KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis
Public ClinicalTrials.gov record NCT03919799. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomized, Placebo-controlled, Double-blind, Open-label Extension Multicenter Study to Evaluate the Efficacy and Safety of Belumosudil (KD025) in Subjects With Diffuse Cutaneous Systemic Sclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized, placebo-controlled phase 2 study was seeking to evaluate the efficacy and safety of belumosudil (KD025) for the treatment of diffuse cutaneous systematic sclerosis. Enrolment was terminated earlier than planned for business reasons unrelated to safety. A total of 36 participants were enrolled and randomized into 3 groups to either receive orally administered belumosudil (200 milligrams \[mg\] once daily \[QD\] and 200 mg twice daily \[BID\]) or matched placebo in 1:1:1 ratio in the double-blind (DB) period of this study. Study drug dosing was for 52 weeks: double-blinded for the first 28 weeks followed by an open-label extension of 24 weeks. After unblinding, the participants on belumosudil continued on the same belumosudil dose whereas the participants in the placebo group were re-randomized to one of the belumosudil doses in a 1:1 ratio.
Study identification
- NCT ID
- NCT03919799
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 36 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 25, 2019
- Primary completion
- Aug 8, 2022
- Completion
- Feb 16, 2023
- Last update posted
- Aug 29, 2023
2019 – 2023
United States locations
- U.S. sites
- 26
- U.S. states
- 15
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Viable Research Management_Site number 131 | Phoenix | Arizona | 85004 | — |
| Mayo Clinic - Scottsdale_Site number 150 | Scottsdale | Arizona | 85259 | — |
| University of California, SD_Site number 008 | La Jolla | California | 92037 | — |
| Pacific Arthrirtis Care Center_Site number 136 | Los Angeles | California | 90045 | — |
| University of California - Los Angeles_Site number 104 | Los Angeles | California | 90095 | — |
| Stanford University Medical Center_Site number 143 | Palo Alto | California | 94304 | — |
| University of Connecticut_Site number 147 | Farmington | Connecticut | 06030 | — |
| Yale University School of Medicine_Site number 140 | New Haven | Connecticut | 06520 | — |
| Georgetown University_Site number 035 | Washington D.C. | District of Columbia | 20007 | — |
| St. Francis Medical_Site number 085 | Clearwater | Florida | 33765 | — |
| Omega Research Consultants_Site number 133 | DeBary | Florida | 32713 | — |
| Northwestern Medicine_Site number 124 | Chicago | Illinois | 60611 | — |
| DelRicht Research_Site number 159 | New Orleans | Louisiana | 70115 | — |
| Johns Hopkins University School of Medicine_Site number 134 | Baltimore | Maryland | 21224 | — |
| Massachusetts General Hospital_Site number 002 | Boston | Massachusetts | 02114 | — |
| Boston University_Site number 137 | Boston | Massachusetts | 02118 | — |
| University of Minnesota_Site number 051 | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic_Site number 146 | Rochester | Minnesota | 55905 | — |
| Hospital For Special Surgery_Site number 138 | New York | New York | 10021 | — |
| Columbia University Medical Center_Site number 086 | New York | New York | 10032 | — |
| Thomas Jefferson University Hospital_Site number 096 | Philadelphia | Pennsylvania | 19107 | — |
| University of Pittsburgh Medical Center_Site number 149 | Pittsburgh | Pennsylvania | 15213 | — |
| Medical University of South Carolina_Site number 054 | Charleston | South Carolina | 29425 | — |
| Virginia Mason Medical Center_Site number 145 | Seattle | Washington | 98101 | — |
| Premier Clinical Research_Site number 130 | Spokane | Washington | 99202 | — |
| Froedtert Hospital and the Medical College of Wisconsin_Site number 012 | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03919799, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 29, 2023 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03919799 live on ClinicalTrials.gov.