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ICI 182,780

Phase 2

Systemic Lupus Erythematosus | Small molecule | Immunology |AstraZeneca PLC|Last Updated: Sep 22, 2009

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00417430Efficacy of Faslodex in Treatment of SLE Clinical, Serologic, and Molecular StudiesPHASE2 COMPLETED 20Sep 1, 2004Dec 1, 2006Sep 22, 20091 United States
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Study Endpoints
Primary Endpoints
Improved SLEDAI
Improved Disease Lab parameters
Measurement of the estrogen receptors from start to finish
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
ICI 182,780 (Faslodex)DRUG -
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Eligibility Criteria
Age Range16 Years — 50 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Premenopausal women with SLE * Without life-threatening manifestations * With regular menstrual cyles not on hormones of any kind Exclusion Criteria: For any of the following: * Increase of SLEDAI greater than 12 * If life-threatening manifestations occur * If menstruation ...

Countries:United States
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