Study of the Effect of Fostamatinib Upon Cutaneous Inflammation in the Setting of Hidradenitis Suppurativa
Primary Purpose
Hidradenitis Suppurativa
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Fostamatinib
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring fostamatinib, HS, Tavalisse
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.
Sites / Locations
- Holdsworth House Medical Practice
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open Label Fostamatinib
Arm Description
Open label Fostamatinib 100mg dose adjusted by the Principal Investigator after week 1
Outcomes
Primary Outcome Measures
Week 4 evaluation
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 4 compared to
Week 12 evaluation
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 12 compared to Baseline
Secondary Outcome Measures
Grade 2/3 Adverse Events
Number of Grade 2/3 Adverse Effects of Fostamatinib over the 12 Week course of treatment.
Abscess and Nodule Count Week 4
Changes in Abscess and Nodule count at Week 4 compared to baseline
International Hidradenitis Suppurativa Severity Score (IHS4) Week 4
Changes in IHS4 score at Week 4 compared to baseline
Abscess and Nodule count week 12
Changes in Abscess and Nodule count at Week 12 compared to baseline
International Hidradenitis Suppurativa Severity Score (IHS4) Week 12
Changes in IHS4 score at Week 12 compared to baseline
Physician Rated Overall Disease Severity
Changes in physician rated overall disease severity by visual analogue scale (0-10) at week 12 compared to baseline
Dermatology Life Quality Index (DLQI)
Changes in the DLQI (0-30) at week 12 compared to baseline
Full Information
NCT ID
NCT05040698
First Posted
August 30, 2021
Last Updated
February 27, 2023
Sponsor
Holdsworth House Medical Practice
Collaborators
Rigel Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT05040698
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
January 13, 2023 (Actual)
Study Completion Date
January 27, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Holdsworth House Medical Practice
Collaborators
Rigel Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
fostamatinib, HS, Tavalisse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open Label Fostamatinib
Arm Type
Experimental
Arm Description
Open label Fostamatinib 100mg dose adjusted by the Principal Investigator after week 1
Intervention Type
Drug
Intervention Name(s)
Fostamatinib
Other Intervention Name(s)
Tavalisse, R935788
Intervention Description
Open label Fostamatinib
Primary Outcome Measure Information:
Title
Week 4 evaluation
Description
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 4 compared to
Time Frame
4 weeks
Title
Week 12 evaluation
Description
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 12 compared to Baseline
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Grade 2/3 Adverse Events
Description
Number of Grade 2/3 Adverse Effects of Fostamatinib over the 12 Week course of treatment.
Time Frame
12 weeks
Title
Abscess and Nodule Count Week 4
Description
Changes in Abscess and Nodule count at Week 4 compared to baseline
Time Frame
4 weeks
Title
International Hidradenitis Suppurativa Severity Score (IHS4) Week 4
Description
Changes in IHS4 score at Week 4 compared to baseline
Time Frame
4 weeks
Title
Abscess and Nodule count week 12
Description
Changes in Abscess and Nodule count at Week 12 compared to baseline
Time Frame
12 weeks
Title
International Hidradenitis Suppurativa Severity Score (IHS4) Week 12
Description
Changes in IHS4 score at Week 12 compared to baseline
Time Frame
12 weeks
Title
Physician Rated Overall Disease Severity
Description
Changes in physician rated overall disease severity by visual analogue scale (0-10) at week 12 compared to baseline
Time Frame
12 weeks
Title
Dermatology Life Quality Index (DLQI)
Description
Changes in the DLQI (0-30) at week 12 compared to baseline
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Frew, MBBS
Organizational Affiliation
Holdsworth House Medical Practice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holdsworth House Medical Practice
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of the Effect of Fostamatinib Upon Cutaneous Inflammation in the Setting of Hidradenitis Suppurativa
We'll reach out to this number within 24 hrs