Clinical trial NCT05040698: Study of the Effect of Fostamatinib Upon Cutaneous Inflammation in the Setting of Hidradenitis Suppurativa
Official title: An Exploratory, Proof-of-Concept Study of the Effect of Fostamatinib Upon Cutaneous Inflammation in the Setting of Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Keywords: fostamatinib
HS
Tavalisse
Lead sponsor: Holdsworth House Medical Practice
Sponsor class: OTHER
Collaborators: name: Rigel Pharmaceuticals
First posted: 2021-09-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Week 4 evaluation
timeFrame: 4 weeks
measure: Week 12 evaluation
timeFrame: 12 weeks
Secondary outcomes:
measure: Grade 2/3 Adverse Events
timeFrame: 12 weeks
measure: Abscess and Nodule Count Week 4
timeFrame: 4 weeks
measure: International Hidradenitis Suppurativa Severity Score (IHS4) Week 4
timeFrame: 4 weeks
measure: Abscess and Nodule count week 12
timeFrame: 12 weeks
measure: International Hidradenitis Suppurativa Severity Score (IHS4) Week 12
timeFrame: 12 weeks
measure: Physician Rated Overall Disease Severity
timeFrame: 12 weeks
measure: Dermatology Life Quality Index (DLQI)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
Study officials:
affiliation: Holdsworth House Medical Practice
name: John Frew, MBBS
role: PRINCIPAL_INVESTIGATOR
References: