Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:02 AM
Study NCT ID:
NCT07429266
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011087', 'term': 'Polycythemia Vera'}], 'ancestors': [{'id': 'D019046', 'term': 'Bone Marrow Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2031-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-02-18', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants with Absence of Phlebotomy Eligibility', 'timeFrame': 'Week 20 through Week 32', 'description': 'Response is defined as absence of phlebotomy eligibility.'}], 'secondaryOutcomes': [{'measure': 'Number of Phlebotomies', 'timeFrame': 'Week 0 through Week 32'}, {'measure': 'Percentage of Participants with Hct Control', 'timeFrame': 'Week 0 to Week 32', 'description': 'Defined as all local laboratory Hct \\<45% without phlebotomy.'}, {'measure': 'Change from Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Total T-score', 'timeFrame': 'Baseline, Week 32'}, {'measure': 'Change from Baseline in Myelofibrosis Symptom Assessment Form (MFSAF) Total Symptom Score (TSS)', 'timeFrame': 'Baseline, Week 32'}, {'measure': 'Percentage of Participants with Absence of Phlebotomy Eligibility', 'timeFrame': 'Week 20 through Week 52', 'description': 'Response is defined as absence of phlebotomy eligibility.'}, {'measure': 'Number of Phlebotomies', 'timeFrame': 'Week 0 through Week 52'}, {'measure': 'Percentage of Participants with Hct Control', 'timeFrame': 'Week 0 through Week 52', 'description': 'Defined as all local laboratory Hct \\<45% without phlebotomy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycythemia Vera']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of sapablursen when added on to current standard of care (SOC) for Polycythemia Vera (PV) therapy. The study will be conducted in three sequential parts (Part 1a blinded treatment, Part 1b open-label treatment, \\& Part 2 long-term extension). Participants may receive treatment for up to 156 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Meet revised 2022 World Health Organization (WHO) and 2022 International Consensus Classification criteria for the diagnosis of PV.\n2. Participants must be phlebotomy-dependent.\n3. Hct less than (\\<) 45% at study start.\n4. Participants receiving Cytoreduction therapy (CRT) must be on a stable regimen at study start.\n5. Adequate organ function and electrolytes.\n\nExclusion Criteria:\n\n1. Prior treatment of PV with Transmembrane serine protease 6 (TMPRSS6) inhibitors, including sapablursen, or hepcidin mimetics.\n2. Clinically significant thrombosis (eg, myocardial infarction, stroke, deep vein thrombosis or splenic vein thrombosis) within 1 month prior to randomization.\n3. Participants who require phlebotomy at Hct levels \\<45%.\n4. Meet the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment.\n5. Any serious or unstable medical condition or uncontrolled psychiatric condition that would interfere with their ability to comply with study requirements.'}, 'identificationModule': {'nctId': 'NCT07429266', 'briefTitle': 'A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera', 'orgStudyIdInfo': {'id': 'ONO-0530-03-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sapablursen', 'description': 'Sapablursen (32 Weeks) - Sapablursen (124 Weeks Open-label)', 'interventionNames': ['Drug: Sapablursen']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Placebo (32 Weeks) - Sapablursen (124 Weeks Open-label)', 'interventionNames': ['Drug: Sapablursen', 'Drug: Placebo']}], 'interventions': [{'name': 'Sapablursen', 'type': 'DRUG', 'otherNames': ['ONO-0530', 'ISIS 702843'], 'description': 'Administered subcutaneously (SC)', 'armGroupLabels': ['Placebo', 'Sapablursen']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Clinical Team', 'role': 'CONTACT', 'email': 'clinicaltrials@deciphera.com', 'phone': '888-724-3274'}], 'overallOfficials': [{'name': 'Clinical Team', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Deciphera Pharmaceuticals, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Deciphera Pharmaceuticals, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}