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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05040698
Other study ID # JFR-001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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