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

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ClinicalTrials.gov Identifier: NCT05040698
Recruitment Status : Not yet recruiting
First Posted : September 10, 2021
Last Update Posted : September 10, 2021
Sponsor:
Collaborator:
Rigel Pharmaceuticals
Information provided by (Responsible Party):
John Frew, Holdsworth House Medical Practice

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.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Drug: Fostamatinib Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory, Proof-of-Concept Study of the Effect of Fostamatinib Upon Cutaneous Inflammation in the Setting of Hidradenitis Suppurativa
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open Label Fostamatinib
Open label Fostamatinib 100mg dose adjusted by the Principal Investigator after week 1
Drug: Fostamatinib
Open label Fostamatinib
Other Names:
  • Tavalisse
  • R935788




Primary Outcome Measures :
  1. Week 4 evaluation [ Time Frame: 4 weeks ]
    Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 4 compared to

  2. Week 12 evaluation [ Time Frame: 12 weeks ]
    Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 12 compared to Baseline


Secondary Outcome Measures :
  1. Grade 2/3 Adverse Events [ Time Frame: 12 weeks ]
    Number of Grade 2/3 Adverse Effects of Fostamatinib over the 12 Week course of treatment.

  2. Abscess and Nodule Count Week 4 [ Time Frame: 4 weeks ]
    Changes in Abscess and Nodule count at Week 4 compared to baseline

  3. International Hidradenitis Suppurativa Severity Score (IHS4) Week 4 [ Time Frame: 4 weeks ]
    Changes in IHS4 score at Week 4 compared to baseline

  4. Abscess and Nodule count week 12 [ Time Frame: 12 weeks ]
    Changes in Abscess and Nodule count at Week 12 compared to baseline

  5. International Hidradenitis Suppurativa Severity Score (IHS4) Week 12 [ Time Frame: 12 weeks ]
    Changes in IHS4 score at Week 12 compared to baseline

  6. Physician Rated Overall Disease Severity [ Time Frame: 12 weeks ]
    Changes in physician rated overall disease severity by visual analogue scale (0-10) at week 12 compared to baseline

  7. Dermatology Life Quality Index (DLQI) [ Time Frame: 12 weeks ]
    Changes in the DLQI (0-30) at week 12 compared to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05040698


Contacts
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Contact: Trina Vincent, R.N. +61280381044 trina.vincent@holdsworthhouse.com.au
Contact: John Frew, MBBS 02 93317228 john.frew@holdsworthhouse.com.au

Locations
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Australia, New South Wales
Holdsworth House Medical Practice
Sydney, New South Wales, Australia, 2010
Contact: Trina Vincent, R.N.    0280381044    trina.vincent@holdsworthhouse.com.au   
Contact: Georgia Rudevics    02 80381044    georgia.rudevics@holdsworthhouse.com.au   
Principal Investigator: John Frew, MBBS         
Sponsors and Collaborators
Holdsworth House Medical Practice
Rigel Pharmaceuticals
Investigators
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Principal Investigator: John Frew, MBBS Holdsworth House Medical Practice
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Responsible Party: John Frew, Principal Investigator, Holdsworth House Medical Practice
ClinicalTrials.gov Identifier: NCT05040698    
Other Study ID Numbers: JFR-001
First Posted: September 10, 2021    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by John Frew, Holdsworth House Medical Practice:
fostamatinib
HS
Tavalisse
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Inflammation
Pathologic Processes
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration