WHO ICTRP trial

A study of belumosudil in children with chronic graft versus host disease…

CTIS2024-511508-18-00 · EU Clinical Trials Information System · Recruiting

Key facts

Trial ID CTIS2024-511508-18-00
Public title A study of belumosudil in children with chronic graft versus host disease (schoolROCK).
Scientific title An open-label, Phase 1/2, multicenter study of belumosudil in children aged 1 to <18 years requiring systemic treatment for active moderate-to-severe chronic graft versus host disease (cGVHD). - DFI17893
Primary sponsor Sanofi-Aventis Recherche & Developpement
Registry EU Clinical Trials Information System
Recruitment status Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): Yes Therapeutic exploratory (Phase II): Yes Therapeutic confirmatory - (Phase III): No Therapeutic use - (Phase IV): No
Countries Turkey;United Kingdom;Canada;Japan;United States;Israel;China;France;Germany;Belgium;Italy;Netherlands;Spain
Conditions Chronic graft versus host disease. MedDRA version: 27.0Level: PTClassification code: 10066261Term: Chronic graft versus host disease Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Interventions Product Name: belumosudil, Product Code:PRD12275526, Pharmaceutical Form: ORAL SUSPENSION, Other descriptive name: , Strength: , Product Name: SAR445761 - belumosudil, Product Code:PRD10413339, Pharmaceutical Form: FILM-COATED TABLET, Other…
Registration date Apr 6, 2025
Target size 50
Secondary IDs U1111-1281-0103
Registry page euclinicaltrials.eu

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