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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa (HS)

In brief

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

Key facts

Study ID

NCT03487276

Run by

InflaRx GmbH

People needed

179

Starts

2018-02-26

Expected to finish

2020-01-27

Last updated by the study team

2021-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• InflaRX Investigational Site — Birmingham, Alabama, United States
• InflaRX Investigational Site — Fort Myers, Florida, United States
• InflaRX Investigational Site — Miami, Florida, United States
• InflaRX Investigational Site — Sandy Springs, Georgia, United States
• InflaRX Investigational Site — Dearborn, Michigan, United States
• InflaRX Investigational Site — Columbia, Missouri, United States
• InflaRx Investigational Site — Saint Joseph, Missouri, United States
• InflaRX Investigational Site — St Louis, Missouri, United States
• InflaRX Investigational Site — St Louis, Missouri, United States
• InflaRX Investigational Site — Chapel Hill, North Carolina, United States
• InflaRX Investigational Site — Cincinnati, Ohio, United States
• InflaRX Investigational Site — Hershey, Pennsylvania, United States
• InflaRx Investigational Site — Goodlettsville, Tennessee, United States
• InflaRX Investigational Site — Sofia, Bulgaria
• InflaRX Investigational Site — Sofia, Bulgaria
• InflaRX Investigational Site — Stara Zagora, Bulgaria
• InflaRX Investigational Site — St. John's, Newfoundland and Labrador, Canada
• InflaRX Investigational Site — Peterborough, Ontario, Canada
• InflaRX Investigational Site — Richmond Hill, Ontario, Canada
• InflaRX Investigational Site — Copenhagen, Denmark
• InflaRX Investigational Site — Roskilde, Denmark
• InflaRX Investigational Site — Nice, Alpes Maritimes, France
• InflaRX Investigational Site — Bordeaux, Gironde, France
• InflaRX Investigational Site — Toulouse, Haute Garonne, France
• InflaRX Investigational Site — Antony, Hauts De Seine, France

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.