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Rho kinase inhibitor

Belumosudil for Systemic Sclerosis (dcSSC Trial)

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 week 8, 16, 36 and 52

Awards & highlights

dcSSC Trial Summary

This trial is testing a new drug, belumosudil, to see if it helps people with a disease called diffuse cutaneous systemic sclerosis. Up to 15 people will take the drug for 52 weeks. The trial will mainly look at how the drug affects people after 24 weeks.

Eligible Conditions

Systemic Sclerosis

dcSSC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 8, 16, 36 and 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 8, 16, 36 and 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8, 16, 36 and 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) Score at Week 24

Secondary outcome measures

Change From Baseline in Forced Vital Capacity (FVC) Level at Weeks 8, 16, 36, and 52

Change From Baseline in Modified Rodnan Skin Thickness Score (mRSS) at Weeks 8, 16, 36, and 52

Change From Baseline in Patient Global Assessment of Participant's Overall Health Using Visual Analogue Scale (VAS) Score at Weeks 8, 16, 36, and 52

+9 more

Other outcome measures

Fibrosis

Side effects data

From 2014 Phase 2 trial • 8 Patients • NCT02106195

25%

Transaminase increased

13%

Nausea

13%

Vomiting

13%

Pyrexia

13%

Fall

13%

Rib Fracture

13%

Tooth ache

13%

Nephrolithiasis

13%

Anastomotic ulder

13%

Somnolence

13%

Hypokalemia

13%

Anastomotic ulcer

100%

80%

60%

40%

20%

Study treatment Arm

Belumosudil 200 mg PO QD

dcSSC Trial Design

1Treatment groups

Experimental Treatment

Group I: BelumosudilExperimental Treatment1 Intervention

Participants received belumosudil 200 mg tablet orally PO, BID for 52 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Belumosudil

2018

Completed Phase 2

~320

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Kadmon Corporation, LLCLead Sponsor

37 Previous Clinical Trials

1,701 Total Patients Enrolled

Kadmon, a Sanofi CompanyLead Sponsor

13 Previous Clinical Trials

661 Total Patients Enrolled

Frequently Asked Questions

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

Are there any vacant slots in the clinical trial for potential participants?

"Sadly, this clinical trial is not currently taking on any new participants. This research project was initially posted on March 3rd 2021 and then modified for the last time in September 9th 2022. Nevertheless, there are 527 other trials actively enrolling patients presently."

Answered by AI

Could you provide a synopsis of the scholarly research that has been done on Belumosudil?

"Presently, there are 6 ongoing studies concerning Belumosudil. None of those live trials have reached Phase 3 yet. Although the majority of these examinations occur in New york City, 140 disparate locations across the nation are running tests on this particular medication."

Answered by AI

What is the current number of participants being administered the experimental treatment?

"This clinical trial is no longer recruiting new patients. It was first submitted on March 3rd 2021, and last modified on September 9th 2022. Currently, there are 521 scleroderma-related studies actively enrolling individuals as well as 6 trials for Belumosudil that participants can join."

Answered by AI

Does this investigation provide unique insights into the topic?

"Currently, Belumosudil is the subject of 6 studies spanning 56 cities and 2 countries. The inaugural investigation was conducted by Kadmon Corporation, LLC in 2018 with 175 participants partaking in Phase 2 drug approval; since then 10 trials have been concluded."

Answered by AI

Is this clinical research initiative being conducted in several locations across the US?

"For this trial, there are 9 potential sites for enrolment. These include Virginia Mason Medical Center (site 145) in Seattle, Yale University School of Medicine (site 140) in New Haven, and the University of California Los Angeles Medical Centre (site 104) in LA; as well as 6 other centres."

Answered by AI

What potential adverse reactions should patients be aware of with Belumosudil?

"There is some evidence of Belumosudil's safety, which gave it a rating of 2 on the 1-3 scale. As this drug is in Phase 2 trials, there has not yet been sufficient data to support its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis

2021. "Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04680975.