A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic Mastocytosis

Date Added
January 11th, 2023
PRO Number
Pro00123694
Researcher
Kelli Williams

List of Studies


Keywords
Blood Disorders, Cancer/Other, Immune System
Summary

The purpose of this study is determine the optimal dose, efficacy and safety of an investigational drug (a new drug not yet approved by the U.S. Food and Drug Administration) in adults with Advanced Systemic Mastocytosis. The investigational drug is known as CGT9486 and will be taken daily orally. Participation in the study is expected to be approximately 6 years.

Institution
MUSC
Recruitment Contact
Natalie Naylon
8437925824
naylon@musc.edu

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Depemokimab in Adults with Hypereosinophilic Syndrome (HES)

Date Added
May 3rd, 2022
PRO Number
Pro00119532
Researcher
Kelli Williams

List of Studies


Keywords
Blood Disorders, Rare Diseases
Summary

The purpose of this study is to see if taking depemokimab is safe and effective in treating Hypereosinophilic syndrome (HES) in adults (≥18 years) with uncontrolled HES receiving standard of care (SoC) therapy. The study will last approximately 52 weeks and is a placebo-controlled, double blind, multicentre study.

Institution
MUSC
Recruitment Contact
Natalie Naylon
843-792-5824
naylon@musc.edu

A 52-week, open-label, single arm study to investigate the efficacy and safety of mepolizumab SC in participants aged 6 to 17 years with hypereosinophilic syndrome.

Date Added
September 8th, 2021
PRO Number
Pro00113422
Researcher
Kelli Williams

List of Studies


Keywords
Adolescents, Allergy, Pediatrics
Summary

The purpose of this study is to see if taking mepolizumab is safe and effective in treating Hypereosinophilic syndrome (HES) in children and adolescent patients ages 6 to 17 years who are receiving standard of care (SoC) therapy. Mepolizumab is administered through a subcutaneous injection (shot). Participation in the study will last for about 64 weeks approximately (1 year and 3 months).

Institution
MUSC
Recruitment Contact
Natalie Naylon
843-792-5824
naylon@musc.edu



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