Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-02-09 @ 11:45 AM
Study NCT ID:
NCT05504694
Status:
UNKNOWN
Last Update Posted:
2022-08-17
First Post:
2022-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ofatumumab in AQP4-IgG Seropositive NMOSD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009471', 'term': 'Neuromyelitis Optica'}], 'ancestors': [{'id': 'D009188', 'term': 'Myelitis, Transverse'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009902', 'term': 'Optic Neuritis'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C527517', 'term': 'ofatumumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-16', 'studyFirstSubmitDate': '2022-08-16', 'studyFirstSubmitQcDate': '2022-08-16', 'lastUpdatePostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in annual relapse rate (ARR) at last follow-up visit', 'timeFrame': 'baseline, 12 months', 'description': 'Pre-treatment ARR was determined at baseline by the total number of attacks divided by disease course from onset to baseline; post-treatment ARR is determined at 12 months after treatment by the number of relapses divided by 12 months.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Expanded Disability Status Scale (EDSS) score', 'timeFrame': 'baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'Patients are followed up and EDSS score is determined. In general, the minimum and maximum scores of EDSS are 0 and 10, respectively, with higher scores meaning a worse outcome.'}, {'measure': 'Change from baseline in lesion burden on MRI T2-weighted images', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'MRI is conducted to measure the lesion burden on T2-weighted images.'}, {'measure': 'Change from baseline in optic coherence tomography (OCT) measures', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'OCT is done to measure peripapillary retinal nerve fiber layer (RNFL) thickness, macular ganglion cell-inner plexiform layer (GCIPL) thickness, and macular inner nuclear layer (INL) thickness.'}, {'measure': 'Change from baseline in the frequencies of circulating B cell subsets', 'timeFrame': 'baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, 12 months', 'description': 'Circulating B cell monitoring is conducted to evaluate the effectiveness of B-cell-depletion therapy. FACS is used to measure the frequencies of CD19+ B cells, CD19+CD27+ memory B cells, and CD19+CD38+CD27+ plasmablasts.'}, {'measure': 'Change from baseline in immune landscape', 'timeFrame': 'baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, 12 months', 'description': 'The dynamic changes of immune cells and cytokines are monitored, such as Th1 cells, Th2 cells, Th17 cells, NK cells, IL-1β, IL-2, IL-4, etc.'}, {'measure': 'Biochemical indicators monitoring', 'timeFrame': 'baseline, 1 month, 3 months, 6 months, 9 months, 12 months', 'description': 'Blood routine test, liver and kidney function, immunoglobulins, complement, and serum AQP4-IgG titer.'}, {'measure': 'Assessment of functional questionnaire', 'timeFrame': 'baseline, 1 month, 3 months, 6 months, 9 months, 12 months', 'description': 'SF-36, Functional Assessment of Chronic Illness Therapy (FACIT), EuroQol Health State (EQ-5D), Visual Analogue Pain Scale (VAPS), Timed 25-foot Walk Test, etc.'}, {'measure': 'Adverse events', 'timeFrame': '1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, 12 months', 'description': 'Ofatumumab-related adverse events (AEs) are evaluated and the rate of AEs is recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuromyelitis Optica Spectrum Disorder', 'Aquaporin 4', 'Ofatumumab'], 'conditions': ['Neuromyelitis Optica Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'This is an open-label, single-arm, multicentre prospective pilot study to assess the efficacy and safety of ofatumumab in patients with AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) in China.', 'detailedDescription': 'Neuromyelitis optica spectrum disorder (NMOSD) is a rare but severe demyelinating disorder that affects mainly adult patients. It is associated with a pathological B cell-mediated humoral immune response against the aquaporin-4 (AQP4) water channel. Monoclonal antibodies against CD20 have been shown to be effective for prevention of relapses in patients with NMOSD, and therefore been recommended as first-line therapy for this disorder. Ofatumumab (OFA), a fully humanized anti-CD20 monoclonal antibody, has been approved for multiple sclerosis treatment. However, prospective multicenter studies are needed to determine the efficacy and safety of ofatumumab in treating NMOSD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of NMOSD according to the 2015 International Panel Diagnostic Criteria for NMOSD with AQP4-IgG.