Status:
COMPLETED
Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
Lead Sponsor:
InflaRx GmbH
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Hidradenitis Suppurativa (HS)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
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 prese...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2020
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT03487276
Start Date
February 26 2018
End Date
January 27 2020
Last Update
April 8 2021
Active Locations (41)
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1
InflaRX Investigational Site
Birmingham, Alabama, United States, 35233
2
InflaRX Investigational Site
Fort Myers, Florida, United States, 33912
3
InflaRX Investigational Site
Miami, Florida, United States, 33136
4
InflaRX Investigational Site
Sandy Springs, Georgia, United States, 30328