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AP611074 5%

Phase 2

Condyloma | Small Molecules | Other |Vaxart, Inc|Trials Updated: Jul 20, 2018

AP611074 5% target and mechanism

ModalitySmall Molecules

Also known as AP611074 5% gel

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment218

FDA Designations

No designations recorded

AP611074 5% clinical trials

AP611074 5% · 1 trial · 1 indication

Phase 2 1
NCT02724254A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Topical Applications of AP611074 5% Gel for up to 16 Weeks in Condyloma PatientsCondyloma
COMPLETED218 Analytics
PHASE2COMPLETED
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Topical Applications of AP611074 5% Gel for up to 16 Weeks in Condyloma Patients
Condyloma
NCT02724254218
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Study Endpoints

Primary Endpoints

Percentage of patients with at least one local skin reaction (LSR)
Day 0 to Week 16
Number of patients experiencing adverse events
Day 0 to Week 16
Mean plasma concentrations of AP611074-04
Day 0 to 2 weeks post end of treatment

Secondary Endpoints

Proportion of subjects with a complete clearance rate (100%) for baseline genital wart lesions
Day 0 to week 16
Reduction in the total condyloma area for lesions
Day 0 to week 16
Proportion of subjects with a complete clearance rate (100%) for all genital wart lesions
Day 0 to week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AP611074 5% gelEXPERIMENTAL100 mg twice daily doses of AP611074 5% gel
PlaceboPLACEBO_COMPARATORAP611074 matching placebo gel

Interventions

NameTypeDescription
AP611074 5% gelDRUG -
AP611074 matching placeboDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: 1. Male or female patient aged between 18 and 55 years. 2. External condylomas, 2-30 lesions (no more than 2 lesions side by side); flat or papular, but not pediculated. 3. Lesions must not be internal. Lesions that originate internally, but are visible externally will be consid...

Countries:ArgentinaChileEcuadorSerbia
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