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MEDI-507

Phase 2

Psoriasis | Small molecule | Immunology |AstraZeneca PLC|Last Updated: Oct 25, 2006

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00192452Study of MEDI-507 Administered by Intravenous Infusion to Adults With Plaque PsoriasisPHASE2 COMPLETED 120Mar 1, 2001Dec 1, 2001Oct 25, 20063 United States
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Study Endpoints
Primary Endpoints
Analyses of categorical data will be performed and analysis of continuous data will be performed using a one-way analysis of variance (ANOVA) with traetment group as a factor.
Secondary Endpoints
Percentage of subjects with at least 75% improvement and those with at least 50% improvement will be compared.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
MEDI-507DRUG -
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Plaque psoriasis involving at least 10% of body surface area (Appendix B) * Age 18 through 65 years at the time of the first dose of study drug * Both males and females are eligible. However, sexually active females, unless surgically sterile or at least 1 year post-menopausal...

Countries:United States
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