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Kinase Inhibitor

Belumosudil for Chronic Graft-Versus-Host Disease

Phase 2

Recruiting

Research Sponsored by Kadmon, a Sanofi Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have persistent cGVHD manifestations and systemic therapy is indicated

Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 48 months

Awards & highlights

Study Summary

This trial tests the safety and effectiveness of a new drug for people with cGVHD who have had 2 prior treatments. Participation lasts up to 4 weeks and follow-up every 12 weeks.

Who is the study for?

This trial is for Black, African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander individuals aged 12+ with chronic Graft Versus Host Disease (cGVHD) who have tried at least two systemic therapies. Participants must be in stable condition with a certain performance score and not on specific treatments like ibrutinib or ruxolitinib recently.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of an oral drug called Belumosudil in patients with cGVHD. The treatment period includes up to four weeks of screening, ongoing treatment until disease progression, followed by a safety check-up after four weeks and long-term follow-ups every three months.See study design

What are the potential side effects?

While the specific side effects are not listed here, participants will be monitored for any adverse reactions to Belumosudil during their treatment phase as well as throughout the safety follow-up period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have ongoing symptoms from a chronic graft-versus-host disease needing systemic treatment.

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I am using two forms of birth control and am not pregnant or breastfeeding.

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I can care for myself but may not be able to do active work or play.

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I am at least 12 years old and weigh 40 kg or more.

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I have had 2 to 5 treatments for chronic graft-versus-host disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in corrected QT interval using Fridericia's formula (QTc[F])

Heart rate

Diastolic blood pressure

+3 more

Secondary outcome measures

Change from baseline in cGVHD global severity rating using the Clinician-Reported Global cGVHD Activity Assessment

Change from baseline in calcineurin inhibitor dose

Adrenal Cortex Hormones

+12 more

Side effects data

From 2014 Phase 2 trial • 8 Patients • NCT02106195

25%

Transaminase increased

13%

Nausea

13%

Vomiting

13%

Pyrexia

13%

Fall

13%

Rib Fracture

13%

Tooth ache

13%

Nephrolithiasis

13%

Anastomotic ulder

13%

Somnolence

13%

Hypokalemia

13%

Anastomotic ulcer

100%

80%

60%

40%

20%

Study treatment Arm

Belumosudil 200 mg PO QD

Trial Design

1Treatment groups

Experimental Treatment

Group I: BelumosudilExperimental Treatment1 Intervention

Participants will receive belumosudil orally, once daily (QD) or twice daily (BID) if they are taking strong CYP3A4 inducers or proton pump inhibitors.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Belumosudil

2018

Completed Phase 2

~320

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kadmon, a Sanofi CompanyLead Sponsor

13 Previous Clinical Trials

635 Total Patients Enrolled

Clinical Sciences & OperationsStudy DirectorSanofi

862 Previous Clinical Trials

2,019,802 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any openings for this experiment?

"Affirmative, the clinicaltrials.gov database attests that this trial is still recruiting participants to join. First posted on January 16th 2024 and updated as of November 21st 2023, 36 individuals who meet the criteria are needed from 3 specific medical sites."

Answered by AI

What potential dangers should be taken into consideration when using Belumosudil?

"Belumosudil received a 2 on our risk assessment scale. This is because of the Phase 2 trial designation, indicating that there are studies which support its safety but none with evidence of efficacy."

Answered by AI

How many participants are currently enrolled in this trial?

"Affirmative. The clinical trial portal points to this study actively seeking participants, with the first post made on January 16th 2024 and last update on November 21st 2023. 36 enrollees are needed from 3 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of Oral Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander Male and Female Participants Aged 12 Years and Above With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy

2024. "Safety and Efficacy of Oral Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander Male and Female Participants Aged 12 Years and Above With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05567406.

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