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TP0004

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)

Brief summary

The purpose of this study is to assess the long-term safety, tolerability and clinical efficacy of repeated treatment with rozanolixizumab.

Medical Condition

Primary Immune Thrombocytopenia

Min. Age

18
Years

Max. Age

-

Who Can Join?

All

Status

Enrolling by invitation
Inclusion 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 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
-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 Medication Description

Study Medication:

rozanolixizumab

Other Descriptive Name:

UCB7665

Placebo

No

Comparator:

No

Study Dates

December 2020

Actual Start Date of Enrollment

September 2023

Planned Study Completion Date

General Information

Study ID:
TP0004
EudraCT Number:
2019-000883-40
CT.gov Number:
NCT04596995
Phase:
Phase 3

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