Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts

A Double-blind, Placebo Controlled, Randomized, Phase IIa Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of Repeated Topical Applications Over 42 Days of AP611074 5% Gel in Condyloma Patients

The purpose of this study is to determine the safety, tolerability and efficacy of the topical application of AP611074 5% gel during 6 weeks on ano-genital warts caused by human papillomavirus (HPV).

Study Overview

• Status: Completed
• Conditions: Human Papillomavirus Infection; Condylomata Acuminata; Anogenital Warts
• Intervention / Treatment: Drug: AP611074; Drug: Placebo

Detailed Description

Genital warts (GW; also called condylomas or condylomata acuminata) are lesions caused by infection of Human papillomavirus (HPV)(specifically HPV-6 or HPV-11 types, found in > 95% of lesions). GW are sexually transmitted and affect about 1% of the sexually active population. GW represent a distressful condition for social and sexual life, especially in the cases of external condylomas. No HPV-specific antiviral treatment exists to date, and all existing therapies (either surgical or drug) have limited efficacy, with a significant level of GW recurrences and are associated with local skin reactions. AP611074 is a synthetic new chemical entity that is a potent and selective inhibitor of the interaction between two viral proteins from HPV6 and HPV11, an interaction that is a necessary step for HPV DNA replication and thus viral production. AP611074 is the "first in class" specific HPV antiviral described to treat condyloma caused by HPV infection.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1122AAL
    • IADT - Instituto Argentino de Diagnostico y Tratamiento S.A.
  • Buenos Aires, Argentina, C1181ACH
    • Hospotal Italinao de Buenos Aires - Dept of Dermatology and Gynecology
• France
  • Creteil, France, 94010
    • Hopital Henri Mondor-Dept of Dermatology
  • Paris, France, 75014
    • SGS Aster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Main Inclusion Criteria:

• Male or female patient aged between 18 and 55 years.
• External condylomas, 1-15 lesions, non-confluent and individually isolated.
• Lesions must not be internal (ie, they must not penetrate the urethral meatus, vagina or anal canal); their visualization must be complete by patients and investigators without major facilitation maneuvers and easily documented by digital pictures.
• Lesions should have a total surface smaller than 5 cm2, and an individual surface smaller than 1 cm2; lesions should be easily measured using a "French Catheter Scale".
• Lesions to be treated should have appeared between 1-6 months before screening and patients should not have received any previous condyloma treatment since their appearance.
• For patients having previous episodes of condyloma lesions, they shouldn't have received any condyloma treatment for at least 12 months before screening.

Main Exclusion Criteria:

• Patients with any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease that, in the Investigator's judgment, prevents the patients from participating to the study.
• Patients with VIN or PIN (intraepithelial neoplasia of vulva or penis; ie, Bowenoid papulosis), or genital disease (ie, lichen sclerosus, lichen planus, lichen simplex chronicus, dermatitis, psoriasis, bullous diseases, systemic diseases with genital manifestations) requiring treatment.
• Patients with fibroepithelial polyps or scaly non-viral papillomas, seborrheic keratosis, follicular papules, syringoma, or circumscribed lymphangiomas.
• Patients whose skin condition or coloration would interfere with the observation and the follow-up of the lesions during the study.
• Patients for whom a proper follow-up of the lesions during the study will not be possible, because of hair growth in the treatment area.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AP611074 5% gel; Twice daily application of 100 mg dose of AP611074 5% gel for 41 days followed by a single morning application on Day 42	Drug: AP611074; Other Names: HPV antiviral; Anticondyloma drug
Placebo Comparator: Placebo gel; Twice daily application of 100 mg dose of placebo gel for 41 days followed by a single morning application on Day 42	Drug: Placebo; Placebo gel manufactured to appear identical to AP611074 5% gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complete or partial regression of anogenital warts, based on the total lesion surface before and after treatment	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and local tolerability	Descriptive statistics will be calculated by comparing the number of subjects between Day 1 and Day 42 in each treatment group (active or placebo) presenting AEs, or changes in physical examination, vital signs (blood pressure and pulse rate), 12-lead ECG, clinical laboratory parameters (biochemistry, hematology, urinalysis), and local tolerability (erythema, scaling, stinging, oedema)	Up to 8 weeks
Pharmacokinetic evaluation	Plasma concentrations of AP611074 will be measured from blood samples once weekly up to 8 weeks in all patients. Data will be summarized with descriptive statistics by nominal sampling time.	Up to 8 weeks

Collaborators and Investigators

• Sponsor: Anaconda Pharma
• Investigators: Principal Investigator: Olivier CHOSIDOW, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2012
• Primary Completion (Actual): May 6, 2013
• Study Completion (Actual): May 6, 2013

Study Registration Dates

• First Submitted: January 12, 2012
• First Submitted That Met QC Criteria: February 13, 2012
• First Posted (Estimate): February 14, 2012

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Human papillomavirus; HPV; Antiviral; Genital warts; Anogenital warts
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Tumor Virus Infections; Warts; Papillomavirus Infections; Anti-Infective Agents; Antiviral Agents
• Other Study ID Numbers: AP611074.CT3; 2011-003760-80 (EudraCT Number)