Papilozumib Vaginal Gel for Exocervical Mucosal Restoration in Women With Human Papillomavirus (HPV)

Exocervical mucosal restoration will be assessed by colposcopy using the 5-point scale: 1, severe ectopia with bleeding; 2, severe or extensive ectopia involving more than 50%; 3, moderate ectopia involving 25% to 50%; 4, mild ectopia involving less than 25%; and 5, no ectopia. Higher scores indicate greater mucosal restoration. The Day 30 assessment applies to the vaginal gel plus oral supplement arm and the usual clinical practice arm. Month 3 and Month 6 assessments apply to all study arms.

The investigator will record whether the cervical cytology result is concordant with the colposcopic finding using a Yes or No response. The outcome will be reported as the percentage of participants with concordant findings. The Day 30 assessment applies to Arms B and C, and the Month 3 and Month 6 assessments apply to all arms.

Among participants with abnormal cervical cytology at baseline, normalization is defined as a change from atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), or atypical glandular cells (AGC) to normal cervical cytology, with a concordant colposcopic finding. The reported outcome will be the percentage of participants meeting this combined definition of cytological normalization; colposcopic concordance will not be reported as a separate measurement within this outcome.

Complete human papillomavirus clearance will be assessed using genotyped polymerase chain reaction (PCR) testing. Complete clearance is defined as a negative HPV test or disappearance of all HPV genotypes detected at baseline. The reported value will be the percentage of participants meeting the definition of complete HPV clearance.

Partial human papillomavirus clearance will be assessed using genotyped polymerase chain reaction (PCR) testing. Partial clearance is defined as disappearance of at least one HPV genotype detected at baseline. The reported value will be the percentage of participants meeting the definition of partial HPV clearance.

Vaginal health will be assessed using the Bachmann Vaginal Health Index. The change from the baseline score will be calculated at each follow-up assessment.

Participants in the two treatment arms will rate their satisfaction with the assigned treatment using a 7-point response scale ranging from 1, satisfied, to 7, not at all satisfied. Lower scores indicate greater satisfaction.

Adherence to Papilozumib vaginal gel will be assessed in participants assigned to Arms A and B using treatment dispensing and return records and the participant treatment calendar. Vaginal gel adherence will be categorized as poor, less than 50%; moderate, 50% to less than 75%; good, 75% to less than 90%; or very good, 90% or greater.

Adherence to the Papilozumib oral supplement will be assessed in participants assigned to Arm B using treatment dispensing and return records and the participant treatment calendar. Oral supplement adherence will be categorized as poor, less than 50%; moderate, 50% to less than 75%; good, 75% to less than 90%; or very good, 90% or greater.

Safety will be assessed as the number of participants who experience at least one adverse event after randomization. A participant will be counted once in this outcome regardless of the number of adverse events experienced. Characteristics of individual adverse events, including their nature and severity, will be evaluated descriptively and are not separate measurements within this Outcome Measure.

Participants in the two treatment arms will rate tolerability using a 5-point scale: 1, very good; 2, good; 3, neutral; 4, poor; and 5, very poor. Arm A participants will rate the vaginal gel, and Arm B participants will rate the vaginal gel plus oral supplement combination. Lower scores indicate better tolerability.