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

NCT02849262 | Completed Phase 2

• 1 other identifier: CLS001-CO-PR-011
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Condylomata Acuminata (External)

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Safety and Tolerability (e-diary)

  24 Weeks

• Safety (AE)

  24 Weeks

• Safety (Laboratory Safety Testing)

  24 Weeks

• Safety (Treatment-emergent AE and SAE)

  24 Weeks

• Safety (Vital Signs)

  24 Weeks

Study Arms (2)

Omiganan (CLS001)

EXPERIMENTAL

CLS001 Topical Gel, 2.5%

Drug: Omiganan (CLS001) topical gel

Vehicle

PLACEBO COMPARATOR

Vehicle Topical Gel

Drug: Vehicle topical gel

Interventions

Omiganan (CLS001) topical gel DRUG

Omiganan (CLS001)

Vehicle topical gel DRUG

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maruho Co., Ltd.: lead
• Leiden University Medical Center: collaborator

Study Sites (1)

LUMC/Centre for Human Drug Research

Leiden, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 31755993 DERIVED

MeSH Terms

Conditions

Condylomata Acuminata

Interventions

Omiganan; Gels

Condition Hierarchy (Ancestors)

Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: July 29, 2016
• Study Start: July 1, 2016
• Primary Completion: March 21, 2017
• Study Completion: March 21, 2017
• Last Updated: March 31, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)