Clinical trial NCT02596074: Pharmacodynamics, Safety/Tolerability and Efficacy of Topical Omiganan in Patients With uVIN
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Usual Type Vulval Intraepithelial Neoplasia (uVIN)
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-11-04
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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 ≥ 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

Primary outcomes:
measure: Pharmacodynamics (HPV Viral Load Assessment)
timeFrame: 24 Weeks
measure: Pharmacodynamics (Local Immunity Status)
timeFrame: 24 Weeks
measure: Clinical Assessment (Lesions by RECIST)
timeFrame: 24 Weeks
measure: Clinical Assessment (Percent clearance of Lesions)
timeFrame: 24 Weeks
measure: Clinical Assessment (Sum of the longest diameter (SLD))
timeFrame: 24 Weeks
measure: Clinical Assessment (Histology)
timeFrame: 24 Weeks
Secondary outcomes:
measure: Safety and Tolerability (Adverse Events)
timeFrame: 48 Weeks
measure: Safety and Tolerability (Laboratory Safety Testing)
timeFrame: 48 Weeks
measure: Safety and Tolerability (12-Lead ECGs)
timeFrame: 48 Weeks
measure: Safety and Tolerability (Vital Signs)
timeFrame: 48 Weeks
measure: Pharmacokinetics (Area Under the Curve)
timeFrame: 12 Weeks
measure: Pharmacokinetics (Maximum Plasma Concentration)
timeFrame: 12 Weeks
measure: Pharmacokinetics (Tmax)
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: LUMC/Centre for Human Drug Research
Study officials:
affiliation: Centre for Human Drug Research
name: J. (Koos) Burggraaf, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.