Primary immune thrombocytopenia
Conditions
Interventions
Study participants receive rozanolixizumab by subcutaneous infusion during the Treatment Period.
Study participants will receive fixed-unit doses of rozanolixizumab across body weight tiers.
Sponsors
Sugihara Kazuhiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Study participant completed TP0003 [NCT04200456] or TP0006 [NCT04224688] until Visit 27 (Week 25) and, in the opinion of the investigator, has been compliant with the TP0003 or TP0006 study assessments -The study participant is considered reliable and capable of adhering to the protocol, visit schedule, or medication intake according to the judgment of the investigator - Study participants may be male or female: a) A male participant must agree to use contraception during the Treatment Period and for at least 3 months after the final dose of study treatment and refrain from donating sperm during this period b) A female participant is eligible to participate if she is not pregnant as confirmed by a negative urine pregnancy test or not planning to get pregnant during the participation in the study, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 3 months after the final dose of study treatment
Exclusion criteria
Exclusion criteria: -Study participant has any ongoing investigational medicinal product (IMP)-related serious adverse event (SAE) or ongoing severe IMP-related treatment-emergent adverse event (TEAE) experienced during TP0003 or TP0006 -Study participant has, at last available assessment of TP0003 or TP0006, 3.0x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Occurrence of treatment-emergent adverse events (TEAEs) - Occurrence of TEAEs leading to withdrawal of rozanolixizumab (ie, study discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| Stable Clinically Meaningful Response without rescue therapy at equal and over 70% of the visits over the planned 52-week Treatment Period starting at Week 4 - Change from Baseline to Week 53 including all intermediate timepoints for ITP Patient Assessment Questionnaire (ITP-PAQ) Symptoms domain score - Area under the curve (AUC) of the oral steroid dose over time - Change in dose and/or frequency of concomitant ITP medications (excluding corticosteroids) over time | — |
Countries
Austria, Belgium, Bulgaria, Canada, China, Croatia, Czechia, Denmark, France, Georgia, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Poland, Republic of Moldova, Romania, Russian Federation, Serbia, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Science & Operation
UCB Japan Co., Ltd.
Outcome results
None listed