Loading clinical trials...

TERMINATEDPHASE3

A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

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)

NCT04596995•UCB Biopharma SRL

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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:
•1. 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
•2. A female participant is eligible to participate if she is not pregnant as confirmed by a negative urine pregnancy test and 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 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)

Locations (27)

Tp0004 50243

Boston, Massachusetts, United States

Tp0004 20179

Fuzhou, China

Tp0004 20185

Jinan, China

Tp0004 20194

Wuxi, China

Tp0004 20050

Tbilisi, Georgia

Tp0004 40369

Berlin, Germany

Tp0004 40202

Győr, Hungary

Tp0004 40178

Nyíregyháza, Hungary

Tp0004 40208

Florence, Italy

Tp0004 20039

Iruma-gun, Japan

Key Dates

Start Date

January 6, 2021

Primary Completion Date

December 21, 2022

Completion Date

December 21, 2022

Last Updated

February 5, 2024

Enrollment

ACTUAL participants

Conditions

Primary Immune Thrombocytopenia

Interventions

Rozanolixizumab

DRUG

Safety Study of CC312 in Autoimmune Disease Patients

NCT06888960

Systemic Lupus Erythematosus (SLE)Idiopathic Inflammatory Myopathy (IIM)+4 more

View study

ACTIVE_NOT_RECRUITINGPHASE2

Study of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia (ITP)

NCT06594146

Primary Immune Thrombocytopenia

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

Inclusion Criteria

Exclusion Criteria

Safety Study of CC312 in Autoimmune Disease Patients

Study of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia (ITP)

A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia

Intravenous Immunoglobulin (IVIG, Bioven) Efficacy and Safety in Chronic Primary Immune Thrombocytopenia (ITP) in Adults

Evaluation of the Use of Thrombopoietin Receptor Agonists in Adults With Primary ITP in Europe

An Observational, Multicenter Study to Evaluate the Safety and Effectiveness of Hetrombopag in Patients With ITP or AA