Trials / Not Yet Recruiting
Not Yet RecruitingNCT07229144
OM336 in Seropositive Autoimmune Diseases
An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Sjogren's Disease or Idiopathic Inflammatory Myopathy
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (estimated)
- Sponsor
- Ouro Medicines · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OM336 | OM336 is an engineered bispecific antibody directed against BCMA and CD3 |
Timeline
- Start date
- 2025-11-01
- Primary completion
- 2027-06-01
- Completion
- 2028-03-01
- First posted
- 2025-11-14
- Last updated
- 2025-11-14
Source: ClinicalTrials.gov record NCT07229144. Inclusion in this directory is not an endorsement.