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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02724254
• Date of registration: 21/03/2016
• Prospective Registration: No
• Primary sponsor: Vaxart
• Public title: 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
• Scientific title: 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
• Date of first enrolment: January 2016
• Target sample size: 218
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02724254
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Argentina, Chile, Ecuador, Serbia

Contacts

• Name: Anna Novotney-Barry
• Affiliation: Aviragen Therapeutics, Inc.

Key inclusion & exclusion criteria

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.

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Condyloma

Intervention(s)

Drug: AP611074 5% gel

Drug: AP611074 matching placebo

Primary Outcome(s)

Number of patients experiencing adverse events [Time Frame: Day 0 to Week 16]

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]

Secondary Outcome(s)

Time to complete clearance [Time Frame: Day 0 to week 16]

Proportion of subjects with a complete clearance rate (100%) for baseline genital wart lesions [Time Frame: Day 0 to week 16]

Proportion of subjects with a complete clearance rate (100%) for all genital wart lesions [Time Frame: Day 0 to week 16]

Reduction in the total condyloma area for lesions [Time Frame: Day 0 to week 16]

Secondary ID(s)

AP611074.CT4

Source(s) of Monetary Support

Please refer to primary and secondary sponsors