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

Hidradenitis Suppurativa Clinical Trial

Official title:

An Exploratory, Proof-of-Concept Study of the Effect of Fostamatinib Upon Cutaneous Inflammation in the Setting of Hidradenitis Suppurativa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05040698
• Other study ID #: JFR-001
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2021
• Est. completion date: January 27, 2023

Study information

• Verified date: February 2023
• Source: Holdsworth House Medical Practice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 27, 2023
• Est. primary completion date: January 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa
• Inflammation

Intervention

Drug:
• Fostamatinib
Open label Fostamatinib

Locations

Country	Name	City	State
Australia	Holdsworth House Medical Practice	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Holdsworth House Medical Practice	Rigel Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Week 4 evaluation	Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 4 compared to	4 weeks
Primary	Week 12 evaluation	Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 12 compared to Baseline	12 weeks
Secondary	Grade 2/3 Adverse Events	Number of Grade 2/3 Adverse Effects of Fostamatinib over the 12 Week course of treatment.	12 weeks
Secondary	Abscess and Nodule Count Week 4	Changes in Abscess and Nodule count at Week 4 compared to baseline	4 weeks
Secondary	International Hidradenitis Suppurativa Severity Score (IHS4) Week 4	Changes in IHS4 score at Week 4 compared to baseline	4 weeks
Secondary	Abscess and Nodule count week 12	Changes in Abscess and Nodule count at Week 12 compared to baseline	12 weeks
Secondary	International Hidradenitis Suppurativa Severity Score (IHS4) Week 12	Changes in IHS4 score at Week 12 compared to baseline	12 weeks
Secondary	Physician Rated Overall Disease Severity	Changes in physician rated overall disease severity by visual analogue scale (0-10) at week 12 compared to baseline	12 weeks
Secondary	Dermatology Life Quality Index (DLQI)	Changes in the DLQI (0-30) at week 12 compared to baseline	12 weeks