Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-02 @ 9:23 AM
Study NCT ID:
NCT07132567
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009182', 'term': 'Mycosis Fungoides'}, {'id': 'D012751', 'term': 'Sezary Syndrome'}], 'ancestors': [{'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549035', 'term': 'mogamulizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2025-07-22', 'studyFirstSubmitQcDate': '2025-08-17', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety (Special situation, adverse event, symptom, or disease occurring during treatment with Poteligeo)', 'timeFrame': 'From first administration of Poteligeo through 90 days after the last dose', 'description': 'Number of participants who experience any adverse event or special situation during Poteligeo treatment and up to 90 days after the last dose, as recorded in CRFs based on medical examinations or spontaneous reports.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to after 8th administration in Global Response Score (GRS)', 'timeFrame': 'Baseline (Day 1, prior to first dose) and Week 24 (after completion of 8th administration)', 'description': 'Change in Global Response Score (GRS) from baseline (before first dose) to after the 8th administration, assessing skin, nodes, blood, and viscera. CR/PR = Effective; SD/PD/Relapse = Ineffective.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Poteligeo', 'mycosis fungoides', 'Sezary syndrome'], 'conditions': ['Mycosis Fungoides', 'Sezary Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this surveillance is to assess the safety and efficacy of Poteligeo Inj. 20 mg (mogamulizumab) in routine clinical settings.', 'detailedDescription': 'This post-marketing surveillance (PMS) is designed as an all-case investigation in accordance with the Korean Ministry of Food and Drug Safety (MFDS) re-examination requirements. It targets adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy and are treated with mogamulizumab (POTELIGEO® Injection 20 mg) under the approved indication in Korea.\n\nPrimary Objective: To assess the safety of mogamulizumab for patients treated under the approved indication in Korea.\n\nSecondary Objective: To assess the effectiveness of mogamulizumab for patients treated under the approved indication in Korea.\n\nExploratory Objective: To perform additional subgroup and exploratory analyses of effectiveness, including evaluation in special populations such as elderly patients, patients with renal or hepatic impairment, and those with a history of hematopoietic stem cell transplantation, treated under the approved indication in Korea'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A person who has Mycosis fungoides and sezary syndrome.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults 19 years of age or older\n2. Individuals who are confirmed to have received administration of the study drug for the purpose of "the treatment for adult patients with fungoidal granuloma or Sezary syndrome who have received one or more systemic therapies," or who are considered to require administration of the study drug in the investigator\'s opinion\n3. Individuals who (or whose legally acceptable representatives) signed the Consent to Use of Personal Information of their own free will for participation in this use-result surveillance\n\nExclusion Criteria\n\n1. Patients with hypersensitivity to any ingredients of this drug\n2. Patients who intend to use this drug for non-approved indications\n3. Patients who participated in a pre-market clinical trial of the study drug and received administration of the study drug'}, 'identificationModule': {'nctId': 'NCT07132567', 'briefTitle': 'Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance', 'orgStudyIdInfo': {'id': 'Poteligeo PMS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Poteligeo 20mg', 'type': 'DRUG', 'otherNames': ['Mogamulizumab'], 'description': 'Poteligeo 20mg'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49267', 'city': 'Busan', 'state': 'Busan Metropolitan City', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kosin University Gospel Hospital hemato oncology', 'role': 'CONTACT', 'email': 'hs52silver@gmail.com', 'phone': '+82-51-990-6770'}, {'name': 'Ho Sup Lee', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kosin University Gospel Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Seoul', 'status': 'TERMINATED', 'country': 'South Korea', 'facility': 'Chung-Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ewha Womans University Mokdong Hospital hemato oncology', 'role': 'CONTACT', 'email': 'yeungchul@ehwa.ac.kr', 'phone': '+82-2-2650-5063'}, {'name': 'Yeungchul Moon', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ewha Womans University Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Samsung Medical Center hemato oncology', 'role': 'CONTACT', 'email': 'kstwoh@skku.edu', 'phone': '+82 2-3410-6856'}, {'name': 'SeokJin Kim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seoul National University Hospital hemato-oncology', 'role': 'CONTACT', 'email': 'ihkimmd@snu.ac.kr', 'phone': '+82 2 2072 0834'}, {'name': 'Kim in ho', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seoul National University Hospital hemato-oncology', 'role': 'CONTACT', 'email': 'go01@snu.ac.kr', 'phone': '+82 2-2072-4990'}, {'name': 'Youngil Koh', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'HaeMi Park', 'role': 'CONTACT', 'email': 'haemi.park.m8@kyowakirin.com', 'phone': '+82-10-3378-3471'}], 'overallOfficials': [{'name': 'HaeMi Park', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kyowa Kirin Korea Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}