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Kinase Inhibitor

Extended Belumosudil Treatment for Graft-versus-Host Disease

Phase 2

Waitlist Available

Research Sponsored by Kadmon Corporation, LLC

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial is testing a new arthritis drug, and will follow patients who have already been treated with the drug to see how well it works.

Who is the study for?

This trial is for individuals who have previously been treated with Belumosudil in studies KD025-208 or KD025-213, either currently receiving the drug or in long-term follow-up. It's also open to adults from a companion study who've had at least 6 months of treatment or are in follow-up. Pregnant or breastfeeding women and those unlikely to follow the protocol are excluded.Check my eligibility

What is being tested?

The trial is testing different dosages and schedules of Belumosudil: twice daily (BID) at 200 mg, once daily (QD) at both 200 mg and 400 mg. The aim is to understand the effects of extended treatment and monitor participants after they finish taking the medication.See study design

What are the potential side effects?

While specific side effects for Belumosudil aren't listed here, similar medications can cause immune system reactions, liver issues, diarrhea, fatigue, respiratory problems like coughing or shortness of breath, and potential risk of infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Adverse Events

Duration of Response

Failure Free Survival

Secondary outcome measures

Change in Lee Symptom Scale Score: Duration of a ≥7 point reduction

Change in Lee Symptom Scale Score: Number of subjects with a ≥7 point reduction/≥7 point reduction on 2 consecutive assessments

Change in cGVHD Global Severity Rating using the Clinician-reported Global cGVHD Activity Assessment (Appendix B: Clinician-reported Global cGVHD Activity Assessment)

+7 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C: belumosudil 400 mg QDExperimental Treatment1 Intervention

The assigned arm is per the previous study KD025-213 or study KD025-208

Group II: Arm B: belumosudil 200 mg BIDExperimental Treatment1 Intervention

The assigned arm is per the previous study KD025-213 or study KD025-208

Group III: Arm A: belumosudil 200 mg QDExperimental Treatment1 Intervention

The assigned arm is per the previous study KD025-213 or study KD025-208

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Kadmon Corporation, LLCLead Sponsor

37 Previous Clinical Trials

1,688 Total Patients Enrolled

Kadmon, a Sanofi CompanyLead Sponsor

13 Previous Clinical Trials

648 Total Patients Enrolled

Media Library

Belumosudil (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05305989 — Phase 2

Graft-versus-Host Disease Research Study Groups: Arm A: belumosudil 200 mg QD, Arm B: belumosudil 200 mg BID, Arm C: belumosudil 400 mg QD

Graft-versus-Host Disease Clinical Trial 2023: Belumosudil Highlights & Side Effects. Trial Name: NCT05305989 — Phase 2

Belumosudil (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05305989 — Phase 2

Frequently Asked Questions

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

Has Belumosudil 200 mg QD been cleared by the Federal Drug Administration?

"The safety of Belumosudil 200 mg QD was rated a 2 due to the fact that, while phase two trials have collected data measuring its safety, efficacy assessments are still incomplete."

Answered by AI

Are there various sites where this clinical trial is currently being conducted within the state?

"The list of participating medical centres for this clinical trial includes Washington University School of Medicine_Site number 125 in Saint Louis, Fred Hutchinson Cancer Research Center_Site number 052 in Seattle, Texas Transplant Institute_Site number 079 in San Antonio and 16 other locations."

Answered by AI

Is recruitment for this experiment taking place at present?

"Per information hosted on clinicaltrials.gov, the present trial is not recruiting participants. It was initially posted in February 2022 and revised last September without any additional recruitment efforts. Nevertheless, there are 169 other trials that are actively welcoming new participants at this moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213

2022. "Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05305989.

All > Graft Vs Host Disease