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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT05040698




Registration number
NCT05040698
Ethics application status
Date submitted
30/08/2021
Date registered
10/09/2021
Date last updated
10/09/2021

Titles & IDs
Public title
Study of the Effect of Fostamatinib Upon Cutaneous Inflammation in the Setting of Hidradenitis Suppurativa
Scientific title
An Exploratory, Proof-of-Concept Study of the Effect of Fostamatinib Upon Cutaneous Inflammation in the Setting of Hidradenitis Suppurativa
Secondary ID [1] 0 0
JFR-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fostamatinib

Experimental: Open Label Fostamatinib - Open label Fostamatinib 100mg dose adjusted by the Principal Investigator after week 1


Treatment: Drugs: Fostamatinib
Open label Fostamatinib

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Week 4 evaluation - Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 4 compared to
Timepoint [1] 0 0
4 weeks
Primary outcome [2] 0 0
Week 12 evaluation - Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 12 compared to Baseline
Timepoint [2] 0 0
12 weeks
Secondary outcome [1] 0 0
Grade 2/3 Adverse Events - Number of Grade 2/3 Adverse Effects of Fostamatinib over the 12 Week course of treatment.
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Abscess and Nodule Count Week 4 - Changes in Abscess and Nodule count at Week 4 compared to baseline
Timepoint [2] 0 0
4 weeks
Secondary outcome [3] 0 0
International Hidradenitis Suppurativa Severity Score (IHS4) Week 4 - Changes in IHS4 score at Week 4 compared to baseline
Timepoint [3] 0 0
4 weeks
Secondary outcome [4] 0 0
Abscess and Nodule count week 12 - Changes in Abscess and Nodule count at Week 12 compared to baseline
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
International Hidradenitis Suppurativa Severity Score (IHS4) Week 12 - Changes in IHS4 score at Week 12 compared to baseline
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Physician Rated Overall Disease Severity - Changes in physician rated overall disease severity by visual analogue scale (0-10) at week 12 compared to baseline
Timepoint [6] 0 0
12 weeks
Secondary outcome [7] 0 0
Dermatology Life Quality Index (DLQI) - Changes in the DLQI (0-30) at week 12 compared to baseline
Timepoint [7] 0 0
12 weeks

Eligibility
Key inclusion criteria
- Moderate to Severe (Hurley Stage 2 or 3) Hidradenitis Suppurativa as determined by the
PI
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Holdsworth House Medical Practice
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Rigel Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT05040698
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Frew, MBBS
Address 0 0
Holdsworth House Medical Practice
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trina Vincent, R.N.
Address 0 0
Country 0 0
Phone 0 0
+61280381044
Fax 0 0
Email 0 0
trina.vincent@holdsworthhouse.com.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT05040698