A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of NAV-240 in Adults with Moderate-to-Severe Hidradenitis Suppurativa

The primary objective is to evaluate the efficacy of NAV-240 compared to placebo in adults with moderate-to-severe hidradenitis suppurativa. 5

Secondary objectives include:

• Assessment of clinical signs and symptoms associated with the disease.
• Evaluation of the safety and tolerability of NAV-240. 4

This clinical trial involves 59 participants diagnosed with hidradenitis suppurativa. The study population consists of both male and female patients between the ages of 18 and 70. To be eligible, subjects must have a documented history of the disease for a minimum of 6 months. Inclusion requires the presence of at least 5 abscesses and nodules, alongside inflamed skin lesions located in at least 2 distinct anatomical regions, with at least one area demonstrating Hurley Stage II or Hurley Stage III severity. Additionally, participants must have demonstrated an inadequate response to at least one course of antibiotics.

This Phase 2a, multicenter, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy of NAV-240 compared to sodium chloride in adult participants diagnosed with hidradenitis suppurativa. The methodology involves the administration of either the investigational product or a placebo via intravenous infusion. The research process begins with a screening visit to assess eligibility based on specific clinical criteria, including a minimum disease duration of 6 months and a classification of Hurley Stage II or Hurley Stage III. Following screening, participants will undergo study visits to monitor clinical responses, including the Hidradenitis Suppurativa Clinical Response (HiSCR) 75, which is the primary endpoint measured at Week 16. Secondary assessments include the numeric rating scale (NRS) for pain, the Dermatology Life Quality Index (DLQI), and the International Hidradenitis Suppurativa Severity Score System (IHS4). The study includes follow-up evaluations to monitor for disease flares and treatment-related adverse effects. The trial concludes with an end-of-study visit. The total duration of participant involvement is determined by the clinical monitoring schedule through the primary endpoint assessment at Week 16.

The experimental treatment consists of NAV-240, provided as a concentrate for solution for infusion. This substance is administered via intravenous use.

The control group receives a placebo consisting of sodium chloride 0.9% in a solution for infusion. This administration is performed via the intravenous route.

The efficacy of NAV-240 in participants with hidradenitis suppurativa will be evaluated using several predefined endpoints. The primary endpoint is the percentage of participants achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 16. This is defined as a minimum 75% reduction in the abscess and inflammatory nodule (AN) count from baseline, with no increase in the number of abscesses or draining tunnels.

Secondary efficacy parameters assessed at Week 16 include:

• The percentage of participants achieving a skin pain numeric rating scale (NRS) 30 response, characterized by at least a 30% and 2-point reduction in pain scores from baseline in individuals with initial NRS scores of 3 or higher.
• The percentage of participants achieving HiSCR 50.
• The percentage of participants achieving a meaningful improvement in quality of life, defined as a Dermatology Life Quality Index (DLQI) reduction of 4 or more points among those with initial DLQI scores of 4 or higher.
• The percentage of participants experiencing a HS flare, defined as an increase in AN count of at least 25% with an absolute increase of 2 or more compared to baseline.
• Changes in disease severity measured by the International Hidradenitis Suppurativa Severity Score System (IHS4) from baseline to Week 16.
• Changes in the AN count and the number of draining tunnels from baseline to Week 16.