NCT05040698

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

An Exploratory, Proof-of-Concept Study of the Effect of Fostamatinib Upon Cutaneous Inflammation in the Setting of Hidradenitis Suppurativa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Holdsworth House Medical Practice · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	Fostamatinib	Open label Fostamatinib

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-01-13
• Completion: 2023-01-27
• First posted: 2021-09-10
• Last updated: 2023-03-01

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study