)

Keywords

OM336Ouro

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

    Incidence and severity of treatment-emergent adverse events (TEAEs)

    12 weeks

Secondary Outcomes (3)

  • Safety and Tolerability

    52 weeks

  • To assess the pharmacokinetics (PK) of OM336

    12 weeks

  • Detection of anti-drug antibodies

    12 weeks

Study Arms (1)

OM336 Dose Escalation

EXPERIMENTAL

Participants will receive OM336 via subcutaneous injection in ascending dose cohorts

Drug: OM336

Interventions

OM336DRUG

OM336 is an engineered bispecific antibody directed against BCMA and CD3

OM336 Dose Escalation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myositis

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Study Sponsor

CONTACT

415-429-4887clinical@ouromeds.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 14, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

November 14, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share