OM336 in Seropositive Autoimmune Diseases

Ouro Medicines

Status and phase: Not yet enrolling; Phase 1

Conditions: Sjogrens Disease; Idiopathic Inflammatory Myopathy (IIM)

Treatments: Drug: OM336

Study type: Interventional

Funder types: Industry

Identifiers

NCT07229144

OM336-SAI-1002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

39 participants in 1 patient group

OM336 Dose Escalation

Experimental group

Description:

Participants will receive OM336 via subcutaneous injection in ascending dose cohorts

Treatment:

Drug: OM336