Pharmacodynamics, Safety/Tolerability and Efficacy of Topical Omiganan in Patients With uVIN
- Conditions
- Usual Type Vulval Intraepithelial Neoplasia (uVIN)
- Interventions
- Drug: Vehicle topical gel
- Registration Number
- NCT02596074
- Lead Sponsor
- Maruho Co., Ltd.
- Brief Summary
To assess the pharmacodynamics, safety/tolerability and efficacy of topical Omiganan (CLS001) in patients with usual type vulvar intraepithelial neoplasia (uVIN).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 12
-
Women ≥ 18 years
-
Biopsy proven uVIN, biopsies to have been taken within the last three months
-
Written informed consent to participate in the trial
-
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.
- 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.
- 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.
- Indication of a current active infectious disease of the vulva, other than HPV
- Pregnant, breast feeding or trying to conceive
- Active treatment for uVIN (i.e. surgical excision, lasertherapy, imiquimod, photodynamic therapy) within the previous month
- Patients receiving immunosuppressive therapy
- HIV positive or transplant patients
- Any condition that in the opinion of the investigator could interfere with the conduct of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Omiganan (CLS001) Omiganan (CLS001) topical gel CLS001 topical gel, 2.5% Vehicle Vehicle topical gel Vehicle topical gel
- Primary Outcome Measures
Name Time Method Pharmacodynamics (HPV Viral Load Assessment) 24 Weeks Assessment of target lesions by quantitative PCR including HPV genotyping in swabs and biopsies
Pharmacodynamics (Local Immunity Status) 24 Weeks Histological changes in immune cells in the mucosa/submucosa
Clinical Assessment (Lesions by RECIST) 24 Weeks Efficacy assessment of lesions by RECIST
Clinical Assessment (Sum of the longest diameter (SLD)) 24 Weeks Efficacy assessment of the sum of the longest diameter (SLD))
Clinical Assessment (Percent clearance of Lesions) 24 Weeks Efficacy assessment of percent clearance of lesions
Clinical Assessment (Histology) 24 Weeks Efficacy assessment of the histology (regression of uVIN to no dysplasia)
- Secondary Outcome Measures
Name Time Method Safety and Tolerability (Adverse Events) 48 Weeks Adverse Events will be collected throughout the study
Safety and Tolerability (Laboratory Safety Testing) 48 Weeks Laboratory Samples will be collected throughout the study
Safety and Tolerability (12-Lead ECGs) 48 Weeks 12-Lead ECGs will be performed throughout the study
Safety and Tolerability (Vital Signs) 48 Weeks Vital Signs will be collected throughout the study
Pharmacokinetics (Area Under the Curve) 12 Weeks AUC will be computed
Pharmacokinetics (Maximum Plasma Concentration) 12 Weeks Cmax will be determined
Pharmacokinetics (Tmax) 12 Weeks Tmax will be determined
Trial Locations
- Locations (1)
LUMC/Centre for Human Drug Research
🇳🇱Leiden, Netherlands