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CINRYZE

Phase 2

Hereditary Angioedema | Monoclonal antibody | Other |Takeda Pharmaceutical Company Limited|Last Updated: Jul 19, 2021

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
RandomizedCONTROLLED
Total Trials2
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01426763A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human HyaluronidasePHASE2 COMPLETED 12 — — Sep 12, 2011Nov 28, 2011Jul 19, 20214 United States
NCT01095497A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE AdministrationPHASE2 COMPLETED 26 — — Jun 7, 2010Dec 16, 2010Jul 9, 20217 United States
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Study Endpoints
Primary Endpoints
Incidence and Severity of Adverse Events, Number of Participants With Local Injection Site Reactions, and Number of Participants Who Discontinue Study Drug or Withdraw From the Study
18 days
Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.
18 days in each treatment period
Secondary Endpoints
Mean Change C1 Inhibitor (C1INH)
18 days
Mean Change C4 Compliment
18 days
Number of Subjects With C1 INH Antibodies
Day 1 (pre-dose), Day 18 (168 h post Dose 4), and 30 (±2) days after the last dose of study drug (Dose 4)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
SC CINRYZE with rHuPH20 Dose Level 1EXPERIMENTALSubcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks
SC CINRYZE with rHuPH20 Dose Level 2EXPERIMENTALSubcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
IV CINRYZE First, Then SC CINRYZE Dose 1EXPERIMENTAL -
IV CINRYZE First, Then SC CINRYZE Dose 2EXPERIMENTAL -
Interventions
NameTypeDescription
CINRYZE with rHuPH20BIOLOGICAL -
CINRYZEBIOLOGICALC1 esterase inhibitor (human)
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: To be eligible for this protocol, a subject must: 1. Provide informed consent/assent, as appropriate. 2. Have previously participated in CINRYZE Study 0624-200 and completed the subcutaneous therapy period in that study. 3. During the 3 consecutive months prior to screening, ha...

Countries:United States
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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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