Clinical trial • Phase III • Immunology|Rare Disease

rilzabrutinib for Immune thrombocytopenic purpura | Immune Thrombocytopenia Purpura

Phase III trial of rilzabrutinib for Immune thrombocytopenic purpura | Immune Thrombocytopenia Purpura. 24 participants.

Overview

Trial Therapeutic Area
Immunology|Rare Disease
Trial Disease
Immune thrombocytopenic purpura | Immune Thrombocytopenia Purpura
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
13-03-2026
First CTIS Authorization Date
11-05-2026

Trial design

Phase III trial in Germany.

Target Sample Size
24

Recruitment

Planned Sample Size
24
Recruitment Window Months
6

Geography

Total Number Of Sites
1
Total Number Of Participants
24

Germany

Earliest CTIS Part Ii Submission Date
24-04-2026
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
17
Number Of Sites
1
Number Of Participants
24

Sites

Site Name
Klinikum Westend Haus 31, Spandauer Damm 130, Charlottenburg
Department Name
001: Parexel Early Phase Unit Berlin
Contact Person Name
Camila Rincon
Contact Person Email
camila.rincon@parexel.com
Number Of Participants
24

Sponsor

Primary sponsor

Full Name
Sanofi-Aventis Recherche & Developpement
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Contract research organisations

Name
PAREXEL International GmbH

Investigational products

Investigational Product Name
rilzabrutinib (SAR444671)
Active Substance
rilzabrutinib
Modality
Small molecule
Combination Treatment
Yes

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