OM336 in Seropositive Autoimmune Diseases

NCT ID: NCT07229144

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2028-03-31

Brief Summary

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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

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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.

Conditions

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Sjogrens Disease Idiopathic Inflammatory Myopathy (IIM)

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OM336 Dose Escalation

Participants will receive OM336 via subcutaneous injection in ascending dose cohorts

Group Type EXPERIMENTAL

OM336

Intervention Type DRUG

OM336 is an engineered bispecific antibody directed against BCMA and CD3

Interventions

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OM336

OM336 is an engineered bispecific antibody directed against BCMA and CD3

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ouro Medicines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Study Sponsor

Role: CONTACT

415-429-4887

Other Identifiers

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OM336-SAI-1002

Identifier Type: -

Identifier Source: org_study_id

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