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

Browse trials for

• Papillomavirus Infections 495
• Sexually Transmitted Diseases 424

Keywords

• HPV
• sexually-transmitted infection
• high-risk HPV
• CIN

Papillomavirus Infections

495 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.

This study's enrollment of 141 is below the median of 202 across 332 interventional studies indexed under Papillomavirus Infections.

Lead sponsor

Antiva Biosciences is the lead sponsor of 6 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Study arms

• Active comparator
  Experimental: Cohort 1

  Participants in this arm will receive either ABI 2280 (Dose 1) or matching placebo

  Drug: ABI-2280

• Active comparator
  Experimental: Cohort 2

  Participants in this arm will receive either ABI 2280 (Dose 2) or matching placebo

  Drug: ABI-2280

• Active comparator
  Experimental: Cohort 3

  Participants in this arm will receive either ABI 2280 (Dose 3) or matching placebo

  Drug: ABI-2280

• Active comparator
  Experimental: Cohort 4

  Participants in this arm will receive either ABI 2280 (Dose 4) or matching placebo

  Drug: ABI-2280

• Active comparator
  Experimental: Cohort 5

  Participants in this arm will receive either ABI 2280 (Dose 5) or matching placebo

  Drug: ABI-2280

• Active comparator
  Experimental: Cohort 6

  Participants in this arm will receive either ABI 2280 (Dose 6) or matching placebo

  Drug: ABI-2280

• Active comparator
  Experimental: Cohort 7

  Participants in this arm will receive either ABI 2280 (Dose 7) or matching placebo

  Drug: ABI-2280

• Active comparator
  Experimental: Cohort 8

  Participants in this arm will receive either ABI 2280 (Dose 8) or matching placebo

  Drug: ABI-2280

• Active comparator
  Experimental: Cohort 9

  Participants in this arm will receive either ABI 2280 (Dose 9) or matching placebo

  Drug: ABI-2280

• Active comparator
  Experimental: Cohort 10

  Participants in this arm will receive either ABI 2280 (Dose 10) or matching placebo

  Drug: ABI-2280

• Active comparator
  Experimental: Cohort 11

  Participants in this arm will receive either ABI 2280 (Dose 11) or matching placebo

  Drug: ABI-2280

Interventions

• DrugABI-2280

  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

   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

   Time frame: Week 24

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

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

   Time frame: Week 12

Secondary outcomes

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

   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.

   Time frame: Week 24

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

   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

   Time frame: Week 24