Study of the Effect of Fostamatinib Upon Cutaneous Inflammation in the Setting of Hidradenitis Suppurativa

  • STATUS
    Recruiting
  • End date
    Oct 27, 2022
  • participants needed
    20
  • sponsor
    Holdsworth House Medical Practice
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Updated on 27 April 2022
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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.

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

Details
Condition Hidradenitis Suppurativa
Treatment fostamatinib
Clinical Study IdentifierNCT05040698
SponsorHoldsworth House Medical Practice
Last Modified on27 April 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Moderate to Severe (Hurley Stage 2 or 3) Hidradenitis Suppurativa as determined by the PI

Exclusion Criteria

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
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