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REGN668

Phase 1

Dermatitis | Monoclonal antibody | Dermatology |Regeneron Pharmaceuticals, Inc.|Last Updated: Oct 4, 2012

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 Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01259323Sequential Ascending Dose Study to Assess the Safety and Tolerability of REGN668 (SAR231893) in Patients With Atopic DermatitisPHASE1 COMPLETED 30Dec 1, 2010Jul 1, 2012Oct 4, 201210 United States
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Study Endpoints
Primary Endpoints
The primary endpoint in the study is the incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN668 or Placebo from baseline through week 12.
12 weeks
Secondary Endpoints
The secondary endpoint is to characterize PK profile of study drug REGN668 from baseline through week 12.
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTAL -
Cohort 2EXPERIMENTAL -
Cohort 3EXPERIMENTAL -
Interventions
NameTypeDescription
REGN668BIOLOGICALDose 1: REGN668 or placebo
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Clinical diagnosis of atopic dermatitis that has been present for at least 3 years before the screening visit * Investigator's Global Assessment (IGA) score of \>/= 3 at the screening and baseline visits * \>/= 15% body surface area (BSA) of AD involvement at the screening and...

Countries:United States
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