NCT05040698

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 10, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

1.3 years

First QC Date

August 30, 2021

Last Update Submit

February 27, 2023

Conditions

Hidradenitis Suppurativa

Keywords

fostamatinibHSTavalisse

Outcome Measures

Primary Outcomes (2)

  • Week 4 evaluation

    Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 4 compared to

    4 weeks

  • 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 Outcomes (7)

  • Grade 2/3 Adverse Events

    12 weeks

  • Abscess and Nodule Count Week 4

    4 weeks

  • International Hidradenitis Suppurativa Severity Score (IHS4) Week 4

    4 weeks

  • Abscess and Nodule count week 12

    12 weeks

  • International Hidradenitis Suppurativa Severity Score (IHS4) Week 12

    12 weeks

  • +2 more secondary outcomes

Study Arms (1)

Open Label Fostamatinib

EXPERIMENTAL

Open label Fostamatinib 100mg dose adjusted by the Principal Investigator after week 1

Drug: Fostamatinib

Interventions

FostamatinibDRUG

Open label Fostamatinib

Also known as: Tavalisse, R935788
Open Label Fostamatinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate to Severe (Hurley Stage 2 or 3) Hidradenitis Suppurativa as determined by the PI

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

fostamatinib

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland Diseases

Study Officials

  • John Frew, MBBS

    Holdsworth House Medical Practice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 30, 2021

First Posted

September 10, 2021

Study Start

October 1, 2021

Primary Completion

January 13, 2023

Study Completion

January 27, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)