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

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ClinicalTrials.gov Identifier: NCT02596074
Recruitment Status : Completed
First Posted : November 4, 2015
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
Maruho Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Usual Type Vulval Intraepithelial Neoplasia (uVIN) Drug: Omiganan (CLS001) topical gel Drug: Vehicle topical gel Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2015
Actual Primary Completion Date : March 7, 2017
Actual Study Completion Date : July 4, 2017

Arm Intervention/treatment
Experimental: Omiganan (CLS001)
CLS001 topical gel, 2.5%
Drug: Omiganan (CLS001) topical gel
Placebo Comparator: Vehicle
Vehicle topical gel
Drug: Vehicle topical gel



Primary Outcome Measures :
  1. Pharmacodynamics (HPV Viral Load Assessment) [ Time Frame: 24 Weeks ]
    Assessment of target lesions by quantitative PCR including HPV genotyping in swabs and biopsies

  2. Pharmacodynamics (Local Immunity Status) [ Time Frame: 24 Weeks ]
    Histological changes in immune cells in the mucosa/submucosa

  3. Clinical Assessment (Lesions by RECIST) [ Time Frame: 24 Weeks ]
    Efficacy assessment of lesions by RECIST

  4. Clinical Assessment (Percent clearance of Lesions) [ Time Frame: 24 Weeks ]
    Efficacy assessment of percent clearance of lesions

  5. Clinical Assessment (Sum of the longest diameter (SLD)) [ Time Frame: 24 Weeks ]
    Efficacy assessment of the sum of the longest diameter (SLD))

  6. Clinical Assessment (Histology) [ Time Frame: 24 Weeks ]
    Efficacy assessment of the histology (regression of uVIN to no dysplasia)


Secondary Outcome Measures :
  1. Safety and Tolerability (Adverse Events) [ Time Frame: 48 Weeks ]
    Adverse Events will be collected throughout the study

  2. Safety and Tolerability (Laboratory Safety Testing) [ Time Frame: 48 Weeks ]
    Laboratory Samples will be collected throughout the study

  3. Safety and Tolerability (12-Lead ECGs) [ Time Frame: 48 Weeks ]
    12-Lead ECGs will be performed throughout the study

  4. Safety and Tolerability (Vital Signs) [ Time Frame: 48 Weeks ]
    Vital Signs will be collected throughout the study

  5. Pharmacokinetics (Area Under the Curve) [ Time Frame: 12 Weeks ]
    AUC will be computed

  6. Pharmacokinetics (Maximum Plasma Concentration) [ Time Frame: 12 Weeks ]
    Cmax will be determined

  7. Pharmacokinetics (Tmax) [ Time Frame: 12 Weeks ]
    Tmax will be determined



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596074


Locations
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Netherlands
LUMC/Centre for Human Drug Research
Leiden, Netherlands
Sponsors and Collaborators
Maruho Co., Ltd.
Investigators
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Principal Investigator: J. (Koos) Burggraaf, MD, PhD Centre for Human Drug Research

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Responsible Party: Maruho Co., Ltd.
ClinicalTrials.gov Identifier: NCT02596074     History of Changes
Other Study ID Numbers: CLS001-CO-PR-010
2015-002724-16 ( EudraCT Number )
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Carcinoma in Situ
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimicrobial Cationic Peptides
Anti-Infective Agents