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GSK1358820

Phase 3

Hyperhidrosis | Small molecule | Other |GSK plc|Last Updated: Jun 8, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment152
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01128738GSK1358820 (Botulinum Toxin A) PhIII DB & OL Study in Patients With Axillary HyperhidrosisPHASE3 COMPLETED 152 — — Apr 1, 2010Aug 1, 2011Jun 8, 201514 Japan
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Study Endpoints
Primary Endpoints
Percentage of Responders Assessed by Gravimetric Measurement at Week 4 in the First Treatment Phase
Week 4

A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating.

Secondary Endpoints
Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase
Weeks 1, 8 ,12, 16, 20, and 24
Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase
Week 0 (Baseline); Weeks 1, 4, 8, 12, 16, 20, and 24
Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase
Week 0 (Baseline); and Weeks 1, 4, 8, 12, 16, 20, and 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GSK1358820ACTIVE_COMPARATOROnabotulinum toxin type A
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
GSK1358820DRUGOnabotulinum toxin type A
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range20 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: \<At start of the screening phase (Visit 1)\> * At least 50 mg of spontaneous resting axillary sweat production in each axilla measured gravimetrically at room temperature/humidity (20 - 25.6°C/20-80%) over a period of 5 minutes. (Patients should be at rest for at least 30 minu...

Countries:Japan
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