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A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.
NCT06143891 · View on ClinicalTrials.gov ↗
Study Summary
This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD. The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically meaningful cGVHD progression (defined as progression requiring addition of new systemic treatment for cGVHD), relapse/recurrence of the underlying disease, participant starts new systemic treatment for cGVHD or experiences an unacceptable toxicity, at the request of the participants or the investigators, or until the end of study is reached, whichever comes first; at least 30 days follow-up of adverse events (AEs) after the last dose until resolution or stabilization, if applicable; and long-term follow-up until death or study close-out, whichever comes first.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Belumosudil
- DRUG Prednisone
- DRUG Prednisolone
Study Locations (20)
California
- City of Hope National Medical Center- Site Number : 8400001 — Duarte
- University of California San Francisco - Parnassus Heights- Site Number : 8400035 — San Francisco
North Carolina
- UNC Children's Hospital- Site Number : 8400025 — Chapel Hill
- Atrium Health Wake Forest Baptist Medical Center - Winston-Salem - Medical Center Boulevard- Site Number : 8400007 — Winston-Salem
Ohio
- Oncology Hematology Care - Kenwood- Site Number : 8400030 — Cincinnati
- The Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute- Site Number : 8400026 — Columbus
Texas
- St. David's South Austin Medical Center- Site Number : 8400002 — Austin
- Texas Oncology - Dallas - Worth Street- Site Number : 8400010 — Dallas
Arkansas
- University of Arkansas for Medical Sciences-Site Number : 8400019 — Little Rock
Florida
- AdventHealth Orlando- Site Number : 8400023 — Orlando
Georgia
- The Hope Clinic of Emory University- Site Number : 8400020 — Decatur
Illinois
- Northwestern University- Site Number : 8400017 — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2024-01-23 |
| Est. Completion | 2028-09-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06143891
The ClinicalTrials.gov registry entry for NCT06143891 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Graft Versus Host Disease appearing as the primary indexed condition, and to 4 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06143891 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, North Carolina, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06143891 about?
NCT06143891 is a clinical study titled "A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.". This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD. The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically meaningful cGVHD progression (defined as progression requiring addition of ...
What is the current status of trial NCT06143891?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 260 participants. The study started on 2024-01-23. Estimated completion is 2028-09-29.
What conditions does trial NCT06143891 study?
This clinical trial studies the following conditions: Chronic Graft Versus Host Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06143891?
The interventions under investigation include: Placebo (DRUG), Belumosudil (DRUG), Prednisone (DRUG), Prednisolone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06143891?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06143891 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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