CondylomaPhase 2NCT02724254
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Topical Applications of AP611074 5% Gel for up to 16 Weeks in Condyloma Patients
A Phase 2 study testing AP611074 5% gel in people with Condyloma, run by Vaxart at 12 sites in 4 countries.
Trial summary
This is a double-blind placebo controlled, randomized, phase 2 study to assess the safety, tolerability, pharmacokinetics and efficacy of twice daily topical applications of AP611074 5% Gel for up to 16 weeks in condyloma patients Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Condyloma
- What is being tested?
- AP611074 5% gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Jan 2016to Jul 2018
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female patient aged between 18 and 55 years.
- External condylomas, 2-30 lesions (no more than 2 lesions side by side); flat or papular, but not pediculated.
- Lesions must not be internal. Lesions that originate internally, but are visible externally will be considered internal and are not allowed in the study.
- Total wart area (diameter x diameter) should not be less than 10mm2 and not more than 800 mm2
- Individual wart area should not measure more than 50mm2, and the major perpendicular diameter should not measure more than 10mm (1cm).
- Lesions to be treated should have appeared between 1 to 6 months before screening, and patients should not have received any previous condyloma treatment during the last 2 months before enrollment.
- For female patients: either postmenopausal, taking adequate contraceptive method or surgically sterile.
Who cannot join
- Patients should not have received genital wart treatment for previous condylomas (other than the prior treatment for current condylomas referred at inclusion criteria) in the last 12 months before enrollment
- Patients with any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease, transplanted or immunosuppressed patients or other clinical condition that, in the Investigator's judgment, prevents the patients from participating to the study.
- Patients with any clinically significant abnormality following review of screening laboratory tests, vital signs, full physical examination and ECG.
- Patients with history or presence of drug or alcohol abuse.
- Patients with positive HBs or HBc antigen or anti HCV antibody, or positive results for HIV 1 or 2 tests.
- Patients using any dermatological drug therapy in the treatment area during the last month prior the first application of the study drug.
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Argentina5 sites
Anaconda Invesigational Site
Buenos Aires
Anaconda Investigational Site
Buenos Aires
Anaconda Investigational Site
Córdoba
Anaconda Investigational Site
Mendoza
Anaconda Investigational Site
Sante Fe
Ecuador3 sites
Anaconda Investigational Site
Cumbayá
Anaconda Investigational Site
Guayaquil
Anaconda Investigational Site
Quito
Chile2 sites
Anaconda Investigational Site
Concepción
Anaconda Investigational Site
Santiago
Serbia2 sites
Anaconda Investigational Site
Belgrade
Anaconda Investigational Site
Novi Sad
About this study
Official title: A Double-blind Placebo Controlled, Randomized, Phase II Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Topical Applications of AP611074 5% Gel for up to 16 Weeks in Condyloma Patients
This is a double-blind placebo controlled, randomized, phase 2 study to assess the safety, tolerability, pharmacokinetics and efficacy of twice daily topical applications of AP611074 5% Gel for up to 16 weeks in condyloma patients
- Conditions
- Condyloma
- Being tested
- AP611074 5% gel, AP611074 matching placebo
- Keywords
- Genital warts, HPV types, Sexually Transmitted Disease, Papillomavirus Infections, Viral Disease, Anogenital warts, AGW, HPV6, HPV11, Human papillomavirus infection, HPV, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen
- Medical subject headings
- Condylomata Acuminata, Sexually Transmitted Diseases, Papillomavirus Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP611074 5% gelDrug
AP611074 matching placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| AP611074 5% gel | Experimental | 100 mg twice daily doses of AP611074 5% gel Receives: Drug: AP611074 5% gel |
| Placebo | Placebo comparator | AP611074 matching placebo gel Receives: Drug: AP611074 matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with at least one local skin reaction (LSR)
Measured: Day 0 to Week 16
Number of patients experiencing adverse events
Measured: Day 0 to Week 16
Mean plasma concentrations of AP611074-04
Measured: Day 0 to 2 weeks post end of treatment
Secondary outcomes (4)
Proportion of subjects with a complete clearance rate (100%) for baseline genital wart lesions
Measured: Day 0 to week 16
Reduction in the total condyloma area for lesions
Measured: Day 0 to week 16
Proportion of subjects with a complete clearance rate (100%) for all genital wart lesions
Measured: Day 0 to week 16
Time to complete clearance
Measured: Day 0 to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CondylomaStudies 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
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaxart
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Novotney-Barry, Study director, Aviragen Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724254
- Sponsor's protocol ID
- AP611074.CT4
- Status last verified
- Jul 2018
- First submitted
- 21 Mar 2016
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Placebo Controlled, Randomized, Phase II Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Topical Applications of AP611074 5% Gel for up to 16 Weeks in Condyloma Patients
- ClinicalTrials.gov ID
- NCT02724254
- Acronym / sponsor ID
- AP611074.CT4
- Conditions
- Condyloma
- Keywords
- Genital warts, HPV types, Sexually Transmitted Disease, Papillomavirus Infections, Viral Disease, Anogenital warts, AGW, HPV6
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- VaxartIndustry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 31 Mar 2016 (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.
