Usual Type Vulval Intraepithelial Neoplasia (uVIN)
Conditions
Brief summary
To assess the pharmacodynamics, safety/tolerability and efficacy of topical Omiganan (CLS001) in patients with usual type vulvar intraepithelial neoplasia (uVIN).
Interventions
Sponsors
Maruho Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 (Percent clearance of Lesions) | 24 Weeks | Efficacy assessment of percent clearance of lesions |
| Clinical Assessment (Sum of the longest diameter (SLD)) | 24 Weeks | Efficacy assessment of the sum of the longest diameter (SLD)) |
| Clinical Assessment (Histology) | 24 Weeks | Efficacy assessment of the histology (regression of uVIN to no dysplasia) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability (Adverse Events) | 48 Weeks | Adverse Events will be collected throughout the study |
| Pharmacokinetics (Tmax) | 12 Weeks | Tmax will be determined |
| 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 |
Countries
Netherlands
Outcome results
None listed