Pharmacodynamics, Safety and Efficacy of Topical Omiganan in Patients With External Genital Warts

Study Overview
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Brief Summary
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The purpose of this study is to assess the pharmacodynamics, safety and efficacy of omiganan in patients with external genital warts.

Official Title
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A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Parallel-Group Study to Explore the Pharmacodynamics, Safety and Efficacy of Topical Omiganan in Patients With External Genital Warts

Conditions
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Condylomata Acuminata (External)

Intervention / Treatment
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* Drug: Omiganan (CLS001) topical gel
* Drug: Vehicle topical gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female subjects ≥ 18 years of age, with external genital warts. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than genital warts following a detailed medical history and a complete physical examination including vital signs and 12-lead ECG. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects. Clinically diagnosed and biopsy confirmed external genital warts. Subject has at least 3 external genital warts. Willing to give written informed consent and willing and able to comply with the study protocol. Exclusion Criteria: Eligible subjects must meet none of the following exclusion criteria at screening: Clinically significant abnormalities, as judged by the Investigator, in laboratory test results including haematology, blood chemistry panel, virology or urinalysis. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects. Current clinically significant skin conditions in the anogenital area (e.g. atopic dermatitis, lichen sclerosus, lichen planus or psoriasis). Pregnant, breast feeding or trying to conceive. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening. Use of active treatment (i.e. cryotherapy, laser therapy, topical medication and/or surgical treatments) for genital warts within 28 days prior to first study drug administration. Immunosuppressed patients, having an immunodeficiency (primary or secondary, like HIV) or receiving immunosuppressive therapy (i.e. Transplant patients). Males or Females who received a vaccination with Gardasil or Cervarix. Any (medical) condition that would, in the opinion of the Investigator, potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omiganan (CLS001)<br>CLS001 Topical Gel, 2.5% | Drug: Omiganan (CLS001) topical gel<br> <br> |
| Placebo Comparator: Vehicle<br>Vehicle Topical Gel | Drug: Vehicle topical gel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Assessment (Visible Lesions) | Count of all visible lesions | 24 Weeks | 
| Clinical Assessment (Percent clearance of treated lesions) |  | 24 Weeks | 
| Clinical Assessment (Reduction of wart size) | Includes 2D and 3D photography | 24 Weeks | 
| Clinical Assessment (PRO) | Change in Patient-reported outcomes | 24 Weeks | 
| Pharmacodynamics (Local Immunity Status) | Histological changes | 24 Weeks | 
| Pharmacodynamics (HPV Viral Load Assessment) | Quantitative PCR including HPV genotyping in swabs, qPCR to assess change from baseline, mean HPV viral load at treatment weeks and overall | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability (e-diary) | Compliance with dosing instructions (patient completed e-diary) | 24 Weeks | 
| Safety (AE) | Adverse Events will be collected throughout the study | 24 Weeks | 
| Safety (Laboratory Safety Testing) | Lab samples will be collected throughout the study | 24 Weeks | 
| Safety (Treatment-emergent AE and SAE) | Treatment-emergent AE and SAE will be collected throughout the study | 24 Weeks | 
| Safety (Vital Signs) | Vital Signs will be collected throughout the study | 24 Weeks | 
| Safety (ECG) | ECGs will be collected at before beginning and end of study | Screening and End of Study |