Belumosudil (KD025) for Graft vs Host Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Graft vs Host Disease+1 More
Belumosudil (KD025) - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it can help people with a certain type of cancer who have tried other treatments unsuccessfully.

Eligible Conditions
  • Graft vs Host Disease
  • Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Graft vs Host Disease

Study Objectives

1 Primary · 16 Secondary · Reporting Duration: 6 months

6 months
Change in Lee Symptom Scale Score
Change in cGVHD severity as based on the Physician-reported global cGVHD Activity Assessment
Change in calcineurin inhibitor dose
Change in corticosteroid dose
Change in symptom activity as based on cGVHD Activity Assessment Patient Self-Report
Duration of Response (DOR)
Failure-free survival (FFS)
Overall Response Rate (ORR)
Overall Survival (OS)
Percentage of subjects who have a best response of PR or CR
Response rate by organ system
Time to Response
Time to next treatment
Hour 12
Determine the Peak Plasma Concentration (Cmax) of belumosudil
Determine the area under the plasma concentration versus time curve (AUC) of belumosudil
Determine the half-life (T1/2) of belumosudil
Determine the observed time to reach peak plasma concentration (Tmax) of belumosudil

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Graft vs Host Disease

Trial Design

2 Treatment Groups

Arm B: belumosudil 200 mg BID
1 of 2
Arm A: belumosudil 200 mg QD
1 of 2
Experimental Treatment

175 Total Participants · 2 Treatment Groups

Primary Treatment: Belumosudil (KD025) · No Placebo Group · Phase 2

Arm B: belumosudil 200 mg BID
Drug
Experimental Group · 1 Intervention: Belumosudil (KD025) · Intervention Types: Drug
Arm A: belumosudil 200 mg QD
Drug
Experimental Group · 1 Intervention: Belumosudil (KD025) · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belumosudil
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

Kadmon Corporation, LLCLead Sponsor
37 Previous Clinical Trials
1,581 Total Patients Enrolled
2 Trials studying Graft vs Host Disease
77 Patients Enrolled for Graft vs Host Disease
Kadmon, a Sanofi CompanyLead Sponsor
9 Previous Clinical Trials
393 Total Patients Enrolled
3 Trials studying Graft vs Host Disease
89 Patients Enrolled for Graft vs Host Disease

Eligibility Criteria

Age Any Age · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are aged 16 years or older.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: October 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References