Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LPAPI® on the clearance of high-risk oncogenic HPV genital infections (PAPION study)

Phase 1

Active, not recruiting

• Conditions: Human Papillomavirus infection; MedDRA version: 25.0Level: LLTClassification code: 10086966Term: HPV screening Class: 100000004848; MedDRA version: 25.0Level: LLTClassification code: 10086964Term: HPV infection Class: 100000004848; MedDRA version: 20.0Level: SOCClassification code: 10038604Term: Reproductive system and breast disorders Class: 20; MedDRA version: 20.0Level: SOCClassification code: 10021881Term: Infections and infestations Class: 1; Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

• Registration Number: CTIS2024-513969-39-00
• Lead Sponsor: abo'Life Belgium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-29
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 284

Inclusion Criteria

Women between 25 and 45 years old; - Women of childbearing age under effective contraception; - Patient with last cytology less than 3 years and normal or not more than LSIL or CIN I at the histology - Patient with current cytology presenting normal, ASC-US, AGUS, LSIL, ASC-H, AGC, LSIL+ASC-H results or current diagnosis of CIN I at the histology; - Patient with HR-HPV diagnosis at the current cervical collection; - Patient reporting a current stable sexual relationship (steady sexual partner for the duration of the study); - Patient having the ability to understand and respect the constraints of the study; - Signature of the Informed Consent Form.

Exclusion Criteria

- Pregnant or breastfeeding women; - Patient presenting HSIL diagnosis at the cytology or CIN II or CIN III diagnosis at the histology; - Patient having received HPV vaccination in the last month; - Patient previously subject to a total hysterectomy; - Patient under immunotherapy treatment (including immunosuppressive treatments) or micro-immunotherapy received in the last six months; - Patient with known lactose intolerance; - Patient who has participated in a clinical study in the last three months; - Patient not sufficiently motivated to engage in a 12-month follow-up, or likely to travel or move before the end of the study; - Patient with severe immune deficiency requiring long-term treatment (*) or under chemotherapy or radiotherapy; - Patient under listed homeopathic or phytotherapy treatment (see list in the protocol); - Patient using or addicted to recreational drugs. (*) important renal or respiratory failure,

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Comparison of the efficacy of 2LPAPI® versus placebo on the clearance of genital HR-HPV infections after 12 months of follow-up.;Secondary Objective: Comparison of 2LPAPI® versus placebo on: - HR-HPV infection clearance rate at 6-month visit; - HR-HPV infection clearance rate by HPV type at 6-month and 12-month visits; - Evolution of cytology; - Normalization of cytology for the subpopulation of patients with a baseline non normal cytology, - Safety: adverse events (AEs) and serious adverse events (SAEs) considered as related or not to the study drug.;Primary end point(s): HR-HPV infection clearance at 12-month visit.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):- HR-HPV infection clearance at 6-month visit; - HR-HPV infection clearance by HPV type at 6-month and 12-month visits; - Evolution of cytology (normalization, stagnation or aggravation) at 6-month and 12-month visits; - Normalization of cytology at 6-month and 12-month visits for the subpopulation of patients with a baseline non normal cytology, - Safety: adverse events (AEs) and serious adverse events (SAEs) considered as related or unrelated to the study drug.