Nctid:
NCT06616415
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000092122", "term"=>"Bronchiolitis Obliterans Syndrome"}, {"id"=>"D000006086", "term"=>"Graft vs Host Disease"}], "ancestors"=>[{"id"=>"D000007154", "term"=>"Immune System Diseases"}, {"id"=>"D000092124", "term"=>"Organizing Pneumonia"}, {"id"=>"D000001989", "term"=>"Bronchiolitis Obliterans"}, {"id"=>"D000001988", "term"=>"Bronchiolitis"}, {"id"=>"D000001991", "term"=>"Bronchitis"}, {"id"=>"D000001982", "term"=>"Bronchial Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000008173", "term"=>"Lung Diseases, Obstructive"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}], "browseLeaves"=>[{"id"=>"M9189", "name"=>"Graft vs Host Disease", "asFound"=>"Graft Versus Host Disease", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M5264", "name"=>"Bronchiolitis", "relevance"=>"LOW"}, {"id"=>"M2893", "name"=>"Bronchiolitis Obliterans Syndrome", "asFound"=>"Chronic Graft Versus Host Disease", "relevance"=>"HIGH"}, {"id"=>"M5265", "name"=>"Bronchiolitis Obliterans", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M13904", "name"=>"Pneumonia", "relevance"=>"LOW"}, {"id"=>"M2894", "name"=>"Organizing Pneumonia", "relevance"=>"LOW"}, {"id"=>"M5267", "name"=>"Bronchitis", "relevance"=>"LOW"}, {"id"=>"M5258", "name"=>"Bronchial Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M11170", "name"=>"Lung Diseases, Obstructive", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "asFound"=>"Chronic Graft Versus Host Disease", "relevance"=>"HIGH"}, {"id"=>"T2832", "name"=>"Homologous Wasting Disease", "asFound"=>"Graft Versus Host Disease", "relevance"=>"HIGH"}, {"id"=>"T871", "name"=>"Bronchiolitis Obliterans", "relevance"=>"LOW"}, {"id"=>"T872", "name"=>"Bronchiolitis Obliterans Organizing Pneumonia", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"C000718240", "term"=>"Belumosudil"}], "ancestors"=>[{"id"=>"D000047428", "term"=>"Protein Kinase Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M354013", "name"=>"Belumosudil", "asFound"=>"Timely", "relevance"=>"HIGH"}, {"id"=>"M9047", "name"=>"Glucocorticoids", "relevance"=>"LOW"}, {"id"=>"M25820", "name"=>"Protein Kinase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>6}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-07", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-04-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-27", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-04-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Plasma concentrations of belumosudil at specified time points", "timeFrame"=>"At Day 1 and Day 29(±3)"}], "secondaryOutcomes"=>[{"measure"=>"Overall response rate (ORR)", "timeFrame"=>"Up to 18 month", "description"=>"Overall response rate (ORR, including complete response \\[CR\\] and partial response \\[PR\\]), which will be assessed by the investigator according to the NIH Consensus Criteria (2014) at any time before the start of new systemic treatment for cGVHD."}, {"measure"=>"Duration of response (DoR)", "timeFrame"=>"Up to 18 month", "description"=>"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."}, {"measure"=>"System organ response rate", "timeFrame"=>"Up to 18 month", "description"=>"System organ response rate: proportion of participants who achieve an overall response (CR or PR) for each of the nine individual organs (Skin, Eyes, Mouth, Esophagus, Upper GI, Lower GI, Liver, Lungs, and Joints and fascia) as per 2014 NIH consensus response criteria at any time before the start of new systemic treatment for cGVHD"}, {"measure"=>"Number and proportion of participants with dose reduction in corticosteroid during the treatment period", "timeFrame"=>"Up to 18 month"}, {"measure"=>"Failure-free survival (FFS)", "timeFrame"=>"Up to 18 month", "description"=>"Failure-free survival (FFS): time from the date of the first administration of IMP to 1) the date of initiation of new systemic treatment for cGVHD, or 2) date of death, or 3) date of recurrent underlying disease, whichever occurs first"}, {"measure"=>"Overall survival (OS)", "timeFrame"=>"Up to 18 month", "description"=>"Overall survival (OS): time from the date of the first administration of IMP to the date of death due to any cause"}, {"measure"=>"Change in cGVHD severity based on physician-reported overall cGVHD activity", "timeFrame"=>"Up to 18 month"}, {"measure"=>"Change in symptom activity assessed based on patient-reported cGVHD activity", "timeFrame"=>"Up to 18 month"}, {"measure"=>"Modified Lee cGVHD Symptom Scale change", "timeFrame"=>"Up to 18 month", "description"=>"The scale contains 30 items grouped in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological). Patients report how \"bothered\" they feel about each symptom using a five-point Likert scale from \"not at all\" (0) to \"extremely\" (4). A higher score indicating worse symptoms."