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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
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.

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

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
Change in Lee Symptom Scale Score
Change in cGVHD severity as based on the Physician-reported global cGVHD Activity Assessment
Change in symptom activity as based on cGVHD Activity Assessment Patient Self-Report
+11 more

Side effects data

From 2022 Phase 2 trial • 54 Patients • NCT02841995
53%
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%
Vomiting
12%
Erectile dysfunction
12%
Gastrooesophageal reflux disease
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%
Leukocytosis
6%
Pleural effusion
6%
Epstein-Barr virus infection
6%
Hyponatraemia
6%
Anal incontinence
6%
Benign prostatic hyperplasia
6%
Hair growth abnormal
6%
Peripheral coldness
6%
Hypokalaemia
6%
Hypomagnesaemia
6%
Hypogonadism
6%
Spinal compression fracture
6%
Hypophosphataemia
6%
Generalised oedema
6%
Lipomatosis
6%
Hypothyroidism
6%
Respiratory tract infection fungal
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

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
~22 spots leftby Dec 2025
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