A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP)
- Conditions
- Primary Immune ThrombocytopeniaMedDRA version: 20.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2019-000883-40-CZ
- Lead Sponsor
- CB Biopharma SR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 210
-Study participant completed TP0003 [NCT04200456] or TP0006 [NCT04224688] until Visit 28 (Week 25) and, in the opinion of the investigator and sponsor, 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
-If taking allowed concomitant medications, study participant must have been on stable doses
- 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 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 138
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 72
-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 had any relevant resolved IMP-related SAE or severe IMP-related TEAE experienced during TP0003 or TP0006 that was not discussed and approved as acceptable for enrollment into open-label extension (OLE) study by Medical Monitor or designee
-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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assess the long-term safety and tolerability of repeated treatment with rozanolixizumab (Maintenance Treatment Arm only)<br>;Secondary Objective: -Assess the long-term clinical efficacy of repeated treatment with rozanolixizumab (Maintenance Treatment Arm only)<br>-Assess effect of rozanolixizumab on health-related quality of life (HRQoL)<br>-Assess the pharmacodynamic (PD) effect of rozanolixizumab (Maintenance Treatment Arm only)<br>-Assess the effect of rozanolixizumab on patient-reported outcomes (PROs)<br>-Assess the reduction in use of steroids in study participants receiving rozanolixizumab<br>;Primary end point(s): 1. Occurrence of treatment-emergent adverse events (TEAEs)<br>2. Occurrence of TEAEs leading to withdrawal of rozanolixizumab<br>;Timepoint(s) of evaluation of this end point: 1. and 2. From Baseline to end of Safety Follow-Up Period (up to Week 61)<br>
- Secondary Outcome Measures
Name Time Method