Usual Type Vulval Intraepithelial Neoplasia (uVIN)Phase 2NCT02596074
Pharmacodynamics, Safety/Tolerability and Efficacy of Topical Omiganan in Patients With uVIN
A Phase 2 study testing Omiganan (CLS001) topical gel in people with Usual Type Vulval Intraepithelial Neoplasia (uVIN), run by Maruho Co., Ltd. at 1 site in Netherlands.
Trial summary
To assess the pharmacodynamics, safety/tolerability and efficacy of topical Omiganan (CLS001) in patients with usual type vulvar intraepithelial neoplasia (uVIN). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Usual Type Vulval Intraepithelial Neoplasia (uVIN)
- What is being tested?
- Omiganan (CLS001) topical gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2015to 4 Jul 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
To assess the pharmacodynamics, safety/tolerability and efficacy of topical Omiganan (CLS001) in patients with usual type vulvar intraepithelial neoplasia (uVIN).
- Being tested
- Omiganan (CLS001) topical gel, Vehicle topical gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omiganan (CLS001) topical gelDrug
Vehicle topical gelDrug
| Study group | Role | What they receive |
|---|---|---|
| Omiganan (CLS001) | Experimental | CLS001 topical gel, 2.5% Receives: Drug: Omiganan (CLS001) topical gel |
| Vehicle | Placebo comparator | Vehicle topical gel Receives: Drug: Vehicle topical gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics (HPV Viral Load Assessment)
Assessment of target lesions by quantitative PCR including HPV genotyping in swabs and biopsies
Measured: 24 Weeks
Pharmacodynamics (Local Immunity Status)
Histological changes in immune cells in the mucosa/submucosa
Measured: 24 Weeks
Clinical Assessment (Lesions by RECIST)
Efficacy assessment of lesions by RECIST
Measured: 24 Weeks
Clinical Assessment (Percent clearance of Lesions)
Efficacy assessment of percent clearance of lesions
Measured: 24 Weeks
Clinical Assessment (Sum of the longest diameter (SLD))
Efficacy assessment of the sum of the longest diameter (SLD))
Measured: 24 Weeks
Clinical Assessment (Histology)
Efficacy assessment of the histology (regression of uVIN to no dysplasia)
Measured: 24 Weeks
Secondary outcomes (7)
Safety and Tolerability (Adverse Events)
Adverse Events will be collected throughout the study
Measured: 48 Weeks
Safety and Tolerability (Laboratory Safety Testing)
Laboratory Samples will be collected throughout the study
Measured: 48 Weeks
Safety and Tolerability (12-Lead ECGs)
12-Lead ECGs will be performed throughout the study
Measured: 48 Weeks
Safety and Tolerability (Vital Signs)
Vital Signs will be collected throughout the study
Measured: 48 Weeks
Pharmacokinetics (Area Under the Curve)
AUC will be computed
Measured: 12 Weeks
Pharmacokinetics (Maximum Plasma Concentration)
Cmax will be determined
Measured: 12 Weeks
Pharmacokinetics (Tmax)
Tmax will be determined
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion7 Mar 2017
- Study completion4 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Usual Type Vulval Intraepithelial Neoplasia (uVIN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maruho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J. (Koos) Burggraaf, MD, PhD, Principal investigator, Centre for Human Drug Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596074
- Sponsor's protocol ID
- CLS001-CO-PR-010
- Other IDs
- 2015-002724-16, 2015
- Status last verified
- Aug 2017
- First submitted
- 29 Oct 2015
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31755993
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02596074
- Acronym / sponsor ID
- CLS001-CO-PR-010
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Maruho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- 7 Mar 2017 (actual)
- Study completion
- 4 Jul 2017 (actual)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the pharmacodynamics, safety/tolerability and efficacy of topical Omiganan (CLS001) in patients with usual type vulvar intraepithelial neoplasia (uVIN).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omiganan (CLS001) | Experimental | Drug: Omiganan (CLS001) topical gelCLS001 topical gel, 2.5% |
| Vehicle | Placebo comparator | Drug: Vehicle topical gelVehicle topical gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omiganan (CLS001) topical gel | Drug | Omiganan (CLS001) |
| Vehicle topical gel | Drug | Vehicle |
Primary outcome
Pharmacodynamics (HPV Viral Load Assessment)
Time frame: 24 Weeks
Assessment of target lesions by quantitative PCR including HPV genotyping in swabs and biopsies
Pharmacodynamics (Local Immunity Status)
Time frame: 24 Weeks
Histological changes in immune cells in the mucosa/submucosa
Clinical Assessment (Lesions by RECIST)
Time frame: 24 Weeks
Efficacy assessment of lesions by RECIST
Clinical Assessment (Percent clearance of Lesions)
Time frame: 24 Weeks
Efficacy assessment of percent clearance of lesions
Clinical Assessment (Sum of the longest diameter (SLD))
Time frame: 24 Weeks
Efficacy assessment of the sum of the longest diameter (SLD))
Clinical Assessment (Histology)
Time frame: 24 Weeks
Efficacy assessment of the histology (regression of uVIN to no dysplasia)
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Derived from this study: PubMed 31755993Rijsbergen 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. (Koos) Burggraaf, MD, PhD principal investigator
Centre for Human Drug Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omiganan (CLS001) topical gel in people with Usual Type Vulval Intraepithelial Neoplasia (uVIN), run by Maruho Co., Ltd. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamics (HPV Viral Load Assessment) (time frame: 24 Weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02596074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.