Yükleniyor... / Loading...
Study of the Effect of Fostamatinib Upon Cutaneous Inflammation in the Setting of Hidradenitis Suppurativa
Bu çalışma, orta ila şiddetli hidradenitis suppurativa hastalarında Fostamatinib ilacının deri iltihabı (cutaneous inflammation) üzerindeki etkisini incelemiştir. Çalışmaya, doktor tarafından orta ila şiddetli (Hurley Evre 2 veya 3) hidradenitis suppurativa tanısı konulan hastalar alınmıştır. Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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.