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Kinase Inhibitor

Belumosudil (KD025) for Systemic Sclerosis

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)
Awards & highlights

Study 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.

Eligible Conditions
  • Systemic Sclerosis

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 more
Other outcome measures
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 • 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

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

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

Frequently Asked Questions

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

Does this research project break new ground for treatments of this sort?

"There are presently 6 ongoing trials for Belumosudil in 56 cities across 2 nations. The first trial was conducted in 2018 and, sponsored by Kadmon Corporation, LLC, it reached Phase 2 of drug approval. A total of 175 patients were involved. Since then, 18299 similar studies have been completed."

Answered by AI

In how many different geographic areas is this trial taking place?

"In addition to other locations, this study is being conducted at Hospital For Special Surgery in New york City, University of Pittsburgh Medical Center_Site number 149 in Pittsburgh, and Medical University of South Carolina_Site number 054 in Charleston."

Answered by AI

Could I potentially qualify to take part in this research?

"The requirements for participation in this clinical trial include a diagnosis of scleroderma, systemic and being between 18-100 years old. Currently, the study is looking to enroll 60 patients."

Answered by AI

What previous research has there been on Belumosudil (KD025)?

"The first study involving Belumosudil (KD025) took place in 2018 at University of Pittsburgh Medical Center Hillman Cancer CenterSite number 132. Since then, there have been 18299 completed trials worldwide. There are currently 6 live clinical trials, a significant portion of which are based out of New york City in the state of New York."

Answered by AI

Is the age limit for this research 80 years or younger?

"The age requirements to enroll in this trial are between 18 and 100 years old."

Answered by AI

Is there a high risk for serious side effects with Belumosudil (KD025)?

"Belumosudil (KD025) is still being studied in clinical trials, so its safety rating is a 2."

Answered by AI

Are there any current openings for patients who wish to participate in this research?

"This study is not currently enrolling patients. It was originally posted on 6/26/2019 and last updated on 9/18/2022. If you are looking for other studies, 537 studies are actively recruiting participants with scleroderma, systemic and 6 studies are actively seeking candidates for Belumosudil (KD025)."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis
2019. "KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03919799.
~6 spots leftby Apr 2025
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