The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
* Intervention Type: Biological/Vaccine * Pharmaceutical Form: Powder for solution for infusion * Concentration: 100 mg/ml - Route of Administration: Subcutaneous infusion
Tp0001 1101
Adelaide, Australia
Tp0001 1302
Pleven, Bulgaria
Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (TEAE) During the Study
TEAEs were defined as Adverse Events starting after the time of first Investigational Medicinal Product (IMP) administration up to and including 8 weeks after the final dose.
Time frame: From Visit 2 (Week 1) until End of Study Visit or Early Termination (up to 12 weeks after the first investigational medicinal product (IMP) administration)
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Tp0001 1301
Sofia, Bulgaria
Tp0001 203
Olomouc, Czechia
Tp0001 201
Prague, Czechia
Tp0001 1201
Tbilisi, Georgia
Tp0001 401
Berlin, Germany
Tp0001 403
Düsseldorf, Germany
Tp0001 404
München, Germany
Tp0001 502
Florence, Italy
...and 19 more locations