Overview

This trial is active, not recruiting.

Condition usual type vulval intraepithelial neoplasia (uvin)
Treatments omiganan (cls001) topical gel, vehicle topical gel
Phase phase 2
Sponsor Cutanea Life Sciences, Inc.
Start date November 2015
End date March 2017
Trial size 12 participants
Trial identifier NCT02596074, 2015-002724-16, CLS001-CO-PR-010

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
CLS001 topical gel, 2.5%
omiganan (cls001) topical gel
(Placebo Comparator)
Vehicle topical gel
vehicle topical gel

Primary Outcomes

Measure
Pharmacodynamics (HPV Viral Load Assessment)
time frame: 24 Weeks
Pharmacodynamics (Local Immunity Status)
time frame: 24 Weeks
Clinical Assessment (Lesions by RECIST)
time frame: 24 Weeks
Clinical Assessment (Percent clearance of Lesions)
time frame: 24 Weeks
Clinical Assessment (Sum of the longest diameter (SLD))
time frame: 24 Weeks
Clinical Assessment (Histology)
time frame: 24 Weeks

Secondary Outcomes

Measure
Safety and Tolerability (Adverse Events)
time frame: 48 Weeks
Safety and Tolerability (Laboratory Safety Testing)
time frame: 48 Weeks
Safety and Tolerability (12-Lead ECGs)
time frame: 48 Weeks
Safety and Tolerability (Vital Signs)
time frame: 48 Weeks
Pharmacokinetics (Area Under the Curve)
time frame: 12 Weeks
Pharmacokinetics (Maximum Plasma Concentration)
time frame: 12 Weeks
Pharmacokinetics (Tmax)
time frame: 12 Weeks

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

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
Principal investigator J. (Koos) Burggraaf, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Cutanea Life Sciences, Inc..