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Rho-associated protein kinase (ROCK) inhibitor
Belumosudil for Graft-versus-Host Disease
Boston, MA
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 from date of randomization until disease progression or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing Belumosudil, a medication for patients with Chronic Graft Versus Host Disease (cGVHD) who have not responded to at least two other treatments. The medication aims to help control the immune system to reduce symptoms.
See full description
Eligible Conditions
- Chronic Graft-versus-Host Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until disease progression or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until disease progression or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate (ORR)
Secondary study objectives
Area Under the Curve Over Time Interval From 0 to 6 Hours (AUC0-6) of Belumosudil
Change From Baseline in Patient Self-Reported Symptom Activity Based on cGVHD Activity Assessment
Duration of Response (DOR)
+12 moreSide effects data
From 2022 Phase 2 trial • 54 Patients • NCT0284199553%
Upper respiratory tract infection
35%
Diarrhoea
35%
Nausea
35%
Fatigue
35%
Alanine aminotransferase increased
29%
Hypertension
29%
Anaemia
29%
Aspartate aminotransferase increased
24%
Gamma-glutamyltransferase increased
24%
Blood alkaline phosphatase increased
24%
Muscular weakness
24%
Headache
18%
Nasal congestion
18%
Oedema peripheral
18%
Pain
18%
Hyperkalaemia
18%
Weight increased
12%
Rash maculo-papular
12%
Gastrooesophageal reflux disease
12%
Vomiting
12%
Erectile dysfunction
12%
Dry eye
12%
Glucose urine present
12%
Vertigo
12%
Abdominal pain
12%
Influenza
12%
Oral candidiasis
12%
Contusion
12%
Fall
12%
Decreased appetite
12%
Dehydration
12%
Hyperglycaemia
12%
Obesity
12%
Tremor
12%
Proteinuria
12%
Productive cough
12%
Sinus pain
12%
Pain in extremity
12%
Dyspnoea
6%
Hypokalaemia
6%
Respiratory tract infection fungal
6%
Leukocytosis
6%
Hypothyroidism
6%
Hair growth abnormal
6%
Lipomatosis
6%
Hypogonadism
6%
Anal incontinence
6%
Hypomagnesaemia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Peripheral coldness
6%
Epstein-Barr virus infection
6%
Generalised oedema
6%
Benign prostatic hyperplasia
6%
Spinal compression fracture
6%
Hyponatraemia
6%
Anaphylactic reaction
6%
Influenza A virus test positive
6%
Pneumonia
6%
Metastases to meninges
6%
Thrombocytosis
6%
Palpitations
6%
Pericardial effusion
6%
Blepharitis
6%
Adrenal insufficiency
6%
Acute respiratory failure
6%
Obliterative bronchiolitis
6%
Blood loss anaemia
6%
Eye irritation
6%
Abdominal distension
6%
Abdominal pain upper
6%
Eyelid margin crusting
6%
Constipation
6%
Dysphagia
6%
Stomatitis
6%
Catheter site haemorrhage
6%
Chills
6%
Impaired healing
6%
Influenza like illness
6%
Pyrexia
6%
Graft versus host disease in gastrointestinal tract
6%
Bronchitis
6%
Fungal infection
6%
Hordeolum
6%
Pseudomonas infection
6%
Respiratory tract infection
6%
Sinusitis
6%
Corneal abrasion
6%
Ligament sprain
6%
Limb injury
6%
Overdose
6%
Transfusion reaction
6%
Blood cholesterol increased
6%
Blood creatine phosphokinase increased
6%
Blood creatinine increased
6%
Bronchoscopy
6%
Neutrophil count decreased
6%
Platelet count decreased
6%
Urine output decreased
6%
Weight decreased
6%
Hyperuricaemia
6%
Type 2 diabetes mellitus
6%
Arthralgia
6%
Muscle spasms
6%
Musculoskeletal chest pain
6%
Myalgia
6%
Neck pain
6%
Hodgkin's disease recurrent
6%
Leukaemia recurrent
6%
Skin papilloma
6%
Hypoaesthesia
6%
Muscle spasticity
6%
Anxiety
6%
Acute kidney injury
6%
Chronic kidney disease
6%
Haematuria
6%
Nephrotic syndrome
6%
Nocturia
6%
Pollakiuria
6%
Testicular pain
6%
Testicular swelling
6%
Acute respiratory distress syndrome
6%
Hypoxia
6%
Oropharyngeal pain
6%
Orthopnoea
6%
Dry skin
6%
White blood cell count decreased
6%
Osteonecrosis
6%
Thoracic spinal stenosis
6%
Epidural lipomatosis
6%
Irritability
6%
Cough
6%
Atelectasis
6%
Dyspnoea exertional
6%
Nail disorder
6%
Pruritus
6%
Rash
6%
Embolism
6%
Hot flush
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1 200 mg QD
Cohort 2 200 mg BID
Cohort 3 400 mg QD
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Arm B: belumosudil 200 mg, BID, adult armExperimental Treatment1 Intervention
Eligible subjects randomized to arm B will take belumosudil 200 mg twice daily
Group II: Arm A: belumosudil 200 mg, QD, adult armExperimental Treatment1 Intervention
Eligible subjects randomized to arm A will take belumosudil 200 mg once daily
Group III: Adolescent arm B: belumosudil 200 mg BIDExperimental Treatment1 Intervention
Eligible subjects randomized to arm B will take belumosudil 200 mg twice daily
Group IV: Adolescent 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
Closest Location:Massachusetts General Hospital_Site number 002· Boston, MA
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received between 2 and 5 different types of medication for chronic graft-versus-host disease (cGVHD).Your cancer has come back or you have a specific type of disease after a transplant.You are currently taking ibrutinib, or if you have taken it before, there needs to be a break of at least 28 days before joining the study.You have been taking a stable dose of glucocorticoid therapy for the past 2 weeks before screening.If you are 16 years or older, you should have a Karnofsky Performance Score of 60 or higher.People at least 12 years old who have had a specific type of cell transplant called allogenic hematopoietic cell transplant.You have ongoing symptoms of chronic graft-versus-host disease and need treatment for it.If you're under 16, you need to have a Lansky Performance Score of 60 or higher.You weigh at least 40 kilograms.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: belumosudil 200 mg, QD, adult arm
- Group 2: Arm B: belumosudil 200 mg, BID, adult arm
- Group 3: Adolescent arm A: belumosudil 200 mg QD
- Group 4: Adolescent arm B: belumosudil 200 mg BID
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.