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narsoplimab

Phase 2

Thrombotic Microangiopathies | Small molecule | Hematology |Omeros Corporation|Last Updated: Mar 25, 2025

Target and mechanism

Molecular targetMASP2
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL4298195

Also known as Biological: narsoplimab

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

narsoplimab · 1 trial · 2 indications

Phase 2 1
NCT05855083Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMAThrombotic Microangiopathies
RECRUITING18 Analytics
PHASE2RECRUITING
Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMA
Thrombotic Microangiopathies
NCT0585508318
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Study Endpoints

Primary Endpoints

100-day survival rate following high-risk HSCT-TMA diagnosis.
100 days

Percentage of patients alive at 100 days following the diagnosis of high-risk HSCT-TMA

Secondary Endpoints

Number of participants with treatment-emergent adverse events assessed by CTCAE v5.0
52 weeks
Percentage of patients meeting protocol definition of clinical response
52 weeks
52 week survival rate following high-risk HSCT-TMA diagnosis
52 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Narsoplimab single arm-treatmentEXPERIMENTALNarsoplimab 4 mg/kg

Interventions

NameTypeDescription
Biological: narsoplimabDRUGTreatment with narsoplimab 4 mg/kg will be administered
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Eligibility Criteria

Age Range28 Days to 17 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: 1. Age at least 28 days and less than 18 years prior to informed consent (Visit 0). 2. Have informed consent from at least one parent or legal guardian as required by local law and regulation. Patient informed consent will be required if the patient has reached the local legal a...

Countries:United StatesGermanyIsraelNetherlandsSpain
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