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

Phase 2

Completed

• Conditions: Condylomata Acuminata (External)
• Interventions: Drug: Vehicle topical gel; Drug: Omiganan (CLS001) topical gel

• Registration Number: NCT02849262
• Lead Sponsor: Maruho Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-27
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-07-29
• Status Verified: 2017-03
• Primary Completion: 2017-03-21
• Study Completion: 2017-03-21
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. 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.
2. Clinically diagnosed and biopsy confirmed external genital warts. Subject has at least 3 external genital warts.
3. 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:

1. 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.
2. Current clinically significant skin conditions in the anogenital area (e.g. atopic dermatitis, lichen sclerosus, lichen planus or psoriasis).
3. Pregnant, breast feeding or trying to conceive.
4. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
5. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.
6. 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.
7. Immunosuppressed patients, having an immunodeficiency (primary or secondary, like HIV) or receiving immunosuppressive therapy (i.e. Transplant patients).
8. Males or Females who received a vaccination with Gardasil or Cervarix.
9. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle topical gel	Vehicle Topical Gel
Omiganan (CLS001)	Omiganan (CLS001) topical gel	CLS001 Topical Gel, 2.5%

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

LUMC/Centre for Human Drug Research; 🇳🇱 Leiden, Netherlands