Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-29 @ 8:35 PM
Study NCT ID:
NCT05198557
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-08
First Post:
2022-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MT-0551 in Patients With Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000609745', 'term': 'inebilizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2022-01-06', 'studyFirstSubmitQcDate': '2022-01-06', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the mRTSS up to the end of the long-term extension period', 'timeFrame': 'baseline, RCP 4, 12, 26, OLP 4,12, 26, the long-term extension period 26, 52, 78, 104 weeks'}], 'secondaryOutcomes': [{'measure': 'Pulmonary function tests: Change from baseline in the percent predicted forced vital capacity (%FVC) and percent predicted diffusing capacity of the lung carbon monoxide (%DLco)', 'timeFrame': 'Baseline to at least 52 weeks or early termination'}, {'measure': 'Pulmonary function tests: Percentage change from baseline in the %FVC and %DLco', 'timeFrame': 'Baseline to at least 52 weeks or early termination'}, {'measure': 'Change from baseline in the mRTSS', 'timeFrame': 'Baseline to at least 52 weeks or early termination'}, {'measure': 'Composite response index in diffuse cutaneous systemic sclerosis', 'timeFrame': 'Week 26 to at least 52 weeks or early termination'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Sclerosis']}, 'descriptionModule': {'briefSummary': 'The study will verify the superiority of MT-0551 to placebo at 26 weeks after treatment initiation in systemic sclerosis (SSc) patients using the modified Rodnan Total Skin thickness Score (mRTSS) as a measure of skin thickening. The safety and pharmacokinetics will also be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdditional screening criteria check may apply for qualification:\n\n1. ACR/European League Against Rheumatism (EULAR) criteria (2013) systemic sclerosis (SSc) diagnostic criteria satisfied.\n2. Skin thickening score based on the mRTSS between 10 and 22 inclusive.\n\nExclusion Criteria:\n\nAdditional screening criteria check may apply for qualification:\n\n1. Pulmonary hypertension associated with SSc.\n2. Presence of a serious, SSc-related concurrent illness other than interstitial pneumonia.\n3. Finding of inadequate respiratory reserve capacity.\n4. Past history of rituximab, blinatumomab, obinutuzumab, or ofatumumab.\n5. Presence of a clinically significant active infection requiring antimicrobial therapy.\n6. A past history of cancer.\n7. Past history of a recurrent, clinically significant infection.\n8. Past history of severe allergy or anaphylactic reaction to a biologic drug product.\n9. Treatment with live vaccine within a certain period (inactivated vaccine is acceptable).'}, 'identificationModule': {'nctId': 'NCT05198557', 'briefTitle': 'A Study of MT-0551 in Patients With Systemic Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'Phase 3 Study of MT-0551 in Patients With Systemic Sclerosis (Placebo-Controlled Double-Blind Study)', 'orgStudyIdInfo': {'id': 'MT-0551-A-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MT-0551 group', 'description': 'Participants will receive intravenous (IV) inebilizumab on Day 1 and Day 15 of randomized controlled period (RCP). The participants who entered open label period (OLP) will receive IV inebilizumab on Day 1 and IV placebo on Day 15 of OLP and will be followed by IV inebilizumab every 26 weeks.', 'interventionNames': ['Drug: Inebilizumab', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Participants will receive IV placebo on Day 1 and Day 15 of the RCP. The participants who entered OLP will receive IV inebilizumab on both Day 1 and Day 15 in OLP and will be followed by IV inebilizumab every 26 weeks.', 'interventionNames': ['Drug: Inebilizumab', 'Drug: Placebo']}], 'interventions': [{'name': 'Inebilizumab', 'type': 'DRUG', 'otherNames': ['MT-0551'], 'description': 'Participants will receive IV inebilizumab.', 'armGroupLabels': ['MT-0551 group', 'Placebo group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive IV placebo matched to inebilizumab.', 'armGroupLabels': ['MT-0551 group', 'Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '910-1193', 'city': 'Yoshida-gun', 'state': 'Fukui', 'country': 'Japan', 'facility': 'University of Fukui Hospital'}, {'zip': '920-8641', 'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Kanazawa University Hospital', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '216-8511', 'city': 'Kawasaki-shi', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'St. Marianna University Hospital'}, {'zip': '113-8655', 'city': 'Bunkyo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'The University of Tokyo Hospital'}], 'overallOfficials': [{'name': 'General Manager', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanabe Pharma Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}