Study of the Effect of Fostamatinib Upon Cutaneous Inflammation in the Setting of Hidradenitis Suppurativa
- Registration Number
- NCT05040698
- Lead Sponsor
- Holdsworth House Medical Practice
- Brief Summary
A 16 week exploratory, Proof of Concept study to evaluate the effect of Fostamatinib (12 weeks of treatment) upon cutaneous inflammation in Hidradenitis Suppurativa.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Moderate to Severe (Hurley Stage 2 or 3) Hidradenitis Suppurativa as determined by the PI
- Uncontrolled hypertension (systolic blood pressure [BP] ≥135 mmHg and/or diastolic BP ≥85 mmHg), unstable angina, congestive heart failure of New York Heart Association classification III or IV, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia) at screening.
- History of myocardial infarction within 3 months prior to screening.
- Shock or hypotension requiring vasoactive peptides, such as dopamine, norepinephrine, epinephrine, or dobutamine at screening or at randomization.
- Renal function impairment with creatinine clearance <30 mL/min at screening (estimated glomerular filtration rate will be calculated using the modification of diet in renal disease equation).
- Liver function impairment with aspartate aminotransferase/alanine aminotransferase >=3x the upper limit of normal or bilirubin >2X the upper limit of normal at screening.
- Neutrophil count <1000/µL at screening.
- History of an allergic reaction or hypersensitivity to the study treatment or any component of the study treatment formulation.
- Has documented HIV infection or documented, active hepatitis B or hepatitis C infection.
- Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
- Individuals with concurrent use of systemic antibiotics/ oral retinoids/ systemic immunosuppressants (those with prior use of these medications must have conducted a washout period of 4 weeks or 5 half-lives of the drug, whichever is longer).
- Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open Label Fostamatinib Fostamatinib Open label Fostamatinib 100mg dose adjusted by the Principal Investigator after week 1
- Primary Outcome Measures
Name Time Method Week 4 evaluation 4 weeks Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 4 compared to
Week 12 evaluation 12 weeks Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 12 compared to Baseline
- Secondary Outcome Measures
Name Time Method Abscess and Nodule Count Week 4 4 weeks Changes in Abscess and Nodule count at Week 4 compared to baseline
Physician Rated Overall Disease Severity 12 weeks Changes in physician rated overall disease severity by visual analogue scale (0-10) at week 12 compared to baseline
International Hidradenitis Suppurativa Severity Score (IHS4) Week 12 12 weeks Changes in IHS4 score at Week 12 compared to baseline
International Hidradenitis Suppurativa Severity Score (IHS4) Week 4 4 weeks Changes in IHS4 score at Week 4 compared to baseline
Grade 2/3 Adverse Events 12 weeks Number of Grade 2/3 Adverse Effects of Fostamatinib over the 12 Week course of treatment.
Abscess and Nodule count week 12 12 weeks Changes in Abscess and Nodule count at Week 12 compared to baseline
Dermatology Life Quality Index (DLQI) 12 weeks Changes in the DLQI (0-30) at week 12 compared to baseline
Trial Locations
- Locations (1)
Holdsworth House Medical Practice
🇦🇺Sydney, New South Wales, Australia