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

NCT04680975 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-06-05

Study results available
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Summary

This was a phase 2, open-label, single-cohort, multicenter trial of belumosudil in participants with Diffuse Cutaneous Systemic Sclerosis (dcSSc). An estimated total of 12 to 15 participants would receive belumosudil 200 milligrams (mg) administered orally (PO) twice daily (BID) for 52 weeks. The primary analysis was at 24 weeks.

Conditions

  • Diffuse Cutaneous Systemic Sclerosis

Interventions

DRUG

Belumosudil

10 participants with dcSSc received belumosudil 200 mg PO BID for 52 weeks

Sponsors & Collaborators

  • Kadmon, a Sanofi Company

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-03
Primary Completion
2022-05-10
Completion
2022-12-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04680975 on ClinicalTrials.gov