OM336 in Seropositive Autoimmune Diseases

November 13, 2025 updated by: Ouro Medicines

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

39

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OM336 Dose Escalation
Participants will receive OM336 via subcutaneous injection in ascending dose cohorts
Drug: OM336
OM336 is an engineered bispecific antibody directed against BCMA and CD3

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: 52 weeks
Incidence and severity of treatment-emergent adverse events (TEAEs)
52 weeks
To assess the pharmacokinetics (PK) of OM336
Time Frame: 12 weeks
Serum concentrations of OM336
12 weeks
Detection of anti-drug antibodies
Time Frame: 12 weeks
Detection of anti-drug antibodies
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ouro Medicines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Estimated)

November 14, 2025

Study Record Updates

Last Update Posted (Estimated)

November 14, 2025

Last Update Submitted That Met QC Criteria

November 13, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OM336-SAI-1002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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