Efficacy, Safety, and Tolerability of Tibulizumab in Adults with Hidradenitis Suppurativa: A Phase 2 Randomized, Placebo-Controlled, Multi-Center Study

The primary objective of this phase 2, multi-center study is to evaluate the effect of **tibulizumab** on lesions in patients with **hidradenitis suppurativa** (HS). This is clinically relevant as it aims to determine the therapeutic potential of tibulizumab in reducing the severity and extent of HS lesions, which are a significant source of morbidity in affected individuals.

Secondary objectives include:

• Assessing the effect of tibulizumab on HS-related quality of life in patients with HS, which is important for understanding the broader impact of treatment on patient well-being.
• Evaluating the safety and tolerability of tibulizumab when administered to patients with HS, ensuring that the treatment is not only effective but also safe for patient use.

The clinical trial involves a total of **90 participants** diagnosed with **Hidradenitis Suppurativa**. The study population includes both male and female subjects, aged between 18 to 70 years. Participants were selected based on specific criteria, including a history of the condition for at least six months and an inadequate response or intolerance to oral antibiotics. The trial population is characterized by the presence of HS lesions in at least two distinct anatomical areas, with at least one area classified as Hurley Stage II or III. Participants are required to comply with contraceptive measures if involved in sexual intercourse that could lead to pregnancy. The study does not specify any particular lifestyle considerations such as diet or physical activity. The selection process ensures that participants are willing and able to adhere to all study procedures and visits, and are available for the study's duration.

The clinical trial is a **Phase II** study designed to evaluate the efficacy, safety, and tolerability of **tibulizumab** in adults with **hidradenitis suppurativa**. The trial follows a randomized, placebo-controlled design, with a subsequent open-label extension period. The study is expected to commence recruitment on September 30, 2025, and conclude by February 28, 2027. Participants will be randomly assigned to receive either tibulizumab or a placebo, administered as a **solution for injection** via the **subcutaneous** route. The primary endpoint is the percentage change from baseline in abscess and inflammatory nodule count at Week 16. Secondary endpoints include achieving HiSCR50 and HiSCR75 at Week 16, changes in Dermatology Life Quality Index score, Patient's Global Assessment of Hidradenitis Suppurativa score, and skin pain numerical rating scale, as well as the incidence and severity of treatment-emergent adverse events.

The trial will involve several study visits, beginning with an inclusion (screening) visit to assess eligibility based on criteria such as age, medical history, and previous treatment responses. Participants must have a history of hidradenitis suppurativa for at least six months and meet specific lesion criteria. Following the screening, eligible participants will attend a baseline visit on Day 1, where they will receive their first dose of the study drug. Subsequent follow-up visits will occur at regular intervals to monitor safety, efficacy, and adherence to the study protocol. The end-of-study visit will mark the completion of the trial for each participant, during which final assessments will be conducted.

Participant involvement is expected to last approximately 28 weeks, including the treatment and follow-up periods. Conditions that may lead to early termination from the study include non-compliance with study procedures, withdrawal of consent, or the occurrence of significant adverse events. The trial is conducted in accordance with regulatory guidelines, ensuring the safety and well-being of all participants throughout the study duration.

The clinical trial involves the administration of **Tibulizumab**, an experimental medication, to evaluate its efficacy, safety, and tolerability in adults with **hidradenitis suppurativa**. Tibulizumab is a **solution for injection** and is administered via the **subcutaneous** route. The medication is of biological origin, specifically a protein-based therapeutic. The dosing schedule for Tibulizumab is determined by the study protocol, with a maximum treatment period of 28 days. The exact dosage in milligrams is not specified in the provided data, and the trial does not indicate a maximum daily or total dose amount. Compliance with the dosing regimen is monitored throughout the study to ensure adherence to the protocol.

In addition to the experimental treatment, the study includes a **placebo** group to serve as a comparator. The placebo is referred to as "Tibulizumab Placebo" in the trial documentation. However, specific details regarding the pharmaceutical form, active substance, and route of administration for the placebo are not provided. The placebo is utilized during the randomized, placebo-controlled period of the study to assess the true effect of Tibulizumab by comparing outcomes between the treatment and placebo groups. The use of a placebo is a standard practice in clinical trials to ensure the reliability and validity of the study results.

The efficacy of Tibulizumab in the treatment of **hidradenitis suppurativa** will be assessed through a series of predefined endpoints. The primary endpoint is the percentage change from baseline in abscess and inflammatory nodule (AN) count at Week 16. Secondary endpoints include achieving HiSCR50 and HiSCR75 at Week 16, as well as absolute changes from baseline in the Dermatology Life Quality Index (DLQI) score, Patient's Global Assessment of Hidradenitis Suppurativa (HS-PtGA) score, and skin pain numerical rating scale (NRS) at Week 16. Additionally, the incidence and severity of treatment-emergent adverse events (TEAEs) will be monitored, along with changes in vital signs, electrocardiogram (ECG) parameters, and clinical laboratory results.

These efficacy parameters will be measured and collected at specific timepoints, with the primary and secondary endpoints being evaluated at Week 16. The tools and instruments used for these assessments include validated scales such as the DLQI, HS-PtGA, and NRS. The data collected will be analyzed to determine the effect of Tibulizumab on the clinical manifestations of hidradenitis suppurativa, providing insights into its potential benefits and safety profile in this patient population.