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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

Must not have

Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 48 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has returned or I have a lymph-related disease after a transplant.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic procedure

Overall Response Rate (ORR)

Secondary study objectives

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

+11 more

Side effects data

From 2014 Phase 2 trial • 8 Patients • NCT02106195

25%

Transaminase increased

13%

Nephrolithiasis

13%

Nausea

13%

Vomiting

13%

Anastomotic ulcer

13%

Somnolence

13%

Pyrexia

13%

Anastomotic ulder

13%

Hypokalemia

13%

Rib Fracture

13%

Fall

13%

Tooth ache

100%

80%

60%

40%

20%

Study treatment Arm

Belumosudil 200 mg PO QD

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met