Overview

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

Status:
Not yet recruiting
Trial end date:
2022-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Holdsworth House Medical Practice
Collaborator:
Rigel Pharmaceuticals
Criteria
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.