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

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

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

Study Overview

• Status: Completed
• Conditions: Condylomata Acuminata (External)
• Intervention / Treatment: Drug: Omiganan (CLS001) topical gel; Drug: Vehicle topical gel

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

Contacts and Locations

Study Locations

• Netherlands
  • Leiden, Netherlands
    • LUMC/Centre for Human Drug Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 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
Placebo Comparator: Vehicle; Vehicle Topical Gel	Drug: Vehicle topical gel
Experimental: Omiganan (CLS001); CLS001 Topical Gel, 2.5%	Drug: Omiganan (CLS001) topical gel

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maruho Co., Ltd.
• Collaborators: Leiden University Medical Center

Publications and helpful links

General Publications

• Rijsbergen M, Rijneveld R, Todd M, Feiss GL, Kouwenhoven STP, Quint KD, van Alewijk DCJG, de Koning MNC, Klaassen ES, Burggraaf J, Rissmann R, van Poelgeest MIE. Results of phase 2 trials exploring the safety and efficacy of omiganan in patients with human papillomavirus-induced genital lesions. Br J Clin Pharmacol. 2020 Nov;86(11):2133-2143. doi: 10.1111/bcp.14181. Epub 2020 Sep 28.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): March 21, 2017
• Study Completion (Actual): March 21, 2017

Study Registration Dates

• First Submitted: July 27, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (Estimate): July 29, 2016

Study Record Updates

• Last Update Posted (Actual): March 31, 2017
• Last Update Submitted That Met QC Criteria: March 29, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Skin Diseases, Infectious; Warts; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Condylomata Acuminata
• Other Study ID Numbers: CLS001-CO-PR-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO