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Rho-associated protein kinase (ROCK) inhibitor

Belumosudil 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 7 years
Awards & highlights

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
  • Chronic Graft-versus-Host Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 7 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
Overall Response Rate (ORR)
Secondary outcome measures
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
+14 more

Side effects data

From 2022 Phase 2 trial • 54 Patients • NCT02841995
48%
Fatigue
43%
Nausea
33%
Upper respiratory tract infection
33%
Diarrhoea
33%
Cough
29%
Muscle spasms
29%
Oedema peripheral
29%
Headache
29%
Dyspnoea
24%
Arthralgia
19%
Decreased appetite
19%
Vision blurred
19%
Pain in extremity
19%
Hypertension
19%
Abdominal pain
19%
Vomiting
14%
Hyperkalaemia
14%
Contusion
14%
Pyrexia
14%
Myalgia
14%
Conjunctivitis
14%
Pneumonia
14%
Hypoxia
14%
Hypothyroidism
14%
Constipation
14%
Hyperglycaemia
14%
Hyperuricaemia
14%
Tremor
14%
Anxiety
14%
Depression
14%
Insomnia
10%
Hyponatraemia
10%
Dehydration
10%
Alanine aminotransferase increased
10%
Skin abrasion
10%
Influenza like illness
10%
Weight decreased
10%
Influenza
10%
Tachycardia
10%
Dysphagia
10%
Blood creatinine increased
10%
Respiratory syncytial virus infection
10%
Dry eye
10%
Gastrooesophageal reflux disease
10%
Muscular weakness
10%
Acute kidney injury
10%
Photophobia
10%
Dizziness
5%
Pneumonia viral
5%
Myelodysplastic syndrome
5%
Blepharitis
5%
Leukaemia recurrent
5%
Musculoskeletal chest pain
5%
Varicella zoster virus infection
5%
Limb injury
5%
Hypophosphataemia
5%
Acute lymphocytic leukaemia recurrent
5%
Small intestinal obstruction
5%
Graft versus host disease in lung
5%
Cardiac arrest
5%
Leukocytosis
5%
Thrombocytopenia
5%
Generalised oedema
5%
Urinary retention
5%
Palpitations
5%
Conjunctival haemorrhage
5%
Pain
5%
Nasal congestion
5%
Blister
5%
Flatulence
5%
Non-cardiac chest pain
5%
Sinusitis
5%
Bronchitis
5%
Hordeolum
5%
Hypomagnesaemia
5%
Back pain
5%
Joint range of motion decreased
5%
Upper-airway cough syndrome
5%
Pregnancy of partner
5%
Dyspepsia
5%
Aspartate aminotransferase increased
5%
Hypoaesthesia
5%
Pleural effusion
5%
Neutrophil count decreased
5%
Muscle spasticity
5%
Urinary tract pain
5%
Dry skin
5%
Fall
5%
Hyperthyroidism
5%
Abdominal distension
5%
Glucose urine present
5%
Hypocalcaemia
5%
Neuropathy peripheral
5%
Paraesthesia
5%
Haematuria
5%
Oropharyngeal pain
5%
Productive cough
5%
Pulmonary mass
5%
Actinic keratosis
5%
Stomatitis
5%
Blood cholesterol increased
5%
Pericardial effusion
5%
Abdominal wall haematoma
5%
Febrile neutropenia
5%
Weight increased
5%
White blood cell count decreased
5%
Hyperhidrosis
5%
Rash
5%
Embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 3 400 mg QD
Cohort 1 200 mg QD
Cohort 2 200 mg BID

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B: belumosudil 200 mg BIDExperimental Treatment1 Intervention
Eligible subjects randomized to arm B will take belumosudil 200 mg twice daily
Group II: Arm A: belumosudil 200 mg QDExperimental Treatment1 Intervention
Eligible subjects randomized to arm A will take belumosudil 200 mg once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belumosudil (KD025)
2016
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Kadmon Corporation, LLCLead Sponsor
37 Previous Clinical Trials
1,552 Total Patients Enrolled
Kadmon, a Sanofi CompanyLead Sponsor
13 Previous Clinical Trials
512 Total Patients Enrolled

Media Library

Belumosudil (KD025) (Rho-associated protein kinase (ROCK) inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03640481 — Phase 2
Graft-versus-Host Disease Research Study Groups: Arm B: belumosudil 200 mg BID, Arm A: belumosudil 200 mg QD
Graft-versus-Host Disease Clinical Trial 2023: Belumosudil (KD025) Highlights & Side Effects. Trial Name: NCT03640481 — Phase 2
Belumosudil (KD025) (Rho-associated protein kinase (ROCK) inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03640481 — Phase 2

Frequently Asked Questions

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

How many medical facilities are actively conducting this trial?

"This trial can be accessed in 24 different medical sites, such as The Cleveland Clinic Foundation, The University of Texas MD Anderson Cancer Center and Children's National Medical Center_Site number 163. Additionally, there are 21 other locations where this study is available."

Answered by AI

Is KD025 an acceptable option for people considering potential risks?

"Belumosudil (KD025) has been deemed a 2 on our risk scale due to the existence of some data supporting its safety, though no clinical evidence exists indicating efficacy."

Answered by AI

What is the upper limit for enrollment in this research trial?

"Affirmative. Per the clinicaltrials.gov listing, this experiment is actively recruiting participants having been initially posted on October 11th 2018 and last modified on September 18th 2022. The research team needs 175 individuals across 24 sites to take part in the study."

Answered by AI

What other experiments involving Belumosudil (KD025) have been recorded in the past?

"Currently, 6 trials are underway for Belumosudil (KD025). None of these active studies have reached Phase 3. Most locations conducting research on this treatment can be found in New york City; however, there are 140 sites running experiments overall."

Answered by AI

Is this medical research pioneering an innovative approach?

"Belumosudil (KD025) research has been ongoing since 2018, when it was initially tested by Kadmon Corporation, LLC in a trial of 175 people. Subsequently receiving Phase 2 approval, there are currently 6 live trials for Belumosudil (KD025) across 56 cities and two countries."

Answered by AI

Is this trial currently seeking participants?

"Indeed, clinicaltrials.gov data reveals that this experiment is still recruiting participants. It was issued on October 11th 2018 and last amended on September 18th 2022; so far 175 individuals have been accepted at 24 sites."

Answered by AI
Recent research and studies
~24 spots leftby Apr 2025