Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABI-2280 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (11)
- type
- ACTIVE_COMPARATOR
- label
- Experimental: Cohort 1
- description
- Participants in this arm will receive either ABI 2280 (Dose 1) or matching placebo
- interventionNames
- Drug: ABI-2280
- type
- ACTIVE_COMPARATOR
- label
- Experimental: Cohort 2
- description
- Participants in this arm will receive either ABI 2280 (Dose 2) or matching placebo
- interventionNames
- Drug: ABI-2280
- type
- ACTIVE_COMPARATOR
- label
- Experimental: Cohort 3
- description
- Participants in this arm will receive either ABI 2280 (Dose 3) or matching placebo
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available