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dalazatide

Phase 1

Plaque Psoriasis | Small molecule | Immunology |TuHURA Biosciences, Inc.|Last Updated: May 6, 2015

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 Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02435342A 4 Week Study of the Safety, Tolerability, and Pharmacodynamics of ShK-186 (Dalazatide) in Active Plaque PsoriasisPHASE1 COMPLETED 24Oct 1, 2014Mar 1, 2015May 6, 20151 Canada
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Study Endpoints
Primary Endpoints
Subjects with adverse events
From randomization through Day 57 (12 timepoints)
Secondary Endpoints
Target lesion assessment
From randomization to Day 57 (4 timepoints)
Psoriasis Area Severity Index (PASI) score
From randomization to Day 57 (4 timepoints)
Patient and Investigator Global Assessment of Psoriasis
From randomization to Day 57 (4 timepoints)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
30ug dalazatideEXPERIMENTAL12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.
60ug dalazatideEXPERIMENTAL12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.
Interventions
NameTypeDescription
dalazatideDRUGSubcutaneous injection twice per week for a total of 9 doses, followed by four weeks of follow-up.
placeboDRUGplacebo, Subcutaneous injection twice per week for a total of 9 doses
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Adult male and female subjects, ages 18-65; 2. Active plaque psoriasis with ≥3% BSA involved; 3. An adequate number of vulgar psoriatic plaques of at least 2 cm X 2 cm with Target Lesion Investigator Global Assessment scores \>3, that are not located on the face, scalp, groin...

Countries:Canada
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