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Kinase Inhibitor
KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis
Milwaukee, WI
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 for db period: from day 1 (week 0) up to week 28; for ole period: from week 29 up to 4 weeks post last study drug administration (i.e., up to week 56)
Summary
This trial is testing a drug called belumosudil to see if it is effective and safe for treating a disease called diffuse cutaneous systematic sclerosis. Sixty people will be given the drug or a placebo for 28 weeks and then the trial will continue for another 24 weeks with everyone given the drug.
See full description
Eligible Conditions
- Multiple sclerosis
- Scleroderma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for db period: from day 1 (week 0) up to week 28; for ole period: from week 29 up to 4 weeks post last study drug administration (i.e., up to week 56)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for db period: from day 1 (week 0) up to week 28; for ole period: from week 29 up to 4 weeks post last study drug administration (i.e., up to week 56)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
DB Period: Number of Participants With Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) Score Greater Than or Equal to (>=) 60 Percent (%) at Week 24
Secondary study objectives
DB Period: Change From Baseline in 12-lead Electrocardiogram (ECG) Values: Heart Rate at Week 24
DB Period: Change From Baseline in 12-lead Electrocardiogram Values: PR Interval, RR Interval, QRS Interval, QT Interval and QTcF Interval at Week 24
DB Period: Change From Baseline in Clinical Chemistry Parameter: Albumin, Globulin and Protein at Week 24
+67 moreOther study objectives
PD: Gene Expression of Skin Biopsy Samples
PD: Histology of Skin Biopsy Samples
Pharmacodynamic (PD): Biomarker Analysis
Side 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
Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: OLE Period: Placebo/Belumosudil QDExperimental Treatment1 Intervention
Participants who had received placebo in the DB period were entered and re-randomized into OLE period and received belumosudil 200 mg tablet QD orally for 24 weeks (i.e., up to Week 52) in the OLE period.
Group II: OLE Period: Placebo/Belumosudil BIDExperimental Treatment1 Intervention
Participants who had received placebo in the DB period were entered and re-randomized into OLE period and received belumosudil 200 mg tablet BID orally for 24 weeks (i.e., up to Week 52) in the OLE period.
Group III: Belumosudil QD/Belumosudil QDExperimental Treatment1 Intervention
Participants received belumosudil 200 mg tablet, QD orally for 28 weeks during the DB period. After completion of DB period, participants entered open-label extension (OLE) period and continued to receive belumosudil 200 mg tablet QD orally for 24 weeks in OLE period (i.e., up to Week 52).
Group IV: Belumosudil BID/Belumosudil BIDExperimental Treatment1 Intervention
Participants received belumosudil 200 mg tablet BID orally, for 28 weeks during the DB period. After completion of DB period, participants entered OLE period and continued to receive belumosudil 200 mg tablet BID orally for 24 weeks in OLE period (i.e., up to Week 52).
Group V: DB Period: PlaceboPlacebo Group1 Intervention
Participants received placebo (matched to belumosudil) tablet, orally for 28 weeks during the DB period.
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:University of Pittsburgh Medical Center_Site number 149· Pittsburgh, PA· 163 miles
Who is running the clinical trial?
Kadmon Corporation, LLCLead Sponsor
37 Previous Clinical Trials
1,675 Total Patients Enrolled
Kadmon, a Sanofi CompanyLead Sponsor
13 Previous Clinical Trials
635 Total Patients Enrolled