A 16 week exploratory, Proof of Concept study to evaluate the effect of Fostamatinib (12 weeks of treatment) upon cutaneous inflammation in Hidradenitis Suppurativa.
Sample size: 20 patients Study duration: 16 weeks Primary Endpoints: Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 4 compared to Baseline. Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 12 compared to Baseline. Secondary Endpoints: Safety and Tolerability (Grade 2/3 Adverse Effects); Changes in Disease Activity (Measures by AN count and IHS4 scoring). Study procedures Clinical Examination, Patient Questionnaires, Skin Biopsy, Blood Draw, medical photography
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Open label Fostamatinib
Holdsworth House Medical Practice
Sydney, New South Wales, Australia
Week 4 evaluation
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 4 compared to
Time frame: 4 weeks
Week 12 evaluation
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 12 compared to Baseline
Time frame: 12 weeks
Grade 2/3 Adverse Events
Number of Grade 2/3 Adverse Effects of Fostamatinib over the 12 Week course of treatment.
Time frame: 12 weeks
Abscess and Nodule Count Week 4
Changes in Abscess and Nodule count at Week 4 compared to baseline
Time frame: 4 weeks
International Hidradenitis Suppurativa Severity Score (IHS4) Week 4
Changes in IHS4 score at Week 4 compared to baseline
Time frame: 4 weeks
Abscess and Nodule count week 12
Changes in Abscess and Nodule count at Week 12 compared to baseline
Time frame: 12 weeks
International Hidradenitis Suppurativa Severity Score (IHS4) Week 12
Changes in IHS4 score at Week 12 compared to baseline
Time frame: 12 weeks
Physician Rated Overall Disease Severity
Changes in physician rated overall disease severity by visual analogue scale (0-10) at week 12 compared to baseline
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Time frame: 12 weeks
Dermatology Life Quality Index (DLQI)
Changes in the DLQI (0-30) at week 12 compared to baseline
Time frame: 12 weeks