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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05040698




Registration number
NCT05040698
Ethics application status
Date submitted
30/08/2021
Date registered
10/09/2021
Date last updated
1/03/2023

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
Timepoint [1] 0 0
4 weeks
Primary outcome [2] 0 0
Week 12 evaluation
Timepoint [2] 0 0
12 weeks
Secondary outcome [1] 0 0
Grade 2/3 Adverse Events
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Abscess and Nodule Count Week 4
Timepoint [2] 0 0
4 weeks
Secondary outcome [3] 0 0
International Hidradenitis Suppurativa Severity Score (IHS4) Week 4
Timepoint [3] 0 0
4 weeks
Secondary outcome [4] 0 0
Abscess and Nodule count week 12
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
International Hidradenitis Suppurativa Severity Score (IHS4) Week 12
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Physician Rated Overall Disease Severity
Timepoint [6] 0 0
12 weeks
Secondary outcome [7] 0 0
Dermatology Life Quality Index (DLQI)
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/01/2023
Sample size
Target
Accrual to date
Final
20
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/ct2/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05040698