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

Study Description

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Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Anogenital Warts; Condylomata Acuminata; Human Papillomavirus Infection	Drug: AP611074; Drug: Placebo	Phase 1; Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	24 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	February 2012
Actual Primary Completion Date :	May 2013

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. Complete or partial regression of anogenital warts, based on the total lesion surface before and after treatment [ Time Frame: 6 weeks ]

Secondary Outcome Measures :

1. Safety and local tolerability [ Time Frame: Up to 8 weeks ]
   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)
2. Pharmacokinetic evaluation [ Time Frame: Up to 8 weeks ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Anaconda Pharma

Investigators

Principal Investigator:	Olivier Chosidow, MD, PhD	Assistance Publique - Hôpitaux de Paris

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Anaconda Pharma
ClinicalTrials.gov Identifier:	NCT01532102 History of Changes
Other Study ID Numbers:	AP611074.CT3; 2011-003760-80 ( EudraCT Number )
First Posted:	February 14, 2012
Last Update Posted:	January 26, 2016
Last Verified:	January 2016

Keywords provided by Aviragen Therapeutics ( Anaconda Pharma ):

Genital warts; Anogenital warts; HPV; Human papillomavirus; Antiviral

Additional relevant MeSH terms:

Warts; Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Skin Diseases, Viral	Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Antiviral Agents; Anti-Infective Agents