A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK)

Recruiting Phase 2 Interventional Study
Chronic Graft Versus Host Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
1 – 18
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
37 (estimated)
Sponsor
Sanofi · Industry
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About This Trial
This is an open-label, single group, Phase 1/2, 1-arm study for treatment of children aged 1 to \<18 years with active moderate-to-severe cGVHD that is refractory to or recurred after at least 2 prior lines of systemic therapy for cGVHD. The purpose of Phase 1 is to determine the PK profiles and to establish the Recommended Pediatric Equivalent Dose (RPED) of belumosudil in participants aged 1 to…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Participant must be 1 to \<18 years of age, at the time the consent/assent is signed. For Phase 1: participant must be 1 to \<12 years of age, at the time the consent/assent is signed. For Phase 2: participant must be 1 to \<18 years of age, at the time the consent/assent is s…
Contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610

contact-us@sanofi.com

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