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

NCT02724254 | Completed Phase 2 DMC

• 1 other identifier: AP611074.CT4
• Study Type: interventional
• Target: 218
• Locations: 4 countries
• Sites: 12

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

Conditions

Condyloma

Keywords

Genital warts; HPV types; Sexually Transmitted Disease; Papillomavirus Infections; Viral Disease; Anogenital warts; AGW; HPV6; HPV11; Human papillomavirus infection; HPV; Aviragen Therapeutics, Inc.; Aviragen Therapeutics; Aviragen

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

• Time to complete clearance

  Day 0 to week 16

Study Arms (2)

AP611074 5% gel

EXPERIMENTAL

100 mg twice daily doses of AP611074 5% gel

Drug: AP611074 5% gel

Placebo

PLACEBO COMPARATOR

AP611074 matching placebo gel

Drug: AP611074 matching placebo

Interventions

AP611074 5% gel DRUG

AP611074 5% gel

AP611074 matching placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vaxart: lead

Study Sites (12)

Anaconda Invesigational Site

Buenos Aires, Argentina

Location

Anaconda Investigational Site

Buenos Aires, Argentina

Location

Anaconda Investigational Site

Córdoba, Argentina

Location

Anaconda Investigational Site

Mendoza, Argentina

Location

Anaconda Investigational Site

Sante Fe, Argentina

Location

Anaconda Investigational Site

Concepción, Chile

Location

Anaconda Investigational Site

Santiago, Chile

Location

Anaconda Investigational Site

Cumbayá, Ecuador

Location

Anaconda Investigational Site

Guayaquil, Ecuador

Location

Anaconda Investigational Site

Quito, Ecuador

Location

Anaconda Investigational Site

Belgrade, Serbia

Location

Anaconda Investigational Site

Novi Sad, Serbia

Location

MeSH Terms

Conditions

Condylomata Acuminata; Sexually Transmitted Diseases; Papillomavirus Infections; Virus Diseases

Interventions

Gels

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Communicable Diseases; Infections; DNA Virus Infections; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Anna Novotney-Barry

  Aviragen Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: March 31, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 20, 2018

Record last verified: 2018-07

Locations

AR (5); EC (3); SE (2); CL (2)