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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Labo'Life Belgium

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Trial duration

9 May 2024 → ongoing

Decision date (initial)

2024-05-08

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Labo'life

External identifiers

EU CT number

2024-513969-39-00

EudraCT number

2017-004346-22

ClinicalTrials.gov

NCT04232917

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Comparison of the efficacy of 2LPAPI® versus placebo on the clearance of genital HR-HPV infections after 12 months of follow-up.

Secondary objectives 1

1. 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.

Conditions and MedDRA coding

Human Papillomavirus infection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. - 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 1

1. - 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,

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. HR-HPV infection clearance at 12-month visit.

Secondary endpoints 1

1. - 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Labo'Life Belgium

Sponsor organisation

Labo'Life Belgium

Address

Avenue D'Ecolys 2 Bus 36

City

Namur

Postcode

5020

Country

Belgium

Scientific contact point

Organisation

Labo'Life Belgium

Contact name

Laura Ferté Clinical Project Manager

Public contact point

Organisation

Labo'Life Belgium

Contact name

Laura Ferté Clinical Project Manager

Locations

2 EU/EEA countries · 19 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 30 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications