OM336 in Seropositive Autoimmune Diseases
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOuro Medicines
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Sequential
Treatments tested in this trial
OM336
DrugOM336 is an engineered bispecific antibody directed against BCMA and CD3
Treatment groups
39 Participants
are divided into 1 treatment groupGroup A: OM336 Dose EscalationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Tolerability
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame
12 weeksSecondary outcomes
1
Safety and Tolerability
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame
52 weeks2
To assess the pharmacokinetics (PK) of OM336
Serum concentrations of OM336
Time frame
12 weeks3
Detection of anti-drug antibodies
Detection of anti-drug antibodies
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov