A Double-blind Placebo Controlled, Randomized, Phase II 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

Vaxart2 sites in 2 countries218 target enrollmentJanuary 2016

ConditionsCondyloma

InterventionsAP611074 5% gel AP611074 matching placebo

DrugsAP611074 5% gel AP611074 matching placebo

Overview

Phase: Phase 2
Intervention: AP611074 5% gel
Conditions: Condyloma
Sponsor: Vaxart
Enrollment: 218
Locations: 2
Primary Endpoint: Percentage of patients with at least one local skin reaction (LSR)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a double-blind placebo controlled, randomized, phase 2 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

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

July 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vaxart

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patient aged between 18 and 55 years.
•External condylomas, 2-30 lesions (no more than 2 lesions side by side); flat or papular, but not pediculated.
•Lesions must not be internal. Lesions that originate internally, but are visible externally will be considered internal and are not allowed in the study.
•Total wart area (diameter x diameter) should not be less than 10mm2 and not more than 800 mm2
•Individual wart area should not measure more than 50mm2, and the major perpendicular diameter should not measure more than 10mm (1cm).
•Lesions to be treated should have appeared between 1 to 6 months before screening, and patients should not have received any previous condyloma treatment during the last 2 months before enrollment.
•For female patients: either postmenopausal, taking adequate contraceptive method or surgically sterile.

Exclusion Criteria

•Patients should not have received genital wart treatment for previous condylomas (other than the prior treatment for current condylomas referred at inclusion criteria) in the last 12 months before enrollment
•Patients with any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease, transplanted or immunosuppressed patients or other clinical condition that, in the Investigator's judgment, prevents the patients from participating to the study.
•Patients with any clinically significant abnormality following review of screening laboratory tests, vital signs, full physical examination and ECG.
•Patients with history or presence of drug or alcohol abuse.
•Patients with positive HBs or HBc antigen or anti HCV antibody, or positive results for HIV 1 or 2 tests.
•Patients using any dermatological drug therapy in the treatment area during the last month prior the first application of the study drug.

Arms & Interventions

AP611074 5% gel

100 mg twice daily doses of AP611074 5% gel

Intervention: AP611074 5% gel

Placebo

AP611074 matching placebo gel

Intervention: AP611074 matching placebo

Outcomes

Primary Outcomes

Percentage of patients with at least one local skin reaction (LSR)

Time Frame: Day 0 to Week 16

Mean plasma concentrations of AP611074-04

Time Frame: Day 0 to 2 weeks post end of treatment

Number of patients experiencing adverse events

Time Frame: Day 0 to Week 16

Secondary Outcomes

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