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

Phase 2

Completed

• Conditions: Condyloma
• Interventions: Drug: AP611074 5% gel; Drug: AP611074 matching placebo

• Registration Number: NCT02724254
• Lead Sponsor: Vaxart

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-21
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-03-31
• Primary Completion: 2018-05
• Status Verified: 2018-07
• Study Completion: 2018-07
• Last Update Submitted: 2018-07-18
• Last Update Posted: 2018-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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 considered internal and are not allowed in the study.
4. Total wart area (diameter x diameter) should not be less than 10mm2 and not more than 800 mm2
5. Individual wart area should not measure more than 50mm2, and the major perpendicular diameter should not measure more than 10mm (1cm).
6. 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.
7. For female patients: either postmenopausal, taking adequate contraceptive method or surgically sterile.

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Exclusion Criteria

1. 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
2. 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.
3. Patients with any clinically significant abnormality following review of screening laboratory tests, vital signs, full physical examination and ECG.
4. Patients with history or presence of drug or alcohol abuse.
5. Patients with positive HBs or HBc antigen or anti HCV antibody, or positive results for HIV 1 or 2 tests.
6. Patients using any dermatological drug therapy in the treatment area during the last month prior the first application of the study drug.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AP611074 5% gel	AP611074 5% gel	100 mg twice daily doses of AP611074 5% gel
Placebo	AP611074 matching placebo	AP611074 matching placebo gel

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Anaconda Invesigational Site; 🇦🇷 Buenos Aires, Argentina

Anaconda Investigational Site; 🇷🇸 Novi Sad, Serbia