NCT06824103 Study of Efficacy and Safety of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft vs. Host Disease
| NCT ID | NCT06824103 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Graft vs. Host Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-09-09 |
| Primary Completion | 2029-05-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2025-09-09 with a primary completion date of 2029-05-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to assess the efficacy and safety of ruxolitinib in Chinese adult and pediatric participants aged 12 years or older with corticosteroid-refractory chronic graft vs. host disease (SR-cGvHD).
Eligibility Criteria
Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Male or female Chinese participants aged 12 or older at the time of informed consent * Able to swallow tablets.- Have undergone alloSCT from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative, and reduced intensity conditioning are eligible. * Evident myeloid and platelet engraftment: * Absolute neutrophil count (ANC) \>1,000/mm3 AND * Platelet count ≥25,000/mm3 Note: Use of growth factor supplementation and transfusion support is allowed during the trial, however, transfusion to reach a minimum platelet count for inclusion is not allowed during screening and at baseline. * Participants with clinically diagnosed cGvHD staging of moderate to severe according to NIH Consensus Criteria (Jagasia et al 2015) prior to Cycle 1 Day 1. * Moderate cGvHD: at least one organ (not lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1. * Severe cGvHD: at least 1 organ with a score of 3, or lung score of 2 or 3. * Participants currently receiving systemic corticosteroids for the treatment of cGvHD for a duration of \< 12 months prior to Cycle 1 Day 1, and have a confirmed diagnosis of corticosteroid refractory cGvHD defined per 2014 NIH consensus criteria (Martin et al 2015) irrespective of the concomitant use of a calcineurin inhibitor, as follows: * A lack of response or disease progression after administration of minimum prednisone 1 mg/kg/day for at least 1 week (or equivalent) OR * Disease persistence without improvement despite continued treatment with prednisone at \>0.5 mg/kg/day or 1 mg/kg/every other day for at least 4 weeks (or equivalent) OR * Increase to prednisone dose to \>0.25 mg/kg/day after two unsuccessful attempts to taper the dose (or equivalent) * Participants has Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Exclusion Criteria: For a full list of exclusion criteria, refer to Section 5.2. Key exclusion criteria include * Participants who have received two or more systemic treatments for cGvHD in addition to corticosteroids ± CNI for cGvHD. * Participants who have received ROCK2 inhibitors for cGvHD. * Participants that transition from active aGvHD to cGvHD without tapering off corticosteroids ± CNI and any systemic treatment Note: Participants receiving up to 30 mg by mouth once a day of hydrocortisone (i.e., physiologic replacement dose) of corticosteroids are allowed. * Participants who were treated with prior JAK inhibitors for aGvHD; except when the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks prior to Cycle 1 Day 1. * Failed prior alloSCT within the past 6 months from Cycle 1 Day 1. * Participants with relapsed primary malignancy, or who have been treated for relapse after the alloSCT was performed. * SR-cGvHD occurring after a non-scheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence. Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible. Other protocol-defined inclusion/exclusion may apply.
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT06824103 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 100 Years, studying Graft vs. Host Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06824103 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06824103 currently recruiting?
Yes, NCT06824103 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT06824103 trial being conducted?
This trial is being conducted at Hefei, China, Guangzhou, China, Guangzhou, China, Nanning, China and 11 additional locations.
Who is sponsoring the NCT06824103 clinical trial?
NCT06824103 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 50 participants.