Clinical trial NCT06491446: Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts
Official title: A Randomized, Placebo-Controlled Study to Evaluate Clearance of High-Risk Human Papillomavirus and Safety After Administration of ABI-2280 Vaginal Inserts
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Human Papillomavirus Infection
Keywords: HPV
sexually-transmitted infection
high-risk HPV
CIN
Lead sponsor: Antiva Biosciences
Sponsor class: INDUSTRY
First posted: 2024-07-09
Enrollment: 160
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a blinded study to assess safety, tolerability, and efficacy of ABI-2280 vaginal inserts in participants diagnosed with persistent cervical hrHPV infection. This study will have up to 11 cohorts with various dose strengths and regimens. Each cohort will start with a sentinel cohort of 8 participants. Sentinel cohorts may be expanded to include an additional up to 32 participants to provide additional proof of concept data to further understanding of benefit/risk of a given dose/dose regimen.

Detailed description: This is a randomized, double-blind, placebo-controlled Phase 1b/2 study in women diagnosed with persistent cervical hrHPV infection. This study is designed to assess safety, tolerability, and efficacy following the use of ABI-2280 Vaginal Insert delivered intravaginally. Sentinel cohorts will be utilized to assess tolerable regimens, which may trigger cohort expansions if some evidence of efficacy is observed.

Dose range and dosing regimens in this study will be evaluated through the enrollment of up to 11 sentinel cohorts, each enrolling up to 8 participants.

Eligibility criteria: Inclusion Criteria

* Female sex, 25 to 55 years of age
* Positive hrHPV result on at least 2 consecutive tests prior to randomization, one hrHPV+ result at least 12 months prior to screening
* Cervical cytology, colposcopy and/or biopsy performed within the last 6 months confirming disease status no greater than low-grade squamous intraepithelial lesions or cervical intraepithelial neoplasia grade 1.

Exclusion Criteria

* History of biopsy or colposcopy indicating high-grade squamous intraepithelial lesions, or history of endocervical curettage positive for glandular dysplasia
* Any clinically significant immune suppressing condition
* History or current diagnosis of cervical cancer, suspected or confirmed
* Plan to have excision or ablation of cervical or vaginal lesions, or to undergo large loop excision of the transformation zone at any time during the study.

Primary outcomes:
measure: For sentinel cohorts: Incidence and Severity of Adverse Events
timeFrame: Week 24
measure: For fully expanded cohorts, including sentinel: Clearance of persistent cervical hrHPV infection as defined by the absence of all hrHPV genotypes present at baseline
timeFrame: Week 12
Secondary outcomes:
measure: For fully expanded cohorts, including sentinel: Incidence and Severity of Adverse Events
timeFrame: Week 24
measure: Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders
timeFrame: Week 24
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: PARC Clinical Research, Royal Adelaide Hospital
state: South Australia
city: Camberwell
country: Australia
facility: Emeritus Research Camberwell
city: Darlinghurst
country: Australia
facility: Holdsworth House Medical Practice
city: Nedlands
country: Australia
facility: KIMR
city: Parkville
country: Australia
facility: The Royal Women's Hospital
city: Sydney
country: Australia
facility: Emeritus Research Sydney
city: Taringa
country: Australia
facility: AusTrials Taringa
city: Tarragindi
country: Australia
facility: AusTrials Wellers Hill
city: Birkenhead
country: New Zealand
facility: Waitemata Clinical Research Ltd
city: Dunedin
country: New Zealand
facility: P3 Research Dunedin
city: Hastings
country: New Zealand
facility: P3 Research Hawke's Bay
city: Lower Hutt
country: New Zealand
facility: P3 Research Lower Hutt
city: Nelson
country: New Zealand
facility: Pacific Clinical Trials Network - Tasman
city: Paraparaumu
country: New Zealand
facility: P3 Research Kapiti
city: Rotorua
country: New Zealand
facility: Lakeland Clinical Trials
city: Tauranga
country: New Zealand
facility: Clinical Horizons New Zealand
Study officials:
References: