NCT03697226

Brief Summary

This study evaluates the use of ABI-1968, a topical cream, in the treatment of cervical precancerous lesions in females without human immunodeficiency virus (HIV) infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

December 21, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2020

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2020

Completed
Last Updated

January 13, 2021

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

September 25, 2018

Last Update Submit

January 11, 2021

Conditions

HSIL of CervixHSIL, High Grade Squamous Intraepithelial LesionsHigh-Grade Cervical Intraepithelial NeoplasiaHuman Papilloma VirusHIV NegativeCervical CancerCIN - Cervical Intraepithelial NeoplasiaCervical NeoplasmCervical Dysplasia

Outcome Measures

Primary Outcomes (1)

  • Safety & Tolerability of ABI-1968 for the treatment of cHSIL

    Number of Adverse Events related to treatment

    42 days

Secondary Outcomes (1)

  • Systemic exposure to ABI-1968 Topical Cream following topical application to the cervix.

    42 days

Other Outcomes (2)

  • Histopathology of areas with biopsy-proven disease

    42 days

  • Changes in HPV viral load following multiple doses of ABI-1968 Topical Cream

    42 days

Study Arms (5)

Dose 1

EXPERIMENTAL

Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22

Drug: Topical ABI-1968

Dose 2

EXPERIMENTAL

Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22

Drug: Topical ABI-1968

Dose 3

EXPERIMENTAL

New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22

Drug: Topical ABI-1968

Dose 4

EXPERIMENTAL

New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22

Drug: Topical ABI-1968

Dose 5

EXPERIMENTAL

New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22

Drug: Topical ABI-1968

Interventions

Topical ABI-1968DRUG

Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts

Dose 1Dose 2Dose 3Dose 4Dose 5

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women, 25 to 50 years old.
  • Biopsy-confirmed cervical HSIL that is p16+ within 60 days of enrollment (dosing) with no evidence of invasive cancer in any specimen.
  • Colposcopy is satisfactory based on visualization of the entire squamo-columnar junction (SCJ). The borders of all lesions must be completely visible.
  • The upper limit of the visible (usually aceto-white) lesion is within 3 quadrants or less at screening.

You may not qualify if:

  • Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
  • HIV positive (tested at screening visit or within 3 months of screening visit).
  • Resolution of visible CIN lesion prior to enrollment.
  • ECC positive for glandular disease (adenocarcinoma in situ) or invasive cancer.
  • History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Center

Bloemfontein, Free State, 9301, South Africa

Location

MeSH Terms

Conditions

Squamous Intraepithelial LesionsUterine Cervical NeoplasmsUterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Morphological and Microscopic FindingsPathological Conditions, Signs and SymptomsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPrecancerous Conditions

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2018

First Posted

October 5, 2018

Study Start

December 21, 2018

Primary Completion

May 26, 2020

Study Completion

June 12, 2020

Last Updated

January 13, 2021

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)