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

Maruho

Status and phase: Completed; Phase 2

Conditions: Usual Type Vulval Intraepithelial Neoplasia (uVIN)

Treatments: Drug: Omiganan (CLS001) topical gel; Drug: Vehicle topical gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02596074

2015-002724-16 (EudraCT Number)

CLS001-CO-PR-010

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

Omiganan (CLS001)

Experimental group

Description:

CLS001 topical gel, 2.5%

Treatment:

Drug: Omiganan (CLS001) topical gel

Vehicle

Placebo Comparator group

Description:

Vehicle topical gel

Treatment:

Drug: Vehicle topical gel