Phase 2
Completed N=23
Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213
Source: ClinicalTrials.gov NCT05305989 ↗Enrolled (actual)
23
Serious AEs
26.1%
Results posted
May 2025
Primary outcomePrimary: Duration of Response (DOR) — NA; NA months
Summary
Extended Treatment and Follow-up of Subjects Treated with Belumosudil in Study KD025-208 or Study KD025-213
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Response (DOR) |
NA; NA | — |
| PRIMARY Number of Participants With a >=7 Point Reduction (7PtR) From Baseline and >=7 Point Reduction From Baseline on 2 Consecutive Post-Baseline Assessments as Assessed by Lee Symptom Scale (LSS) |
8; 2; 0; 8; 1; 0 | — |
| PRIMARY Duration of >=7 Point Reduction as Assessed by Lee Symptom Scale |
67.2; 49.5 | — |
| PRIMARY Time to Next Treatment (TTNT) |
NA; NA; NA | — |
| PRIMARY Failure-Free Survival (FFS) |
NA; NA; NA | — |
| PRIMARY Overall Survival (OS) |
NA; NA; NA | — |
| PRIMARY Percentage of Participants With Complete Response (CR) and Partial Response (PR) |
30.8; 11.1; 0; 30.8; 77.8; 0 | — |
| PRIMARY Number of Participants With Best Response by Organ System |
6; 5; 0; 6; 4; 0 | — |
| PRIMARY Percent Change From Baseline in Corticosteroid Dose to Greatest Reduction |
-50.00; 0.0 | — |
| PRIMARY Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) Based on Clinician-Reported Chronic Graft-Versus-Host-Disease Assessment |
1; 1; 0; 0; 1; 0 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Grade >=3 Treatment-Emergent Adverse Events and Deaths |
8; 7; 0; 4; 2; 0 | — |
Eligibility Criteria
Inclusion Criteria
Subjects must have been treated with belumosudil for at least 1 of the following:
- Actively receiving belumosudil on Study KD025-208 or Study KD025-213
- Is in Long-term Follow-up (LTFU) on Study KD025-208 or Study KD025-213. Long-term Follow-up will be defined as the period after ending treatment with belumosudil and until a FFS event occurs.
- Adult enrolled in the Companion Study under KD025-213 Amendment 2 (01 June 2020) and has received at least 6 months of treatment of belumosudil or is in LTFU
Exclusion Criteria
- Female subject who is pregnant or breastfeeding
- Subject considered unlikely to adhere to treatment and/or follow protocol in the opinion of the Investigator
Data sourced from ClinicalTrials.gov (NCT05305989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.