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STAR-0215

Phase 2

Hereditary Angioedema | Small molecule | Other |Astria Therapeutics, Inc.|Last Updated: Jul 23, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment97
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06007677A Long-term Study of STAR-0215 in Participants With Hereditary AngioedemaPHASE2 ACTIVE NOT_RECRUITING 56 — — Sep 26, 2023Mar 1, 2031Jul 23, 202522 United States, Bulgaria +5
NCT05477160A Study of STAR-0215 in Healthy Adult ParticipantsPHASE1 COMPLETED 41 — — Jul 27, 2022Nov 17, 2023Jan 11, 20241 United States
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Study Endpoints
Primary Endpoints
Number of Participants Experiencing Treatment-emergent Adverse Events
Day 1 through study completion, an average of 6 years
Secondary Endpoints
Change From Baseline in Monthly HAE Attack Rate
Day 1, up to 5 years
Severity of HAE Attacks Experienced by Participants
Day 1 through up to 5 years
Duration of HAE Attacks
Day 1 through up to 5 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Regimen 1 (Arm A): STAR-0215EXPERIMENTALParticipants will receive STAR-0215 every 3 months.
Dose Regimen 2 (Arm B): STAR-0215EXPERIMENTALParticipants will receive STAR-0215 every 6 months.
Dose Regimen 1 (Arm C): STAR-0215EXPERIMENTALSTAR-0215 will be administered as a subcutaneous injection.
Dose Regimen 3 (Arm D): STAR-0215EXPERIMENTALSTAR-0215 will be administered as a subcutaneous injection.
STAR-0215 Dose 1EXPERIMENTALParticipants will be randomized to receive STAR-0215 or placebo.
STAR-0215 Dose 2EXPERIMENTALParticipants will be randomized to receive STAR-0215 or placebo.
STAR-0215 Dose 3EXPERIMENTALParticipants will be randomized to receive STAR-0215 or placebo.
STAR-0215 Dose 4EXPERIMENTALParticipants will be randomized to receive STAR-0215 or placebo.
STAR-0215 Dose 5EXPERIMENTALParticipants will be randomized to receive STAR-0215 or placebo.
Interventions
NameTypeDescription
STAR-0215DRUGSTAR-0215 will be administered as a subcutaneous injection.
STAR-0215 (SC)DRUGSTAR-0215 will be administered as an SC bolus injection.
Placebo (SC)DRUGPlacebo will be administered as an SC bolus injection.
STAR-0215 (IV)DRUGSTAR-0215 will be administered as an IV bolus injection.
Placebo (IV)DRUGPlacebo will be administered as an IV bolus injection.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Open to participants from STAR-0215-201 (NCT05695248) who have met one of the following conditions: * Completed STAR-0215-201 (follow up through 6 months after their last dose); * Eligible for STAR-0215-201 and entered the Run-In period but did not qualify for the Treatme...

Countries:United StatesBulgariaCanadaCzechiaGermanyPolandUnited Kingdom
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Competitive Landscape -Hereditary Angioedema 10 trials
CompanyTickerTrialsLead PhaseDrugs
Intellia Therapeutics, Inc.NTLA3PHASE3NTLA-2002, Normal Saline Administration, Biological NTLA-2002
BioCryst Pharmaceuticals, Inc.BCRX2PHASE3Berotralstat, berotralstat
Ionis Pharmaceuticals, Inc.IONS1PHASE3Donidalorsen
KalVista Pharmaceuticals, Inc.KALV1PHASE3KVD900, Drug: KVD900
Pharvaris N.V.PHVS1PHASE2deucrictibant
BioMarin Pharmaceutical Inc.BMRN1PHASE1Dose 1 of BMN 331
Astria Therapeutics, Inc.ATXS1PHASE2STAR-0215
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06007677primaryCompletionDate: changed
LOWMay 24, 2026NCT06007677studyFirstPostDate: changed