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

Hidradenitis suppurativa (HS) is a chronic devastating skin disorder affecting areas rich in
apocrine glands. HS is diagnosed by its clinical features and its chronicity. It is
recognized by the presence of recurrent, painful, deep-seated, rounded nodules usually ending
in abscesses and sinus tracts with suppuration and hypertrophic scarring. As complement C5a
is involved in the underlying acute inflammatory responses, this study is set up based on the
hypothesis that IFX-1 might be able to block C5a induced pro-inflammatory effects such as
neutrophil activation and cytokine generation, potentially contributing to the local skin
inflammation and tissue damage.

Inclusion Criteria:

- Male or female, ≥ 18 years of age

- Written informed consent obtained from subject

- Diagnosis of HS for at least 1 year

- Moderate or severe HS, as indicated by HS lesions in at least 2 distinct areas, 1 of
which must be at least Hurley Stage II or Stage III

- Inadequate response to at least 3 months of oral antibiotics, or intolerance to
antibiotics

- Total abscess and inflammatory nodule (AN) count of ≥ 3

Exclusion Criteria:

- Prior treatment with adalimumab or another biologic product during the 24 weeks before
Screening

- Subjects on permitted oral antibiotic treatment for HS (doxycycline or minocycline
only) who have not been on a stable dose during the 28 days before Screening

- Subject received systemic non-biologic therapy for HS with potential therapeutic
impact for HS during the 28 days before Screening (other than permitted oral
antibiotics)

- Prior treatment with any of the following medications during the 28 days before
Screening:

- Any other systemic therapy for HS

- Any iv anti-infective therapy

- Phototherapy (ultra-violet B [UVB] or psoralen and ultra-violet A [UVA])

- History of heart disease or malignancy