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.
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
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