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A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.
This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD. The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically meaningful cGVHD progression (defined as progression requiring addition of new systemic treatment for cGVHD), relapse/recurrence of the underlying disease, participant starts new systemic treatment for cGVHD or experiences an unacceptable toxicity, at the request of the participants or the investigators, or until the end of study is reached, whichever comes first; at least 30 days follow-up of adverse events (AEs) after the last dose until resolution or stabilization, if applicable; and long-term follow-up until death or study close-out, whichever comes first.
Study details:
Up to 5 years.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 12 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-01-23
Primary completion: 2028-09-29
Study completion finish: 2028-09-29
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT06143891
Intervention or treatment
DRUG: Belumosudil
DRUG: Placebo
DRUG: Prednisone
DRUG: Prednisolone
Conditions
- • Chronic Graft Versus Host Disease
Find a site
Closest Location:
Investigational Site Number : 0360005
Research sites nearby
Select from list below to view details:
Investigational Site Number : 0360005
Westmead, New South Wales, Australia
Investigational Site Number : 0360003
Herston, Queensland, Australia
Investigational Site Number : 0360001
Melbourne, Victoria, Australia
Investigational Site Number : 0360004
Murdoch, Western Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Belumosudil
| DRUG: Belumosudil
|
PLACEBO_COMPARATOR: Placebo
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Event-Free Survival (EFS) | from the date of randomization to the date of any predefined event, whichever occurs first | Until the end of the study (up to 5 years since first patient in). |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
modified Lee Symptom Scale (mLSS) | Proportion of participants who achieve a clinically relevant reduction in mLSS of at least 6 points from baseline (Only in participants at least 18 years of age) | Until the end of the study (up to 5 years since first patient in). |
overall response rate (ORR) | Proportion of participants who achieve an overall response (PR or CR) as per 2014 NIH consensus response criteria by 48 weeks and maintained the response for a duration of at least 6 months | Until the end of the study (up to 5 years since first patient in). |
rate of corticosteroid withdrawal | Proportion of participants who successfully discontinue all systemic corticosteroids for cGVHD for at least 30 days before the occurrence of cGVHD progression, or start of a new systemic treatment for cGVHD, relapse or recurrence of the underlying disease, or unacceptable toxicity | Until the end of the study (up to 5 years since first patient in). |
Overall response rate (ORR) | Proportion of participants who achieve an overall response (CR or PR) as per 2014 NIH consensus response criteria at any time before the start of new systemic treatment for cGVHD | Until the end of the study (up to 5 years since first patient in). |
ORR by 24 weeks | Proportion of participants who achieve an overall response (CR or PR) as per 2014 NIH consensus response criteria by 24 weeks (Cycle 7 Day 1) before the start of new systemic treatment for cGVHD | Until the end of the study (up to 5 years since first patient in). |
Duration of response (DOR) | Time from the date of the first response to the date of cGVHD progression as defined by 2014 NIH consensus response criteria, start of new systemic treatment for cGVHD, or death, whichever occurs first. DOR is determined only for participants who achieved overall response (PR or CR) as per 2014 NIH consensus response criteria | Until the end of the study (up to 5 years since first patient in). |
Dose reduction in corticosteroid | Proportion of participants with a reduction in daily corticosteroid dose | Until the end of the study (up to 5 years since first patient in). |
Failure Free Survival (FFS) | Failure Free Survival (FFS) is defined as the time from the date of randomization to the date of start of a new systemic treatment for cGVHD, relapse or recurrence of the underlying disease, or death, whichever occurs first. | Until the end of the study (up to 5 years since first patient in). |
Change in patient reported outcome (PRO) | Change from baseline in Patient-Reported Outcomes Measurement Information System Global Health (PROMIS-GH) (Only in participants at least 18 years of age) and the European Quality of Life Group Questionnaire with 5 Dimensions and 5 Levels (EQ5D5L) | Until the end of the study (up to 5 years since first patient in). |
Number of participants with treatment-emergent adverse events [TEAEs], serious TEAEs, and adverse events of special interest (AESIs) | Not Specified | Until the end of the study (up to 5 years since first patient in). |
Overall survival | The time from the date of randomization to the date of death due to any cause | Until the end of the study (up to 5 years since first patient in). |
Frequently Asked Questions
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