}, {"measure"=>"Number and proportion of participants with calcineurin inhibitor (CNI) dose reduction or discontinuation during the treatment period", "timeFrame"=>"Up to 18 month"}, {"measure"=>"Number of participants with treatment-emergent adverse events (TEAEs), serious TEAEs, and adverse events of special interest (AESIs)", "timeFrame"=>"Up to 18 month"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Chronic Graft Versus Host Disease"]}, "descriptionModule"=>{"briefSummary"=>"This is a single group, Phase 4, single-arm post-marketing study for treatment.\n\nThe purpose of this study is to verify the pharmacokinetics, efficacy, and safety of belumosudil mesylate tablets in Chinese adolescent participants (aged from 12 to less than 18) with cGVHD who have had an inadequate response to glucocorticoids or other systemic therapies.\n\nParticipants will receive treatment with belumosudil tablets 200 mg once daily in 28-day cycles during the study."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"17 years", "minimumAge"=>"12 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Participant must be 12 to less than 18 years of age at the time of signing the informed consent.\n* Participant has undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n* Has active moderate to severe cGVHD.\n* Has received at least one line of prior systemic therapy for cGVHD.\n* Participant must receive a corticosteroid therapy for cGVHD with a stable dose for at least 2 weeks prior to the first dose of the IMP.\n* Has a Lansky-Play performance score of ≥60.\n* Participants should have an expected survival of longer than 6 months.\n* Body weight of 30 kg and above.\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* The participant or their legally authorized representative (LAR) must be capable of giving signed informed consent.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Recurrence of hematologic neoplasms (according to the corresponding criteria for recurrence of primary hematologic neoplasms) or post-transplant lymphoproliferative disease at screening.\n* Received investigational systemic therapy for cGVHD within 28 days prior to enrollment, unless the prior treatment had been washed out for at least 28 days or 5 half-lives prior to enrollment, whichever is shorter.\n* Absolute neutrophil count (ANC) \\<1.0 × 10\\^9/L.\n* Platelet count \\<50 × 10\\^9/L.\n* Alanine aminotransferase (ALT) \\>3× the upper limit of normal (ULN), aspartate aminotransferase (AST) \\>3 × ULN.\n* Total bilirubin (TBIL) \\>1.5 × ULN (\\>3 ULN if Gilbert's syndrome).\n* Estimated Glomerular Filtration Rate (eGFR) \\<30 mL/min/1.73 m\\^2 using the revised Bedside Schwartz formula . Revised Schwartz equation: CrCl (mL/min/1.73 m\\^2) = 0.413 × (height \\[in cm\\])/Creatinine (in mg/dL) at screening visit.\n* 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."}, "identificationModule"=>{"nctId"=>"NCT06616415", "briefTitle"=>"A Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belumosudil in Chinese Adolescents With cGVHD Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Sanofi"}, "officialTitle"=>"A Multicenter, Open-label, Single-arm, Phase 4 Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belumosudil Mesylate Tablets in Chinese Adolescents (Aged From 12 to Less Than 18 Years) With Chronic Graft-versus-host Disease (cGVHD) Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies", "orgStudyIdInfo"=>{"id"=>"ACT18369"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Belumosudil", "description"=>"Participants will receive belumosudil 200 mg tablets orally QD in 28-day cycles until clinically significant progression of cGVHD", "interventionNames"=>["Drug: Belumosudil"]}], "interventions"=>[{"name"=>"Belumosudil", "type"=>"DRUG", "otherNames"=>["SAR445761/ KD025", "Rezurock"], "description"=>"Pharmaceutical form: Tablet Route of administration: Oral", "armGroupLabels"=>["Belumosudil"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Trial Transparency email recommended (Toll free for US & Canada)", "role"=>"CONTACT", "email"=>"Contact-US@sanofi.com", "phone"=>"800-633-1610", "phoneExt"=>"option 6"}], "overallOfficials"=>[{"name"=>"Clinical Sciences & Operations", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Sanofi"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"YES", "description"=>"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Sanofi", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
