Phase 0 Study of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa to identify biomarkers of disease activity and clinical response.
Phase 0, Open Label study of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa. Consisting of n=10 patients receiving 210mg subcutaneously every 2 weeks for 24 weeks. Patients will be followed for a period of 36 weeks (12 weeks after last dose of Brodalumab) to assess for safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
10
interleukin 17 receptor A antagonist
Rockefeller Unviersity
New York, New York, United States
Biomarkers at Week 12
Primary Outcomes would be the change in lesional tissue levels of IL-17A, IL-17C, IL-17F and IL-23 measured in pg/mL measured in pg/mL
Time frame: Week 12 compared with baseline.
Biomarkers at Week 24
Primary Outcomes would be the change in lesional tissue levels of IL-17A, IL-17C, IL-17F and IL-23 measured in pg/mL measured in pg/mL
Time frame: Week 24 compared with baseline.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Grade 2/3 adverse events during the study
Time frame: Week 0 to Week 24
Clinical Response at Week 12 (as measured by HiSCR)
Clinical Response compared to baseline as assessed by the HiSCR (Hidradenitis Suppurativa Clinical Response) Defined as a greater than or equal to 50% reduction in inflammatory lesion count (abscesses plus inflammatory nodules), and no increase in abscesses or draining fistulas at Week 12 when compared with baseline
Time frame: Week 12 compared with Baseline
Clinical Response at Week 12 (as measured by modified Sartorius Score)
Clinical Response compared to baseline as assessed by the modified Sartorius Score as follows: Sum of separate scoring for each affected area using the data recorded as follows: a) 3 points per anatomical region involved; b) 6 points for each fistula and 1 point for each nodule or abscess; c) 1 point when the longest distance between two relevant lesions in each affected area is \<5 cm; 3 points when it is 5-10 cm; and 9 points when it is \>10 cm; d) 9 points when there is no clear separation of lesions from adjacent normal skin and 0 points when there is.
Time frame: Week 12 compared with Baseline
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Clinical Response at Week 12 (as measured by IHS4)
Clinical Response compared to baseline as assessed by IHS4 (International Hidradenitis Suppurativa Severity Score) using the scoring system as follows: Total= (Number of nodules x1) + (Number of abscesses x2) + (Number of draining sinuses/fistulae x4)
Time frame: Week 12 compared with Baseline
Clinical Response at Week 24 (as measured by HiSCR)
Clinical Response compared to baseline as assessed by the HiSCR (Hidradenitis Suppurativa Clinical Response) Defined as a greater than or equal to 50% reduction in inflammatory lesion count (abscesses plus inflammatory nodules), and no increase in abscesses or draining fistulas at Week 24 when compared with baseline
Time frame: Week 24 compared with Baseline
Clinical Response at Week 24 (as measured by modified Sartorius Score)
Clinical Response compared to baseline as assessed by the modified Sartorius Score as follows: Sum of separate scoring for each affected area using the data recorded as follows: a) 3 points per anatomical region involved; b) 6 points for each fistula and 1 point for each nodule or abscess; c) 1 point when the longest distance between two relevant lesions in each affected area is \<5 cm; 3 points when it is 5-10 cm; and 9 points when it is \>10 cm; d) 9 points when there is no clear separation of lesions from adjacent normal skin and 0 points when there is.
Time frame: Week 24 compared with Baseline
Clinical Response at Week 24 (as measured by IHS4)
Clinical Response compared to baseline as assessed by IHS4 (International Hidradenitis Suppurativa Severity Score) using the scoring system as follows: Total= (Number of nodules x1) + (Number of abscesses x2) + (Number of draining sinuses/fistulae x4)
Time frame: Week 24 compared with Baseline