Trials / Recruiting
RecruitingNCT07083960
OM336 in Autoimmune Cytopenias
An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Autoimmune Cytopenias
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (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 subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.
Detailed description
An open-label, multicenter, ascending dose study, evaluating safety, tolerability, and PK/ADA of OM336 in autoimmune cytopenias.
Conditions
- AIHA - Warm Autoimmune Hemolytic Anemia
- AIHA - Cold Autoimmune Hemolytic Anemia
- ITP - Immune Thrombocytopenia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OM336 | OM336 is an engineered bispecific antibody directed against BCMA and CD3 |
Timeline
- Start date
- 2025-08-01
- Primary completion
- 2026-12-01
- Completion
- 2027-09-01
- First posted
- 2025-07-24
- Last updated
- 2025-09-30
Locations
3 sites across 1 country: Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07083960. Inclusion in this directory is not an endorsement.