Efficacy Evaluation of Interferon Alfa, Interleukin-1, Interleukin-2, and Nucleic Acid Combination in Non-Genital Warts: A Randomized, Double-Blind, Placebo-Controlled Trial

The primary objective of this randomized, placebo-controlled, double-blind study is to evaluate the **efficacy** of 2LVERU®JUNIOR and 2LVERU® in the treatment of **non-genital warts infection**. The study aims to compare the disappearance of warts at the end of a 6-month treatment period between the active treatment groups and the placebo group. This is clinically relevant as it seeks to establish the effectiveness of these treatments in reducing wart burden, which can significantly impact patient quality of life.

Secondary objectives include: - Comparison of the efficacy of the treatment on the disappearance of warts at 4 months between groups. - Evaluation of the treatment's efficacy on the level of disappearance (across 4 levels) of warts at 4 and 6 months. - Assessment of the recurrence of warts 3 months post-treatment. - Comparison of pain associated with warts during the study between groups. - Evaluation of safety issues.

The clinical trial focuses on evaluating the efficacy of treatments for **non-genital warts infection**. The study population includes both male and female participants aged 3 years and older. Participants are required to have common warts (Verruca vulgaris), plantar warts (Verruca plantaris), or flat warts (Verruca plana). The trial does not involve a vulnerable population. Participants, or their parents if necessary, must have the ability to understand and comply with the study requirements, and informed consent must be obtained. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet or physical activity.

The clinical trial is designed as a **randomized, double-blind, placebo-controlled** study to evaluate the efficacy of 2LVERU® JUNIOR and 2LVERU® in the treatment of **non-genital warts infection**. The trial aims to compare the disappearance of warts at the end of a 6-month treatment period between the active treatment groups and the placebo group. The study involves participants aged 3 years and older who have common warts, plantar warts, or flat warts. The trial is expected to run from February 17, 2020, to June 15, 2026, with a maximum treatment period of 6 months for each participant.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on the inclusion criteria, which include the ability to understand and comply with study requirements and the signing of an informed consent form. Following the screening, participants will be randomized to receive either the active treatment or placebo. The study drug is administered via **oromucosal use** in the form of granules in capsules to be opened. The primary endpoint is the disappearance of warts at the 6-month visit, while secondary endpoints include the disappearance of warts at 4 months, evaluation of pain using a visual analog scale, and the occurrence of adverse events.

Follow-up visits will occur at regular intervals to monitor the progress of treatment, assess the disappearance level of warts, and evaluate any recurrence of warts at a 3-month post-treatment visit. The end-of-study visit will conclude the participant's involvement, assessing the final outcomes and any adverse events. Participants may be withdrawn from the study early if they experience severe adverse events or if they are unable to comply with the study protocol. The trial is conducted under strict adherence to ethical guidelines, ensuring the safety and well-being of all participants throughout the study duration.

The clinical trial involves the administration of **2LVERU JUNIOR** and **2LVERU** as experimental medications. Both formulations are presented as granules in capsules designed to be opened, with the pharmaceutical form classified as pillules. The active substances in these medications include **interferon alfa**, **interleukin-1**, **interleukin-2** (also known as IL-2), **ribonucleic acid**, **specific nucleic acid SNA-HLA II**, and **specific nucleic acid SNA-VERU**. These substances are derived from proteins and nucleic acids. The maximum daily dose for both formulations is 380 mg, with a total maximum dose of 68.4 g over a treatment period of up to six months. The route of administration is oromucosal, and the medications are produced by Labo'Life Belgium.

The trial also includes a **placebo** group to serve as a comparator. The placebo is not associated with any active substances and does not have a specified pharmaceutical form or route of administration. It is used to evaluate the efficacy of the experimental treatments by providing a baseline for comparison.

The efficacy of the clinical trial will be assessed by evaluating the primary endpoint, which is the **disappearance of warts** at the end of the treatment period, specifically at the 6-month visit. This endpoint will be measured by comparing the outcomes between the treatment groups receiving 2LVERU® JUNIOR and 2LVERU® versus the placebo group. Secondary endpoints include the disappearance of warts at 4 months, the level of disappearance (total, partial at 50%, no modification, or increase in the number of warts) at both 4 and 6 months, and the recurrence of warts at a 3-month post-treatment visit. Additionally, pain evaluation will be conducted using the Visual Analogue Scale (VAS), and the consumption of analgesic medication will be monitored. Safety assessments will include the occurrence of adverse events (AEs) and severe adverse events (SAEs), whether related or unrelated to the study drug.