Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts
A Randomized, Placebo-Controlled Study to Evaluate Clearance of High-Risk Human Papillomavirus and Safety After Administration of ABI-2280 Vaginal Inserts
1 other identifier
interventional
141
4 countries
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2024
Typical duration for phase_1
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 27, 2024
CompletedFirst Submitted
Initial submission to the registry
July 1, 2024
CompletedFirst Posted
Study publicly available on registry
July 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedFebruary 18, 2026
February 1, 2026
1.6 years
July 1, 2024
February 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
For sentinel cohorts: Incidence and Severity of Adverse Events
For sentinel cohorts: for each dose/dosing regimen, incidence and severity of adverse events (AEs), relationship of AEs to investigational product (IP), and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo
Week 24
For fully expanded cohorts, including sentinel: Clearance of persistent cervical hrHPV infection as defined by the absence of all hrHPV genotypes present at baseline
Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders.
Week 12
Secondary Outcomes (2)
For fully expanded cohorts, including sentinel: Incidence and Severity of Adverse Events
Week 24
Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders
Week 24
Study Arms (11)
Experimental: Cohort 1
ACTIVE COMPARATORParticipants in this arm will receive either ABI 2280 (Dose 1) or matching placebo
Experimental: Cohort 2
ACTIVE COMPARATORParticipants in this arm will receive either ABI 2280 (Dose 2) or matching placebo
Experimental: Cohort 3
ACTIVE COMPARATORParticipants in this arm will receive either ABI 2280 (Dose 3) or matching placebo
Experimental: Cohort 4
ACTIVE COMPARATORParticipants in this arm will receive either ABI 2280 (Dose 4) or matching placebo
Experimental: Cohort 5
ACTIVE COMPARATORParticipants in this arm will receive either ABI 2280 (Dose 5) or matching placebo
Experimental: Cohort 6
ACTIVE COMPARATORParticipants in this arm will receive either ABI 2280 (Dose 6) or matching placebo
Experimental: Cohort 7
ACTIVE COMPARATORParticipants in this arm will receive either ABI 2280 (Dose 7) or matching placebo
Experimental: Cohort 8
ACTIVE COMPARATORParticipants in this arm will receive either ABI 2280 (Dose 8) or matching placebo
Experimental: Cohort 9
ACTIVE COMPARATORParticipants in this arm will receive either ABI 2280 (Dose 9) or matching placebo
Experimental: Cohort 10
ACTIVE COMPARATORParticipants in this arm will receive either ABI 2280 (Dose 10) or matching placebo
Experimental: Cohort 11
ACTIVE COMPARATORParticipants in this arm will receive either ABI 2280 (Dose 11) or matching placebo
Interventions
Different strength of ABI 2280 will be administered in different cohorts. Other: Placebo Matching placebo will be administered.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
PARC Clinical Research, Royal Adelaide Hospital
Adelaide, South Australia, Australia
Emeritus Research Camberwell
Camberwell, Australia
Holdsworth House Medical Practice
Darlinghurst, Australia
KIMR
Nedlands, Australia
The Royal Women's Hospital
Parkville, Australia
Emeritus Research Sydney
Sydney, Australia
AusTrials Taringa
Taringa, Australia
AusTrials Wellers Hill
Tarragindi, Australia
International Cancer Institute
Eldoret, 8088-30100, Kenya
Victoria Cancer Care & Research Centres
Kisii, 1376-40500, Kenya
Kenya Medical Research Institute (KEMRI) - RCTP Kisumu
Kisumu, 614-40100, Kenya
Victoria Biomedical Research Institute
Kisumu, 7180-40100, Kenya
Arke Estudios Clinicos S.A. De C.V.
Cuauhtémoc, CP 06700, Mexico
Centro Oncologico Internacional
Mexico City, CP 04700, Mexico
Unidad de Medicina Especializada SMA
Querétaro, CP 76800, Mexico
FAICIC S. de R.L. de C.V.
Veracruz, CP 91900, Mexico
Waitemata Clinical Research Ltd
Birkenhead, New Zealand
P3 Research Dunedin
Dunedin, New Zealand
P3 Research Hawke's Bay
Hastings, New Zealand
P3 Research Lower Hutt
Lower Hutt, New Zealand
Pacific Clinical Trials Network - Tasman
Nelson, New Zealand
P3 Research Kapiti
Paraparaumu, New Zealand
Lakeland Clinical Trials
Rotorua, New Zealand
Clinical Horizons New Zealand
Tauranga, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blind masking
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2024
First Posted
July 9, 2024
Study Start
March 27, 2024
Primary Completion
October 16, 2025
Study Completion (Estimated)
June 30, 2026
Last Updated
February 18, 2026
Record last verified: 2026-02