Primary Objectives* To explore the pharmacodynamic effects of topically applied omiganan in patients with external genital warts* To explore clinical efficacy of omiganan compared to placebo in patients with external genital warts.Secondary…
ID
Source
Brief title
Condition
- Other condition
- Female reproductive tract infections and inflammations
Synonym
Health condition
voortplantingsstelsel- en borstaandoeningen; voortplantingsstelselinfecties en -ontstekingen, mannelijk
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Exploratory clinical efficacy endpoints / Pharmacodynamic endpoints
* Count of all lesions visible
* Percent clearance of treated lesions
o Proportion of all baseline lesions cleared
o Proportion of all (baseline and new) lesions cleared
o Proportion of subjects with cleared treated lesions (90% / 75% / 50%)
* Absolute reduction in target wart size
o Diameter (mm)
o Height (mm)
o Volume (mm3)
* Target wart size reduction (percentage)
* Change in patient-reported outcomes (QoL and patient-reported clearance)
* Histology / Local immunity status
* Wart size of all warts of interest (target and biopsy warts) by standardized
clinical 2D and 3D photography
* HPV viral load assessment of primary wart by quantitative PCR including HPV
genotyping
in swabs
* Change from baseline in the HPV viral load (nominal, natural log transformed,
and natural
log of viral load per DNA copies) as determined by qPCR
* Mean HPV viral load (nominal, natural log transformed, and natural log of
viral load per DNA
copies) at treatment weeks and overall study
* Biomarkers in biopsies (IFN-*, IFN-beta, IL-1beta, IL-8)
Tolerability / safety endpoints
* Compliance with dosing instructions (patient completed e-diary)
* Adverse events (AE)
* Laboratory safety testing
o Chemistry
o Hematology
o Urinalysis
* Treatment-emergent (serious) adverse events ((S)AEs).
* Vital signs
o Pulse Rate (bpm)
o Systolic blood pressure (mmHg)
o Diastolic blood pressure (mmHg)
o Temperature
* Electrocardiogram (ECG)
o Heart Rate (HR) (bpm), PR, QRS, QT, QTcB, QTcF
Secondary outcome
Compliance with dosing instructions (patient completed e-diary)
Adverse events (AE)
Laboratory safety testing
o Chemistry
o Hematology
o Urinalysis
Treatment-emergent (serious) adverse events ((S)AEs).
Vital signs
o Pulse Rate (bpm)
o Systolic blood pressure (mmHg)
o Diastolic blood pressure (mmHg)
o Temperature
Electrocardiogram (ECG)
o Heart Rate (HR) (bpm), PR, QRS, QT, QTcB, QTcF
Background summary
Genital warts is a human papillomavirus (HPV)-induced non-malignant disorder
affecting the genital epithelia. HPV is the most frequent sexually transmitted
viral infection. The most common HPV types causing genital warts are HPV 6 and
HPV 11, which are low risk HPV genotypes.
The annual incidence of genital warts in male and female is approximately
194,5 per 100.000 in a review of the scientific literature [1]. Clinical
symptoms include pruritus, burning and often patients have psychosocial
problems. Genital warts are highly infectious, approximately 65% of individuals
with an infected partner develop genital warts. Standard treatments are topical
application of podophyllotoxin (Condyline), imiquimod (Aldara) or
sinecatechines (Veregen) or surgical treatments like cryotherapy, local
excision or laser treatment. With these drug treatments local irritation which
can be treatment limiting is common, surgical interventions also have the
associated discomfort. Even after treatment, recurrence rates of genital warts
are reported to be as high as 30-50%. Recently, prophylactic vaccines were
proven to offer immunity against certain HPV types and are included in the
Dutch national vaccination program. However, currently no HPV vaccine is
registered as therapeutic vaccine. Also the bivalent vaccine (Cervarix), used
in the national vaccination program, only protects against the high risk
oncogenic HPV types 16 and 18, which are not associated with genital warts.
Therefore, there remains an unmet medical need for a well-tolerated topical
treatment that patients can safely apply at home and a treatment which is
effective in treating external genital warts.
Study objective
Primary Objectives
* To explore the pharmacodynamic effects of topically applied omiganan in
patients with external genital warts
* To explore clinical efficacy of omiganan compared to placebo in patients with
external genital warts.
Secondary Objective
* To assess safety and tolerability of topically applied omiganan in patients
with external genital warts.
Study design
This is a phase 2, randomized, double-blind, vehicle-controlled parallel-group
study. Eligible patients will be randomized in two treatment arms: 2.5%
omiganan gel or vehicle, i.e. placebo, gel. The gel will be applied topically
once daily for 12 weeks, with a ratio of 2:1 (active:placebo). Per subject two
or more external genital warts will be treated.
Intervention
CLS001 gel 2.5% omiganan pentahydrochlorid x 12 weeks x QD
Study burden and risks
The risks associated with the topical administration of CLS001 to humans has
been identified in over 2500 subjects in total in
fourteen clinical trials completed with topical applications of omiganan in
formulations ranging from 0.5% to 3% in an aqueous gel
and from 1% to 5% in an alcoholic solution for the indications of various
indications including treatment of the inflammatory lesions of
rosacea, treatment of acne and treatment of S. aureus in the nasal carriage.
Omiganan when applied topically to intact or abraded
skin, intranasally or at peripheral and central venous catheter sites appears
to be safe and well tolerated. In addition, omiganan was
not detected in the plasma of subjects after topical application to intact or
abraded skin, to the nasal mucosa or at peripheral catheter
sites. The risk of topical application to a very restricted lesional area can
be considered minimal. Potential beneficial effects on external genital warts
are to be explored in this study.
Therefore, providing the protocol is adhered to, careful observation and
medical management will minimize any associated risk in this
study.
1500 Liberty Ridge Drive Suite 3000
Pennsylvania 19087
US
1500 Liberty Ridge Drive Suite 3000
Pennsylvania 19087
US
Listed location countries
Age
Inclusion criteria
For enrollment of subjects the following criteria must be met:
1. Healthy male and female subjects * 18 years of age, with external genital warts. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than genital warts following a detailed medical history and a complete physical examination including vital signs and 12-lead 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.
2. Clinically diagnosed and biopsy confirmed external genital warts. Subject has at least 3 external genital warts.
3. Willing to give written informed consent and willing and able to comply with the study protocol.
Exclusion criteria
Eligible subjects must meet none of the following exclusion criteria at screening:
1. Clinically significant abnormalities, as judged by the Investigator, in laboratory test results
including haematology, blood chemistry panel, virology or urinalysis. 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.
2. Current clinically significant skin conditions in the anogenital area (e.g. atopic dermatitis, lichen sclerosus, lichen planus or psoriasis).
3. Pregnant, breast feeding or trying to conceive.
4. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
5. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.
6. Use of active treatment (i.e. cryotherapy, laser therapy, topical medication and/or surgical treatments) for genital warts within 28 days prior to first study drug administration.
7. Immunosuppressed patients, having an immunodeficiency (primary or secondary, like HIV) or receiving immunosuppressive therapy (i.e. Transplant patients).
8. Males or Females who received a vaccination with Gardasil or Cervarix.
9. Any (medical) condition 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-005553-13-NL |
| CCMO | NL56059.056.16 |