Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy
Trial · NCT03640481
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) | mITT population included all randomized participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) | Responder population included participants in the mITT population that achieved a partial or complete response at any post-baseline response assessment. | Weeks | MEDIAN |
| SECONDARY | Number of Participants With Improvement (>=7-Point Reduction [7-PtR] From Baseline) as Assessed by Lee Symptom Scale (LSS) Score | Baseline (Day 1) up to 40.5 months for adult arms; Baseline (Day 1) up to 27.6 months for adolescent arms | mITT population included all randomized participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Best Response by Organ System | From date of randomization until disease progression or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) | mITT population included all randomized participants who received at least one dose of study drug. Only those participants with data collected for each specified category are reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Best Response of PR and CR | From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) | mITT population included all randomized participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Corticosteroid Dose to Greatest Reduction | Baseline (Day 1) and 40.5 months for adult arms; Baseline (Day 1) and 27.6 months for adolescent arms | mITT population included all randomized participants who received at least one dose of study drug. Only those participants with data collected at specified timepoints are reported. | Percent change | MEDIAN |
| SECONDARY | Percentage of Participants With Reduction and Discontinuation of Calcineurin Inhibitor Dose | Baseline (Day 1) up to 40.5 months for adult arms; Baseline (Day 1) up to 27.6 months for adolescent arms | mITT population included all randomized participants who received at least one dose of study drug. Only those participants who received CNI at baseline were included in the analysis. | Percentage of participants | NUMBER |
| SECONDARY | Failure-Free Survival (FFS) | From first dose of study drug to the time of first documentation of response or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) | mITT population included all randomized participants who received at least one dose of study drug. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From first dose of study drug to date of death from any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) | mITT population included all randomized participants who received at least one dose of study drug. | Months | MEDIAN |
| SECONDARY | Number of Participants With Best Response of Global Severity Rating Score as Based on the Clinician-Reported Global cGVHD Activity Assessment | Baseline (Day 1) up to 40.5 months for adult arms; Baseline (Day 1) up to 27.6 months for adolescent arms | mITT population included all randomized participants who received at least one dose of study drug. Only participants with respective global severity rating score categories of \<6, =6-7 and \>7 assessed at baseline are reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Patient Self-Reported Symptom Activity Based on cGVHD Activity Assessment | Baseline (Day 1) and 40.5 months for adult arms; Baseline (Day 1) and 27.6 months for adolescent arms | mITT population included all randomized participants who received at least one dose of study drug. Only those participants with data collected at specified timepoints are reported. | Score on a scale | MEAN |
| SECONDARY | Maximum Concentration Observed (Cmax) of Belumosudil | Cycles 1 and 2: Pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, and 12 hours post dose on Day 1 for adult arms; Cycles 2 and 4: Pre-dose and 3 and 5 hours post dose on Day 1 for adolescent arms | PK population included all study participants who provided samples for dense PK sampling. Only those participants with data collected at specified timepoints are reported. | Nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Observed Time to Reach Peak Plasma Concentration (Tmax) of Belumosudil | Cycles 1 and 2: Pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, and 12 hours post dose on Day 1 for adult arms; Cycles 2 and 4: Pre-dose and 3 and 5 hours post dose on Day 1 for adolescent arms | PK population included all study participants who provided samples for dense PK sampling. Only those participants with data collected at specified timepoints are reported. | Hours | MEDIAN |
| SECONDARY | Area Under the Curve Over Time Interval From 0 to 6 Hours (AUC0-6) of Belumosudil | Cycles 1 and 2: Pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, and 12 hours post dose on Day 1 for adult arms; Cycles 2 and 4: Pre-dose and 3 and 5 hours post dose on Day 1 for adolescent arms | PK population included all study participants who provided samples for dense PK sampling. Only those participants with data collected at specified timepoints are reported. | Hours*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Response (TTR) | From first dose of study drug to the time of first documentation of response or data cut-off, whichever occurred first(maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) | Responder population included participants in the mITT population that achieved a partial or complete response at any post-baseline response assessment. | Weeks | MEDIAN |
| SECONDARY | Time to Next Treatment (TTNT) | From first dose of study drug to the time of new treatment or censoring date, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) | mITT population included all randomized participants who received at least one dose of study drug. | Months | MEDIAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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