Efficacy and Safety Evaluation of Ianalumab in Moderate to Severe Hidradenitis Suppurativa: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study

The primary objective of this study is to evaluate the **efficacy** of investigational treatments compared to placebo in patients with moderate to severe inflammatory **hidradenitis suppurativa** (HS). This is clinically relevant as it aims to determine the potential therapeutic benefits of new treatments in managing a condition characterized by painful nodules and abscesses, which significantly impact patients' quality of life.

Secondary objectives include assessing the **safety** and **tolerability** of the investigational treatments in the same patient population. These objectives are crucial for understanding the risk-benefit profile of the treatments, ensuring that any therapeutic gains do not come at the expense of patient safety.

The clinical trial involves a total of **98 participants** diagnosed with **moderate to severe hidradenitis suppurativa**. The study population comprises both male and female subjects, aged between **18 to 65 years**. Participants were selected based on a clinical diagnosis of hidradenitis suppurativa for at least 12 months prior to screening. The trial includes individuals with a minimum of 5 inflammatory lesions, such as abscesses and/or inflammatory nodules, for certain cohorts, and at least 3 for others. Additionally, participants must have no more than 15 fistulae and involvement of at least two anatomical areas with hidradenitis suppurativa lesions. The trial population includes a vulnerable group, indicating careful consideration of ethical standards in participant selection. Lifestyle factors such as diet and physical activity were not specified by the sponsor.

The clinical trial is designed to evaluate the **efficacy** and safety of investigational drugs in patients with moderate to severe **hidradenitis suppurativa**. This is a randomized, double-blind, placebo-controlled, multi-center study. The trial is structured to include several cohorts, each receiving different investigational treatments or a placebo. The primary objective is to assess the proportion of patients achieving a clinical response as evaluated by the simplified Hidradenitis Suppurativa Clinical Response (HiSCR) after 16 weeks of treatment. Secondary endpoints include the number and severity of adverse events, as well as assessments of physical examination, vital signs, safety laboratory measurements, and ECGs.

The trial is expected to run from June 2019 to October 2026, with participant involvement lasting up to 16 weeks. The study begins with a screening visit to confirm eligibility based on criteria such as age, disease duration, and the number of inflammatory lesions. Participants must be between 18 to 65 years old and have a clinically diagnosed condition for at least 12 months prior to screening. Follow-up visits are scheduled throughout the treatment period to monitor safety and efficacy, with the final visit marking the end of the study for each participant. Conditions that may lead to early termination from the study include the occurrence of significant adverse events or withdrawal of consent by the participant.

The investigational product, VAY736, is administered as a **solution for infusion** via subcutaneous use. A placebo solution is also used for control purposes. The trial is not classified as a low-intervention study and is categorized as a Phase 2-3 trial. Participants are randomly assigned to receive either the investigational drug or placebo, ensuring the study's double-blind nature. The trial's design aims to provide robust data on the investigational treatments' safety and efficacy, contributing to the understanding and management of moderate to severe hidradenitis suppurativa.

The clinical trial involves the administration of **VAY736**, an investigational medication, which is a **solution for infusion**. The active substance in VAY736 is **ianalumab**, a protein-based therapeutic agent classified as an immunoglobulin G1 monoclonal antibody. The pharmaceutical form of VAY736 is a solution intended for **subcutaneous use**. The dosing regimen for VAY736 is determined by the study protocol, with a maximum treatment period of 16 weeks. The specific dosage and frequency of administration are not detailed in the provided data. Participant compliance with the dosing schedule will be monitored throughout the trial to ensure adherence to the protocol.

In addition to the investigational drug, a **placebo solution** is used as a comparator in this study. The placebo is described as a solution for injection or infusion with no active substance, labeled as "Placebo Solution for injection or infusion 0 mg/1 mL." The placebo serves as a control to assess the efficacy and safety of VAY736 in patients with moderate to severe **hidradenitis suppurativa**. The administration route and dosing schedule for the placebo are aligned with those of the investigational drug to maintain blinding and consistency in the trial design.

The efficacy of the investigational treatments in the clinical trial will be assessed by evaluating the primary endpoint, which is the proportion of patients achieving a clinical response as measured by the simplified Hidradenitis Suppurativa Clinical Response (HiSCR) after 16 weeks of treatment. This endpoint is designed to quantify the improvement in patients with moderate to severe **hidradenitis suppurativa**. The HiSCR is a validated tool used to assess clinical response in this patient population.

Secondary endpoints will include the number and severity of adverse events, as well as assessments from physical examinations, vital signs, safety laboratory measurements, and electrocardiograms (ECGs). These parameters will be collected and analyzed to provide a comprehensive evaluation of the treatment's safety and efficacy profile. The trial is structured as a randomized, subject and investigator-blinded, placebo-controlled, multi-center platform study, ensuring robust and reliable data collection and analysis.