The trial enrolls patients with moderate to severe Hidradenitis Suppurativa (HS). The primary goal of the trial is to evaluate the safety and tolerability of IFX-1 administered over 8 weeks in these patients. In addition the trial aims to characterize the pharmacokinetics and pharmacodynamics of IFX-1 as well as to generate preliminary data on the efficacy of IFX-1 on clinical endpoints (e.g., Hidradenitis Suppurativa Clinical Response (HiSCR), Dermatology Life Quality Index (DLQI), Visual Analog Scale (VAS) for disease, VAS for pain, Hidradenitis Suppurativa - Physician's Global Assessment (HS-PGA), Modified Sartorius Score (mSS)).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
chimeric, monoclonal antibody
ATTIKON University Hospital
Athens, Greece
Number of patients with at least possibly related treatment-emergent adverse events (TEAEs)
Time frame: up to Day 134
Number of patients with detection of anti-drug antibodies (pre-/post-dosing)
Time frame: up to Day 134
Plasma concentration of IFX-1
Time frame: From Day 1 until Day 134
Plasma concentration of C5a
Time frame: Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
Percentage change from baseline in total abscess and nodule (AN) count per time point
Time frame: Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134
Hidradenitis Suppurativa Clinical Response (HiSCR) per time point
Time frame: Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134
Achievement of Hidradenitis Suppurativa - Physician's Global Assessment (HS-PGA) of clear, minimal, or mild among patients with at least 2 grades improvement (reduction) from baseline
Time frame: Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
HS-PGA score per time point
Time frame: Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134
Achievement of at least a 30% reduction and at least a 10 mm reduction in the Visual Analog Scale (VAS) for pain, among patients who had a baseline pain assessment ≥ 30 mm
Time frame: At each visit from Day 1 until Day 134
VAS pain score per time point
Time frame: At each visit from Day 1 until Day 134
Change from baseline in VAS pain score per time point
Time frame: At each visit from Day 1 until Day 134
VAS disease score per time
Time frame: At each visit from Day 1 until Day 134
Change from baseline in VAS disease score per time point
Time frame: At each visit from Day 1 until Day 134
Dermatology Life Quality Index (DLQI) per time point
Time frame: Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
Change from baseline in DLQI per time point
Time frame: Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.