The study duration for an individual subject includes screening (14 days), the treatment period (28 days) and the observational follow-up period of 28 days, in total 70 days ± 6 days. All subjects will receive IMP for 28 days followed by one End of Study (EOS) visit, 4 weeks after EOT visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
CSU lower dose treatment
CSU high dose treatment
CSU non responders IgE - high dose treatment
Frequency, severity, and relatedness of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Frequency, severity, and relatedness of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) using MedDRA classification.
Time frame: Through study completion, an average of 10 weeks
Maximum Plasma Concentration [Cmax]
Plasma PK parameters of INF904
Time frame: Through study completion, an average of 10 weeks
Minimum Plasma Concentration [Cmin]
Plasma PK parameters of INF904
Time frame: Through study completion, an average of 10 weeks
Time of occurrence of maximum plasma concentration [tmax]
Plasma PK parameters of INF904
Time frame: Through study completion, an average of 10 weeks
Systemic exposure, defined as the Area Under the Curve [AUC0-24]
Plasma PK parameters of INF904
Time frame: Through study completion, an average of 10 weeks
Systemic exposure, defined as the Area Under the Curve [AUClast]
Plasma PK parameters of INF904
Time frame: Through study completion, an average of 10 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
HS low dose treatment
HS medium dose treatment
HS high dose treatment
First OC Dermatology Research Inc.
Fountain Valley, California, United States
Ziaderm Research LLC
North Miami Beach, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Kentucky Advanced Medical Research LLC
Murray, Kentucky, United States
MediSearch LLC
Saint Joseph, Missouri, United States
Forest Hills Dermatology Group
Kew Gardens, New York, United States
Wright State Physicians
Fairborn, Ohio, United States
Progressive Clinical Research, PA
Texas City, Texas, United States
Medical Center Medconsult, Pleven OOD
Lovech, Bulgaria
...and 19 more locations