Patients with usual type vulvar intraepithelial neoplasia MedDRA version: 18.0 Level: PT Classification code 10054932 Term: Vulvar dysplasia System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Product Name: Omiganan Topical Gel
Product Code: CLS001
Pharmaceutical Form: Gel
INN or Proposed INN: Omiganan Pentahydrochloride
CAS Number: 269-062-93-3
Current Sponsor code: Omiganan Pentahydrochlo
Sponsors
Cutanea Life Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
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 greater than 120mm2 (e.g. 15mm x 8mm or 12mm x 10mm) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 within the previous eight weeks 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 |
|---|---|
| Main Objective: To explore the pharmacodynamic effects on a target lesion of topically applied omiganan in patients with usual type vulvar intraepithelial neoplasia;Secondary Objective: To assess safety and tolerability in patients with usual type vulvar intraepithelial neoplasia To evaluate treatment effect of omiganan compared to placebo in patients with usual type vulvar intraepithelial neoplasia;Primary end point(s): -Efficacy endpoints Change from baseline to each time point of measurement during each treatment period for the following assessments: •Clinical assessment by RECIST •Percent clearance of lesions •Absolute reduction in lesion size (mm2) •Lesion size reduction of more than 50% •Change in patient reported outcomes (pruritus, pain, dyspareunia, QoL) •Sum of the longest diameter (SLD) •Histology (regression of high grade VIN to no dysplasia) •Recurrence at 3 months for the double-blind period -Pharmacodynamic endpoints •HPV viral load assessment of target lesions by quantitative PCR including HPV genotyping in swabs and biopsies •Change from baseline in the HPV viral load (nominal, natural log transformed, and natural log of viral load per DNA copies) as determined by qPCR •Mean HPV viral load (nominal, natural log transformed, and natural log of viral load per DNA copies) at treatment weeks and overall •Local immunity status (changes in immune cells in the mucosa/ submucosa at 4 weeks and 12 weeks) -Pharmacokinetic endpoints Samples for pharmacokinetic determination of plasma Omiganan concentrations will be collected.;Timepoint(s) of evaluation of this end point: - Lesion size and morphology will be analyzed at every study visit: Day 0, 14, 28, 42, 84, 128, 168. - Two biopsies will be taken at day 0, day 42 and day 84 and day 168 if there are still visible lesions. - Swabs are taken on each visit: day 0, 14, 28, 42, 84, 126, 168. - Blood samples are taken on day 0, 84 and 168 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Safety and tolerability endpoints Adverse events (AE) will be collected throughout the study, at every study visit. Laboratory safety tests will be performed at time of screening, End-of-Treatment and at End-of-Study. Vital signs will be measured throughout the study at every visit day. 12-Lead ECGs will be performed at screening, pre-dose day 0, at EOT and EOS visits. Safety / tolerability endpoints include: •Treatment-emergent (serious) adverse events ((S)AEs). •Patient reported treatment satisfaction •Concomitant medication •Clinical laboratory tests: Haematology, Chemistry, Urinalysis •Vital signs: Pulse Rate (bpm), Systolic blood pressure (mmHg), Diastolic blood pressure (mmHg) •Electrocardiogram (ECG): Heart Rate (HR) (bpm), PR, QRS, QT, QTcB;Timepoint(s) of evaluation of this end point: - Adverse events will be collected at every visit: day 0, 14, 28, 42, 56, 70, 84, 126, 168. - Blood samples are taken on day 0, 84 and 168 - ECGs are performed at day 0, 84 and 168 | — |
Countries
Netherlands
Contacts
Public ContactJ. Burggraaf
Centre for Human Drug Research
Outcome results
None listed