Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)

The primary efficacy endpoint of the percentage of patients with HiSCR at Week 16 was analyzed using the multiple comparisons procedure-modelling (MCP-Mod) procedure. The definition for response to treatment based on HiSCR relative to Baseline was: at least 50% reduction in abscesses and inflammatory nodule (AN) count (over all anatomical regions) with no increase in number of abscesses and in number of draining fistulas.

Endpoint of the percentage of patients with HiSCR at Week 12 was analyzed in the same way as the primary endpoint using the MCP-Mod procedure and the same definition of response.

The number of patients with flares analyzed in terms of ≥ 25% increase in abscess and inflammatory nodule (AN) count among patients with a minimum increase of 2 in AN count compared to Day 1 was analyzed by descriptive statistics by time point.

The absolute change from Day 1 will be analyzed by descriptive statistics by time point. The mSS is a summation of HS lesions based on a number of factors including anatomical region, number and type of lesions, distance between relevant lesions and lesions clearly separated by normal skin in each region measured as HS clinical parameters. The scale title for mSS is points. The mSS has a minimum value of 0 and no upper limit. The higher the score the more severe is the disease/worse is the outcome.

The absolute changes from baseline were analyzed by descriptive statistics by time point. The Numeric Rating Scale (NRS) was used to assess the worst skin pain due to HS. The scale title for the NRS is points. Ratings for this item range from a minimum of 0 points (no skin pain) to a maximum of 10 points (skin pain as bad as you can imagine). The higher the score the more severe the disease/worse is the outcome.

This is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10) that best reflects the intensity of their pain. The scale title for the NRS is points. The minimum score is 0 points (No skin pain), and the maximum score is 10 points (Skin pain as bad as you can imagine). The higher the score the more severe is the disease/worse is the outcome. The number of patients with at least 30% reduction and at least 1 point reduction from Day 1 in Patients Global Assessment of Skin Pain are displayed. The analysis is based on the worst skin pain the patients reported at the respective visits.

This is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10) that best reflects the intensity of their pain. The scale title for NRS is points. The minimum score is 0 points (No skin pain), and the maximum score is 10 points (Skin pain as bad as you can imagine). The higher the score the more severe is the disease/worse is the outcome. The number of patients with at least 50% reduction and at least 1 point reduction from Day 1 in Patients Global Assessment of Skin Pain are displayed. The analysis is based on the worst skin pain the patients reported at the respective visits.

The changes from Day 1 will be analyzed by descriptive statistics by time point. A score is documented for each of the 10 DLQI items, ranging from 0 to 3 for each item. The scale title for DLQI is points. The total score is the sum of the responses to all 10 DLQI items, ranging from the minimum of 0 points to the maximum of 30 points. A higher score corresponds to worse health related quality of life/outcome.

The number of patients with any treatment emergent adverse event (adverse events that started after first infusion of IMP) was analyzed by time point.