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A 20-Year-Old immune regulator faces its biggest test against HPV

NCT ID NCT04232917

Disease control Sponsor: Labo'Life Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether 2LPAPI, an immune regulator used for over 20 years, can help clear high-risk genital HPV infections faster than a placebo. Researchers will enroll 284 women aged 25 to 45 with a current high-risk HPV diagnosis. Participants receive either 2LPAPI or a placebo, and the study compares HPV clearance rates at 6 and 12 months. The goal is to see if this treatment can reduce the time women live with an infection that raises cervical cancer risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
2LPAPI, an immune regulator taken as a treatment for high-risk HPV infections
What this could lead to
If it works, 2LPAPI could offer a way to help the body clear high-risk HPV infections, potentially reducing the need for invasive follow-up procedures.
What could go wrong
This is a Phase 4 trial, but HPV often clears on its own, so the placebo group may show similar results. The treatment's immune effects are not fully understood, and it may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 284 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2020

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women 25-45 years, * 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 or 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 during study duration), * Patient having faculties to understand and respect the constraints of the study, * Signature of the Informed Consent Form. Exclusion Criteria: * Pregnant or breastfeeding woman, * 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 total hysterectomy, * Patient under immunotherapy (including immunosuppressive treatment) or micro-immunotherapy received during last previous 6 months, * Patient with known lactose intolerance, * Patient who participated in a clinical study in the previous 3-months' period, * Patient who is not sufficiently motivated to engage in a follow-up period of 12 months, or likely to travel or to move before the end of the study, * Patient with severe immunodeficiency disease requiring long term treatment (\*) or under chemotherapy or radiotherapy, * Patient under listed homeopathic or phytotherapy treatment (see protocol), * Patient using or addicted to recreational drugs. (\*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.

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Conditions

The condition(s) this trial relates to.

human papilloma virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Human papilloma virus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Belgium

    RECRUITING

    Namur, 5000, Belgium

  • CHU Brugmann

    RECRUITING

    Brussels, 1020, Belgium

  • CHU Saint-Pierre

    RECRUITING

    Brussels, 1000, Belgium

  • CHWAPI

    RECRUITING

    Tournai, 7000, Belgium

  • Cabinet privé

    RECRUITING

    Namur, 5000, Belgium

  • Centre Hospital Reine Astrid Malmedy (CHRAM)

    ACTIVE_NOT_RECRUITING

    Malmedy, 4960, Belgium

  • Clinique Saint-Pierre Ottignies (CSPO)

    NOT_YET_RECRUITING

    Ottignies, 1340, Belgium

  • Clinique St Jean

    RECRUITING

    Brussels, 1000, Belgium

  • Hôpital Civil Marie Curie ISPPC

    ACTIVE_NOT_RECRUITING

    Charleroi, 6042, Belgium

  • Spitalul Nicolae Malaxa

    NOT_YET_RECRUITING

    Bucharest, 022448, Romania

  • UCL Namur - site Sainte Elisabeth

    RECRUITING

    Namur, Belgium

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