Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06143891 | 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. | PHASE3 | ACTIVE NOT_RECRUITING | 260 | — | — | Jan 23, 2024 | Sep 29, 2028 | Oct 14, 2025 | 151 | United States, Argentina +22 |
| NCT07116031 | A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK) | PHASE2 | RECRUITING | 37 | — | — | Dec 2, 2025 | Feb 28, 2031 | Jun 5, 2026 | 33 | United States, Belgium +11 |
| NCT06046248 | Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease | PHASE2 | RECRUITING | 25 | — | — | Jan 29, 2024 | Dec 31, 2027 | Apr 20, 2026 | 1 | United States |
| NCT05996627 | Belumosudil for the Pre-emptive Treatment of Patients With Chronic Graft Versus Host Disease | PHASE2 | RECRUITING | 82 | — | — | Dec 6, 2023 | Nov 30, 2028 | Jun 4, 2026 | 5 | United States |
From the date of randomization to the date of any predefined event, whichever occurs first
PK parameter (AUC at steady state)
Proportion of participants who achieve an overall response (partial response \[PR\] or complete response \[CR\]) with up to 24 weeks of therapy (i.e. by the Week 25 or Cycle 7 Day 1 visit whichever is first), as defined by the National Institute of Health (NIH) Consensus response criteria
Systemic therapies include any systemic agent given for a cGVHD indication, including extracorporeal photopheresis. Will use Gray's test. Point estimates of new systemic immunosuppressive use will be obtained using cumulative incidence estimates.
| Arm | Type | Description |
|---|---|---|
| Belumosudil | EXPERIMENTAL | Participants will receive belumosudil 200 mg tablets per os(PO) once daily (QD) per 28-day cycles starting on Day 1 until discontinuation criteria are met or until end of study Note: 200mg two times a day (BID) is used in some cases, when the subject is taking a proton pump inhibitor or a strong CYP3A4 inducer) |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo tablets PO QD per 28-day cycles starting on Day 1 until discontinuation criteria are met or until end of study |
| Belumosudil Plus Rituximab | EXPERIMENTAL | Belumosudil plus Rituximab |
| Arm I (Belumosudil) | EXPERIMENTAL | Patients receive belumosudil PO QD or BID if taken with strong CYP3A inducers or proton pump inhibitors for days 1 through 28 of each cycle. Cycles repeat every 28 days for a total of 11 cycles, followed by one cycle of tapering prior to discontinuation, in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on study. |
| Arm II (Placebo) | PLACEBO_COMPARATOR | Patients receive a placebo PO QD or BID if taken with strong CYP3A inducers or proton pump inhibitors for days 1 through 28 of each cycle. Cycles repeat every 28 days for a total of 11 cycles, followed by one cycle of tapering prior to discontinuation, in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on study. |
| Name | Type | Description |
|---|---|---|
| Belumosudil | DRUG | Pharmaceutical form:Tablet-Route of administration:oral |
| Placebo | DRUG | Pharmaceutical form:Table-Route of administration:oral |
| Prednisone | DRUG | Pharmaceutical form:Tablet-Route of administration:oral |
| Prednisolone | DRUG | Pharmaceutical form:Tablet-Route of administration:oral |
| Rituximab | DRUG | 375mg/m2 IV Q1 week x 4 weeks, then Q3 months x4 doses |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Electronic Health Record Review | OTHER | Ancillary studies |
| Placebo Administration | DRUG | Given PO |
Inclusion Criteria: * Patients must be at least 12 years of age inclusive, at the time of signing the informed consent * Participants who have undergone allogenic HCT with newly diagnosed moderate to severe cGVHD according to NIH consensus diagnosis and staging criteria (2014) * Participants who re...