NCT02596074

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2017

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

1.3 years

First QC Date

October 29, 2015

Last Update Submit

August 1, 2017

Conditions

Usual Type Vulval Intraepithelial Neoplasia (uVIN)

Outcome Measures

Primary Outcomes (6)

  • Pharmacodynamics (HPV Viral Load Assessment)

    Assessment of target lesions by quantitative PCR including HPV genotyping in swabs and biopsies

    24 Weeks

  • Pharmacodynamics (Local Immunity Status)

    Histological changes in immune cells in the mucosa/submucosa

    24 Weeks

  • Clinical Assessment (Lesions by RECIST)

    Efficacy assessment of lesions by RECIST

    24 Weeks

  • Clinical Assessment (Percent clearance of Lesions)

    Efficacy assessment of percent clearance of lesions

    24 Weeks

  • Clinical Assessment (Sum of the longest diameter (SLD))

    Efficacy assessment of the sum of the longest diameter (SLD))

    24 Weeks

  • Clinical Assessment (Histology)

    Efficacy assessment of the histology (regression of uVIN to no dysplasia)

    24 Weeks

Secondary Outcomes (7)

  • Safety and Tolerability (Adverse Events)

    48 Weeks

  • Safety and Tolerability (Laboratory Safety Testing)

    48 Weeks

  • Safety and Tolerability (12-Lead ECGs)

    48 Weeks

  • Safety and Tolerability (Vital Signs)

    48 Weeks

  • Pharmacokinetics (Area Under the Curve)

    12 Weeks

  • +2 more secondary outcomes

Study Arms (2)

Omiganan (CLS001)

EXPERIMENTAL

CLS001 topical gel, 2.5%

Drug: Omiganan (CLS001) topical gel

Vehicle

PLACEBO COMPARATOR

Vehicle topical gel

Drug: Vehicle topical gel

Interventions

Omiganan (CLS001) topical gelDRUG
Omiganan (CLS001)
Vehicle topical gelDRUG
Vehicle

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women ≥ 18 years
  • Biopsy proven uVIN, biopsies to have been taken within the last three months
  • Written informed consent to participate in the trial
  • 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.

You may not qualify if:

  • 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.
  • 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.
  • Indication of a current active infectious disease of the vulva, other than HPV
  • Pregnant, breast feeding or trying to conceive
  • Active treatment for uVIN (i.e. surgical excision, lasertherapy, imiquimod, photodynamic therapy) within the previous month
  • Patients receiving immunosuppressive therapy
  • HIV positive or transplant patients
  • Any condition that in the opinion of the investigator could interfere with the conduct of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LUMC/Centre for Human Drug Research

Leiden, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 31755993DERIVED

MeSH Terms

Interventions

OmigananGels

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • J. (Koos) Burggraaf, MD, PhD

    Centre for Human Drug Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2015

First Posted

November 4, 2015

Study Start

November 1, 2015

Primary Completion

March 7, 2017

Study Completion

July 4, 2017

Last Updated

August 3, 2017

Record last verified: 2017-08

Locations

NL(1)