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A Phase 3, Open-label, Multicenter Continuation Trial to Evaluate the Long-term Safety and Efficacy of Mezagitamab Subcutaneous Injection in Adults with Chronic Primary Immune Thrombocytopenia

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521692-31-00
Acronym
TAK-079-3003
Enrollment
77
Registered
2025-11-04
Start date
2025-12-19
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Primary Immune Thrombocytopenia

Brief summary

01. Occurrence of TEAEs and serious TEAEs., 02. Occurrence of TEAEs leading to permanent withdrawal of mezagitamab

Detailed description

01• Duration of platelet response. • Duration between on-demand treatment courses. • Time to initiation of the first on-demand treatment course. • Occurrence of complete response. • Occurrence of ITP remission., 02. Reduction in dose and/or frequency of concomitant ITP medications throughout the trial., 03. Use of rescue therapy., 04. The PK concentration at selected timepoints during and after intervention., 05. Occurrence of ADA and NAb.

Interventions

DRUGMezagitamab

Sponsors

Takeda Development Center Americas Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
01. Occurrence of TEAEs and serious TEAEs., 02. Occurrence of TEAEs leading to permanent withdrawal of mezagitamab—

Secondary

MeasureTime frame
01• Duration of platelet response. • Duration between on-demand treatment courses. • Time to initiation of the first on-demand treatment course. • Occurrence of complete response. • Occurrence of ITP remission., 02. Reduction in dose and/or frequency of concomitant ITP medications throughout the trial., 03. Use of rescue therapy., 04. The PK concentration at selected timepoints during and after intervention., 05. Occurrence of ADA and NAb.—

Countries

Bulgaria, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026