This is a double-blind placebo controlled, randomized, phase 2 study to assess the safety, tolerability, pharmacokinetics and efficacy of twice daily topical applications of AP611074 5% Gel for up to 16 weeks in condyloma patients
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 |
|---|---|---|
| AP611074 5% gel | Experimental | Drug: AP611074 5% gel100 mg twice daily doses of AP611074 5% gel |
| Placebo | Placebo comparator | Drug: AP611074 matching placeboAP611074 matching placebo gel |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female patient aged between 18 and 55 years.
- External condylomas, 2-30 lesions (no more than 2 lesions side by side); flat or papular, but not pediculated.
- Lesions must not be internal. Lesions that originate internally, but are visible externally will be considered internal and are not allowed in the study.
- Total wart area (diameter x diameter) should not be less than 10mm2 and not more than 800 mm2
- Individual wart area should not measure more than 50mm2, and the major perpendicular diameter should not measure more than 10mm (1cm).
Key exclusion criteria (6 listed)
- Patients should not have received genital wart treatment for previous condylomas (other than the prior treatment for current condylomas referred at inclusion criteria) in the last 12 months before enrollment
- Patients with any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease, transplanted or immunosuppressed patients or other clinical condition that, in the Investigator's judgment, prevents the patients from participating to the study.
- Patients with any clinically significant abnormality following review of screening laboratory tests, vital signs, full physical examination and ECG.
- Patients with history or presence of drug or alcohol abuse.
- Patients with positive HBs or HBc antigen or anti HCV antibody, or positive results for HIV 1 or 2 tests.
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 |
|---|---|---|
| AP611074 5% gel | Drug | AP611074 5% gel |
| AP611074 matching placebo | Drug | Placebo |
Primary outcome
Percentage of patients with at least one local skin reaction (LSR)
Time frame: Day 0 to Week 16
Number of patients experiencing adverse events
Time frame: Day 0 to Week 16
Mean plasma concentrations of AP611074-04
Time frame: Day 0 to 2 weeks post end of treatment
4 secondary outcomes
Proportion of subjects with a complete clearance rate (100%) for baseline genital wart lesions
Time frame: Day 0 to week 16
Reduction in the total condyloma area for lesions
Time frame: Day 0 to week 16
Proportion of subjects with a complete clearance rate (100%) for all genital wart lesions
Time frame: Day 0 to week 16
Time to complete clearance
Time frame: Day 0 to week 16
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 20 Jul 2018.
Related trials for Condyloma
Not yet recruiting
Efficacy and Safety of Oral Ivermectin for Genital Warts
Genital Warts
RecruitingPhase 2
Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
HPV (Human Papillomavirus)-Associated, Genital Warts
RecruitingObservational study
Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
Psoriasis, Condyloma Acuminata
Not yet recruitingEarly Phase 1
the Efficacy of Ivermectin Alone or With Microneedling in Treatment of Cutaneous Warts.
Warts
RecruitingPhase 2
To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years
HPV Infection, HPV-Related Carcinoma
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.
Anna Novotney-Barry study director
Aviragen Therapeutics, Inc.
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AP611074 5% gel in people with Condyloma, run by Vaxart at 12 sites in 4 countries.
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 6 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 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Argentina, Ecuador, Chile, Serbia. 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?
Percentage of patients with at least one local skin reaction (LSR) (time frame: Day 0 to Week 16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2018.