Clinical Trials List
2021-04-01 - 2022-09-30
Phase III
Not yet recruiting8
ICD-10D69.3
Immune thrombocytopenic purpura
An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
-
Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
-
Sponsor
UCB Biopharma SRL
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chia-Jen Liu Division of Hematology & Oncology
- Liang-Tsai Hsiao Division of Hematology & Oncology
- Hao-Yuan Wang Division of Hematology & Oncology
- Yao-Chung Liu Division of Hematology & Oncology
- Po-Shen Ko Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Tung-Liang Lin Division of Hematology & Oncology
- Ming-Chung Kao Division of Hematology & Oncology
- Jin-Hou Wu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 何景良 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Ya-Ping Chen Division of General Internal Medicine
- Ya-Ting Hsu Division of General Internal Medicine
- Sin-Syue Li Division of General Internal Medicine
- Chun-Hui Lee Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Yi-Chang Liu Division of General Internal Medicine
- Shih-Feng Cho Division of General Internal Medicine
- Jeng-Shiun Du Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 林明恩 未分科
- CHENG-HONG TSAI 未分科
- Chien-Chin Lin 未分科
- HSIN-AN HOU 未分科
- - - 未分科
- Chieh-Lung Cheng 未分科
- 田豐銘 未分科
- Huai-Hsuan Huang Division of General Internal Medicine
- - - 未分科
- MING YAO 未分科
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
1. Occurrence of treatment-emergent adverse events (TEAEs)
2. Occurrence of TEAEs leading to withdrawal of rozanolixizumab
Secondary End Point (repeat as necessary)
1. Stable Clinically Meaningful Response without rescue therapy at ≥70% of the visits starting after the second dose of rozanolixizumab until Week 54
2. Change from Baseline in European Quality of Life-5 Dimension 5 Levels Assessment (EQ5D-5L)
3. Change from Baseline in Short-Form 36-Item (SF-36) Survey
4. Change from Baseline in ITP-Patient Assessment Questionnaire (ITPPAQ)
5. Response defined as change from Baseline at or above the defined threshold for ITP Patient Assessment Questionnaire (ITP-PAQ) Symptoms Score
6. Minimum value in total serum immunoglobulin G (IgG) concentration over time
7. Maximum decrease from Baseline in total serum IgG concentration over time
8. Change from Baseline in serum IgG subclasses concentration over time
9. Change from Baseline in serum Ig concentrations (IgA, IgE, IgM) over time
10. Change from Baseline in Physical Fatigue Instrument
11. Change from Baseline in Patient Global Impression of Severity (PGIS)
12. Change from Baseline in Patient Global Impression of Change (PGIC)
13. Area under the curve (AUC) of the oral steroid dose over time
Inclution Criteria
-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
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 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)
The Estimated Number of Participants
-
Taiwan
16 participants
-
Global
210 participants
