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B. Infantis 35624

Phase 1

Psoriasis | Unknown | Immunology |Smith & Nephew SNATS, Inc.|Last Updated: Oct 13, 2011

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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment47
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01451346Study in Patients With Mild to Moderate PsoriasisPHASE1 COMPLETED 47Jan 1, 2008Aug 1, 2011Oct 13, 20111 Ireland
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Study Endpoints
Primary Endpoints
Change in the Psoriasis area and severity index between baseline and end of feeding
At 12 weeks

The PASI score stands for Psoriasis Area and Severity Index. This tool allows researchers to put an objective number on what would otherwise be a very subjective idea: how bad is a person's psoriasis. To make up the score, the three features of a psoriatic plaque (redness) scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. Then the extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72

Secondary Endpoints
Psoriasis Disability Index[PDI}
at 12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo sachets contained 5 grams of Maltodextrin only.
B Infantis 35624EXPERIMENTALEach 5gram freeze-dried powder contained ≥1\*1010 Colony forming units (CFU) of B. infantis 35624/sachet.
Interventions
NameTypeDescription
B. Infantis 35624DIETARY_SUPPLEMENTOne sachet daily for 12 weeks
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects diagnosed with mild to moderate psoriasis as defined by the clinician, * Has a Psoriasis Area and Severity Index{PASI} of less than 20, * Male or female subjects, * Aged between 18-60 years of age, * Non-pregnant female and must agree to use adequate method of contrac...

Countries:Ireland
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