BridgeMD
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.
EU CTIS ID: 2023-505394-32-00
What this study is testing
Demonstrate the superiority of belumosudil in combination with prednisone vs placebo in combination with prednisone in Event-Free Survival (EFS)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 require systemic treatment with corticosteroids for cGVHD
- Participants who have not received any prior systemic treatment for cGVHD (including ECP)
- If participants are receiving other immunosuppressive agents for the prophylaxis or treatment of acute GVHD, the dose should be under the threshold pre-defined in protocol
- For adult participants, the body weight should be ≥40 kg. For adolescent participants, the body weight should be ≥30 kg.
You likely can't join if
- Active uncontrolled cytomegalovirus (CMV) and Epstein-Barr virus (EBV) infection. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of infection worsening are present according to Investigator’s judgement
- Received any investigational agents, or any investigational device or procedure, or prohibited therapy for this study within 28 days or 5 elimination half-lives prior to randomization, whichever is longer
- - Absolute neutrophil count (ANC) <0.5 x 109/L. The use of granulocyte-colony stimulating factor (G-CSF) is not allowed to reach this level during screening
- Karnofsky (if aged ≥16 years)/Lansky (if aged <16 years) Performance Score of < 60
- - Platelets <25 x 109/L. Platelet transfusion is not allowed within 3 days before the screening hematological test
- Any active, uncontrolled infections assessed to be clinically significant by the Investigator
See the full eligibility criteria
Who can join
- 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 require systemic treatment with corticosteroids for cGVHD
- Participants who have not received any prior systemic treatment for cGVHD (including ECP)
- If participants are receiving other immunosuppressive agents for the prophylaxis or treatment of acute GVHD, the dose should be under the threshold pre-defined in protocol
- For adult participants, the body weight should be ≥40 kg. For adolescent participants, the body weight should be ≥30 kg.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Participants or their legally authorized representative must be capable of giving signed informed consent
What rules you out
- Active uncontrolled cytomegalovirus (CMV) and Epstein-Barr virus (EBV) infection. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of infection worsening are present according to Investigator’s judgement
- Received any investigational agents, or any investigational device or procedure, or prohibited therapy for this study within 28 days or 5 elimination half-lives prior to randomization, whichever is longer
- - Absolute neutrophil count (ANC) <0.5 x 109/L. The use of granulocyte-colony stimulating factor (G-CSF) is not allowed to reach this level during screening
- Karnofsky (if aged ≥16 years)/Lansky (if aged <16 years) Performance Score of < 60
- - Platelets <25 x 109/L. Platelet transfusion is not allowed within 3 days before the screening hematological test
- Any active, uncontrolled infections assessed to be clinically significant by the Investigator
- Estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73 m2 using the MDRD-4 variable formula (if aged ≥18 years) or using the Bedside Schwartz formula (if aged <18 years)
- - Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3 x ULN without liver cGVHD or>5 × ULN with liver) cGVHD
- Total bilirubin >1.5 × (ULN) (>3 × ULN if Gilbert syndrome)
- Participant has forced expiratory volume in 1 second (FEV1) of predicted ≤39% or has lung score of 3 according to NIH consensus diagnostic and staging criteria (2014)
- History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study (such as malabsorption syndromes, poorly controlled psychiatric disease or coronary artery disease)
- Diagnosed or treated for another malignancy other than the underlying disease allogeneic HCT was indicated for, within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low risk prostate cancer after curative therapy
- Known history of human immunodeficiency virus (HIV)
- Active viral disease including hepatitis B virus (HBV) or hepatitis C virus (HCV)
- - Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of progressive or relapsed underlying disease after the most recent allogeneic HCT
- Post-transplant lymphoproliferative disease within 4 weeks prior to randomization
- Unable to swallow tablets
- Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
- Female participants who are pregnant or breastfeeding
- Unable to tolerate a prednisone equivalent dose of corticosteroids ≥ 1 mg/kg/day
- Participant has had previous exposure to belumosudil.
- Received any previous systemic treatment for cGVHD with the following exception: Corticosteroids for cGVHD received within 7 days prior to the planned administration of IMP only if in the interest of participant.
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- United States
- Canada
- Korea, Republic of
- Hong Kong
- Brazil
- China
- United Kingdom
- Turkey
- Australia
- Israel
- Saudi Arabia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; United States; Canada; Korea, Republic of; Hong Kong; Brazil and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.