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

• Status: Completed
• Trial end date: 2020-01-27
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether IFX-1 is safe and effective in the treatment of moderate to severe hidradenitis suppurativa.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InflaRx GmbH
• Collaborator: Quintiles, Inc.
• Treatments: Vilobelimab

Criteria

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 (ultraviolet B or psoralen and ultraviolet A)

• History of heart disease or malignancy