Pharmacodynamics, Safety/Tolerability and Efficacy of Topical Omiganan in Patients With uVIN

A Phase 2, Randomized, Double-Blind, Parallel-Group Study to Assess the Pharmacodynamics, Safety/Tolerability and Efficacy of Topical Omiganan in Patients With Usual Type Vulvar Intraepithelial Neoplasia

To assess the pharmacodynamics, safety/tolerability and efficacy of topical Omiganan (CLS001) in patients with usual type vulvar intraepithelial neoplasia (uVIN).

Study Overview

• Status: Completed
• Conditions: Usual Type Vulval Intraepithelial Neoplasia (uVIN)
• Intervention / Treatment: Drug: Omiganan (CLS001) topical gel; Drug: Vehicle topical gel

• Study Type: Interventional
• Enrollment (Actual): 12
• 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: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women ≥ 18 years
2. Biopsy proven uVIN, biopsies to have been taken within the last three months
3. Written informed consent to participate in the trial

4. At least one lesion that can be accurately measured (using RECIST criteria)

   • in at least one dimension with longest diameter ≥ 20mm
   • OR in two perpendicular dimensions that when multiplied together give a surface area of ≥ 120mm2 (e.g. 15mm x 8mm or 12mm x 10mm)
   • This is to ensure that 4x4mm biopsies can be performed on this lesion.

Exclusion Criteria:

1. Has any concomitant disease or significant medical conditions 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.
2. Clinically significant abnormalities, as judged by the Investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis) or 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.
3. Indication of a current active infectious disease of the vulva, other than HPV
4. Pregnant, breast feeding or trying to conceive
5. Active treatment for uVIN (i.e. surgical excision, lasertherapy, imiquimod, photodynamic therapy) within the previous month
6. Patients receiving immunosuppressive therapy
7. HIV positive or transplant patients
8. Any condition that in the opinion of the investigator could interfere with the conduct of the study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamics (HPV Viral Load Assessment)	Assessment of target lesions by quantitative PCR including HPV genotyping in swabs and biopsies	24 Weeks
Pharmacodynamics (Local Immunity Status)	Histological changes in immune cells in the mucosa/submucosa	24 Weeks
Clinical Assessment (Lesions by RECIST)	Efficacy assessment of lesions by RECIST	24 Weeks
Clinical Assessment (Percent clearance of Lesions)	Efficacy assessment of percent clearance of lesions	24 Weeks
Clinical Assessment (Sum of the longest diameter (SLD))	Efficacy assessment of the sum of the longest diameter (SLD))	24 Weeks
Clinical Assessment (Histology)	Efficacy assessment of the histology (regression of uVIN to no dysplasia)	24 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability (Adverse Events)	Adverse Events will be collected throughout the study	48 Weeks
Safety and Tolerability (Laboratory Safety Testing)	Laboratory Samples will be collected throughout the study	48 Weeks
Safety and Tolerability (12-Lead ECGs)	12-Lead ECGs will be performed throughout the study	48 Weeks
Safety and Tolerability (Vital Signs)	Vital Signs will be collected throughout the study	48 Weeks
Pharmacokinetics (Area Under the Curve)	AUC will be computed	12 Weeks
Pharmacokinetics (Maximum Plasma Concentration)	Cmax will be determined	12 Weeks
Pharmacokinetics (Tmax)	Tmax will be determined	12 Weeks

Collaborators and Investigators

• Sponsor: Maruho Co., Ltd.
• Investigators: Principal Investigator: J. (Koos) Burggraaf, MD, PhD, Centre for Human Drug Research

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: November 1, 2015
• Primary Completion (Actual): March 7, 2017
• Study Completion (Actual): July 4, 2017

Study Registration Dates

• First Submitted: October 29, 2015
• First Submitted That Met QC Criteria: November 3, 2015
• First Posted (Estimate): November 4, 2015

Study Record Updates

• Last Update Posted (Actual): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms; Carcinoma in Situ
• Other Study ID Numbers: CLS001-CO-PR-010; 2015-002724-16 (EudraCT Number)