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NCT06143891 · ClinicalTrials.gov registry record · Phase 3
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.
A Phase 3 study of Chronic Graft Versus Host Disease, sponsored by Sanofi.
- Active
- Registry status
- Phase 3
- Development phase
- 260
- Enrollment target
- 20
- Study locations
NCT06143891 is a Phase 3 study of Chronic Graft Versus Host Disease that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 260 participants, above the 108-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (141% higher). The trial reports 20 study locations across 16 states.
The verdict
NCT06143891, a Phase 3 study of Chronic Graft Versus Host Disease, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 260 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 108-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (141% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
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.
NCT06143891 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, North Carolina, Ohio.
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.
What interventions are being tested in trial NCT06143891?
The interventions under investigation include: Placebo (DRUG), Belumosudil (DRUG), Prednisone (DRUG), Prednisolone (DRUG).
Who is sponsoring clinical trial NCT06143891?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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