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Active, Not Recruiting

NCT Number: NCT06491446

Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Human Papillomavirus Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

25 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

PARC Clinical Research, Royal Adelaide Hospital, Adelaide, South Australia, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABI-2280

Drug

Different strength of ABI 2280 will be administered in different cohorts.

Other: Placebo Matching placebo will be administered.

Primary outcomes

  1. For sentinel cohorts: Incidence and Severity of Adverse Events

    Time frame: Week 24

    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

  2. For fully expanded cohorts, including sentinel: Clearance of persistent cervical hrHPV infection as defined by the absence of all hrHPV genotypes present at baseline

    Time frame: Week 12

    Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders.

Secondary outcomes

  1. For fully expanded cohorts, including sentinel: Incidence and Severity of Adverse Events

    Time frame: Week 24

    For fully expanded cohorts, including sentinel: for each dose/dosing regimen, incidence and severity of AEs, relationship of AEs to IP, and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo.

  2. Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders

    Time frame: Week 24

    For fully expanded cohorts, including sentinel: For each dose/dosing regimen, proportion of participants who received ABI-2280 Vaginal Insert vs. pooled placebo who are complete responders, defined as the absence of all hrHPV genotypes that were present at baseline, at Week 24

Sponsors and collaborators

Lead sponsor

Antiva Biosciences

Industry

Registry information

Official study title

A Randomized, Placebo-Controlled Study to Evaluate Clearance of High-Risk Human Papillomavirus and Safety After Administration of ABI-2280 Vaginal Inserts

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 9, 2024
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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