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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06491446




Registration number
NCT06491446
Ethics application status
Date submitted
1/07/2024
Date registered
9/07/2024
Date last updated
19/09/2024

Titles & IDs
Public title
Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts
Scientific title
A Randomized, Placebo-Controlled Study to Evaluate Clearance of High-Risk Human Papillomavirus and Safety After Administration of ABI-2280 Vaginal Inserts
Secondary ID [1] 0 0
ABI-2280-401
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Papillomavirus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABI-2280

Active comparator: Experimental: Cohort 1 - Participants in this arm will receive either ABI 2280 (Dose 1) or matching placebo

Active comparator: Experimental: Cohort 2 - Participants in this arm will receive either ABI 2280 (Dose 2) or matching placebo

Active comparator: Experimental: Cohort 3 - Participants in this arm will receive either ABI 2280 (Dose 3) or matching placebo

Active comparator: Experimental: Cohort 4 - Participants in this arm will receive either ABI 2280 (Dose 4) or matching placebo

Active comparator: Experimental: Cohort 5 - Participants in this arm will receive either ABI 2280 (Dose 5) or matching placebo

Active comparator: Experimental: Cohort 6 - Participants in this arm will receive either ABI 2280 (Dose 6) or matching placebo

Active comparator: Experimental: Cohort 7 - Participants in this arm will receive either ABI 2280 (Dose 7) or matching placebo

Active comparator: Experimental: Cohort 8 - Participants in this arm will receive either ABI 2280 (Dose 8) or matching placebo

Active comparator: Experimental: Cohort 9 - Participants in this arm will receive either ABI 2280 (Dose 9) or matching placebo

Active comparator: Experimental: Cohort 10 - Participants in this arm will receive either ABI 2280 (Dose 10) or matching placebo

Active comparator: Experimental: Cohort 11 - Participants in this arm will receive either ABI 2280 (Dose 11) or matching placebo


Treatment: Drugs: ABI-2280
Different strength of ABI 2280 will be administered in different cohorts.

Other: Placebo Matching placebo will be administered.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
For sentinel cohorts: Incidence and Severity of Adverse Events
Timepoint [1] 0 0
Week 24
Primary outcome [2] 0 0
For fully expanded cohorts, including sentinel: Clearance of persistent cervical hrHPV infection as defined by the absence of all hrHPV genotypes present at baseline
Timepoint [2] 0 0
Week 12
Secondary outcome [1] 0 0
For fully expanded cohorts, including sentinel: Incidence and Severity of Adverse Events
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders
Timepoint [2] 0 0
Week 24

Eligibility
Key inclusion 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.
Minimum age
25 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2026
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
PARC Clinical Research, Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Emeritus Research Camberwell - Camberwell
Recruitment hospital [3] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment hospital [4] 0 0
KIMR - Nedlands
Recruitment hospital [5] 0 0
The Royal Women's Hospital - Parkville
Recruitment hospital [6] 0 0
Emeritus Research Sydney - Sydney
Recruitment hospital [7] 0 0
AusTrials Taringa - Taringa
Recruitment hospital [8] 0 0
AusTrials Wellers Hill - Tarragindi
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Camberwell
Recruitment postcode(s) [3] 0 0
- Darlinghurst
Recruitment postcode(s) [4] 0 0
- Nedlands
Recruitment postcode(s) [5] 0 0
- Parkville
Recruitment postcode(s) [6] 0 0
- Sydney
Recruitment postcode(s) [7] 0 0
- Taringa
Recruitment postcode(s) [8] 0 0
- Tarragindi
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Birkenhead
Country [2] 0 0
New Zealand
State/province [2] 0 0
Dunedin
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hastings
Country [4] 0 0
New Zealand
State/province [4] 0 0
Lower Hutt
Country [5] 0 0
New Zealand
State/province [5] 0 0
Nelson
Country [6] 0 0
New Zealand
State/province [6] 0 0
Paraparaumu
Country [7] 0 0
New Zealand
State/province [7] 0 0
Rotorua
Country [8] 0 0
New Zealand
State/province [8] 0 0
Tauranga

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Antiva Biosciences
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT06491446
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ann Warsi
Address 0 0
Country 0 0
Phone 0 0
650-822-1400
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06491446