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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) (TP0004)

A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP)

Sugihara Kazuhiro

UCB Japan Co., Ltd.

8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-002

CTR-JRCT.UCBJapan@ucb.com

& Operation Global Clinical Science

UCB Japan Co., Ltd.

8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo,160-0023

+81-3-6864-7587

CTR_SCC_UCBJapan@UCB.com

Not Recruiting

Aug. 31, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

-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

-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)

Both

Primary immune thrombocytopenia

Study participants receive rozanolixizumab by subcutaneous infusion during the Treatment Period.
Study participants will receive fixed-unit doses of rozanolixizumab across body weight tiers.

- Occurrence of treatment-emergent adverse events (TEAEs)
- Occurrence of TEAEs leading to withdrawal of rozanolixizumab (ie, study discontinuation

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

+81-49-276-1111

June. 22, 2021

Yes

Plan Description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available. IPD Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion. IPD Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. IPD URL https://www.vivli.org

Austria/Belgium/Bulgaria/Canada/China/Croatia/Czechia/Denmark/France/Georgia/Germany/Greece/Hong Kong/Hungary/Italy/Korea/Republic of Moldova/Poland/Romania/Russian Federation/Serbia/Spain/Taiwan/Turkey/Ukraine/United Kingdom/United States