\n* Clinical evidence of at least 2 relapses (including first attack) in past 24 months with at least 1 relapse occurring in the preceding 12 months.\n* Adults aged ≥18 years old.\n* Expanded disability status scale (EDSS) score between 0 and 7.5 (inclusive).\n* Provision of written informed consent to participate in this study.\n* Only oral corticosteroids were permitted at screening (≤10mg equivalent per day), which should be terminated within one month.\n* Effective contraception was used for female patients with fertility during the treatment or at least 3 months after stopping medication.\n\nExclusion Criteria:\n\n* Progressive neurological deterioration unrelated to relapses of NMOSD, or presence of neurological findings suspected with PML.\n* Pregnant or breastfeeding patients and those with family planning during the study period.\n* Patients participating in any other clinical therapeutic study at the screening or within 30 days of screening.\n* Patients with splenectomy or history of no spleen, and those with planned surgery (excluding minor surgery) during the study period.\n* Presence of uncontrolled severe concurrent diseases; long-term glucocorticoids or immunosuppressants use due to other autoimmune diseases, or presence of other chronic diseases that cannot receiving immunosuppression.\n* Active infection at within 4 weeks before baseline.\n* Positive for HBV or HCV.\n* Evidence of latent or active tuberculosis (TB).\n* Have received any live or live-attenuated vaccine within 6 weeks before baseline.\n* History of malignancy in past 5 years, including solid tumor, malignant hematopathy and carcinoma in situ.\n* History of severe allergic reactions to biological agents.\n* Inability to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT05504694', 'briefTitle': 'Ofatumumab in AQP4-IgG Seropositive NMOSD', 'organization': {'class': 'OTHER', 'fullName': 'Tang-Du Hospital'}, 'officialTitle': 'Efficacy and Safety of Ofatumumab in AQP4-IgG Seropositive NMOSD: an Open-label, Single-arm, Multicentre Prospective Pilot Study', 'orgStudyIdInfo': {'id': 'K202206-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ofatumumab', 'description': 'The enrolled patients will receive ofatumumab (20 mg/0.4 ml) subcutaneously administered at baseline, Day 7, Day 14 and monthly thereafter. Patients will receive ofatumumab therapy for a total of 48 weeks.', 'interventionNames': ['Drug: Ofatumumab']}], 'interventions': [{'name': 'Ofatumumab', 'type': 'DRUG', 'otherNames': ['Arzerra'], 'description': "The enrolled patients will receive ofatumumab (20 mg/0.4 ml) subcutaneously administered at baseline, Day 7, Day 14 and monthly thereafter. Patients will receive ofatumumab therapy for a total of 48 weeks.\n\nThe first 4 infusions will be administered at study center site; subsequent infusions will be given in the patient's home with a nurse online interview to administer the infusion.", 'armGroupLabels': ['Ofatumumab']}]}, 'contactsLocationsModule': {'locations': [{'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Guo, M.D.', 'role': 'CONTACT', 'email': 'guojun_81@163.com', 'phone': '86-29-8477 8844'}, {'name': 'Yan Jia, M.S.', 'role': 'CONTACT', 'email': 'neurologist_jiayan@163.com', 'phone': '86-29-8471 7483'}, {'name': 'Jun Guo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tangdu Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Jun Guo, M.D.', 'role': 'CONTACT', 'email': 'guojun_81@163.com', 'phone': '86-29-8477 8844'}, {'name': 'Yan Jia, M.S.', 'role': 'CONTACT', 'email': 'neurologist_jiayan@163.com', 'phone': '86-29-8471 7483'}], 'overallOfficials': [{'name': 'Jun Guo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tang-Du Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "Henan Provincial People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Neurology', 'investigatorFullName': 'Jun Guo, MD', 'investigatorAffiliation': 'Tang-Du Hospital'}}}}