Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-28 @ 6:42 PM
Study NCT ID:
NCT05145361
Status:
RECRUITING
Last Update Posted:
2025-08-17
First Post:
2021-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2021-11-21', 'studyFirstSubmitQcDate': '2021-12-02', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicity (DLT)', 'timeFrame': 'Up to 18 days.', 'description': 'Measurement of DLT in all subjects.'}, {'measure': 'Evaluate incidence of treatment-emergent adverse events [Safety and Tolerability].', 'timeFrame': 'Up to 1 year'}], 'secondaryOutcomes': [{'measure': 'Maximum serum concentration (Cmax) of B001.', 'timeFrame': 'Through study completion, up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of B001.'}, {'measure': 'Time of maximum serum concentration (Tmax) of B001.', 'timeFrame': 'Through study completion, up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of B001.'}, {'measure': 'Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14D) of B001.', 'timeFrame': 'Through study completion, up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of B001.'}, {'measure': 'Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of B001.', 'timeFrame': 'Through study completion, up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of B001.'}, {'measure': 'Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of B001.', 'timeFrame': 'Through study completion, up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of B001.'}, {'measure': 'Accumulation ratio of maximum serum concentration (Rac_Cmax) of B001.', 'timeFrame': 'Through study completion, up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of B001.'}, {'measure': 'Accumulation ratio of area under the serum concentration-time curve (Rac_AUC) of the Dosing Interval (0-14D) of B001.', 'timeFrame': 'Through study completion, up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of B001.'}, {'measure': 'Terminal rate constant(λz) of B001.', 'timeFrame': 'Through study completion, up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of B001.'}, {'measure': 'Half-life (t1/2) of B001.', 'timeFrame': 'Through study completion, up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of B001.'}, {'measure': 'Total clearance(CL) of B001.', 'timeFrame': 'Through study completion, up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of B001.'}, {'measure': 'Volume of distribution(Vz) of B001.', 'timeFrame': 'Through study completion, up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of B001.'}, {'measure': 'Percentage of area under the serum concentration-time curve (AUC 0-infinity) obtained by extrapolation (%AUCex) of B001.', 'timeFrame': 'Through study completion, up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of B001.'}, {'measure': 'Percentage of subjects with ADA to B001 and neutralizing resistance (Nab)', 'timeFrame': 'Through study completion, up to 2 years'}, {'measure': 'Time to First Protocol-Defined Relapse (TFR) in the Double-Blind Period', 'timeFrame': 'Through study completion, up to 2 years'}, {'measure': 'Change in Expanded Disability Status Scale (EDSS) Score', 'timeFrame': 'Through study completion, up to 2 years', 'description': 'The EDSS provides a total score on a scale that ranges from 0 to 10 in 0.5 increments that represent higher levels of disability. Increasing disability is reflected in an increasing EDSS score.'}, {'measure': 'Time to EDSS Worsening', 'timeFrame': 'Through study completion, up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NMO Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'The objectives of this phase Ib study are to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenic profiles of B001 in subjects with aquaporin-4 antibody (AQP4-IgG) positive NMOSD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. NMOSD as defined by either of the following 2015 criteria with anti-AQP4 antibody (Ab) seropositive status at screening\n2. Clinical evidence of at least 1 documented relapse in last 12 months prior to screening\n3. Expanded Disability Status Scale (EDSS) score from 0 to 7.5 inclusive at screening\n4. Age 18 to 70 years, inclusive at the time of informed consent\n\nExclusion Criteria:\n\n1. Any previous treatment with anti-CD20, eculizumab, anti-BLyS monoclonal antibody (e.g., belimumab), any other treatment for prevention of multiple sclerosis (MS) relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) within 6 months prior to baseline.\n2. Received immunosuppression such as azathioprine, mycophenolate mofetil, methotrexate, cyclophosphamide, tacrolimus, mitoxantrone, cyclosporine A, etc, and rug therapy, biological agents such as satralizumab, tocilizumab, eculizumab, etc, 3 months prior to the first administration.\n3. Evidence of serious uncontrolled concomitant diseases that may preclude participant participation, as described; Other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency.\n4. Known active infection within 3 months prior to baseline\n5. Pregnancy or lactation.\n6. History of severe allergic reaction to a biologic agent\n7. Evidence of chronic active hepatitis B or C\n8. Evidence of active tuberculosis\n9. Following laboratory abnormalities at screening\\*:\n\n 1. White blood cells (WBC) \\<4.0 x10\\^3/microliter (μL)\n 2. Absolute neutrophil count (ANC)\n 3. Absolute lymphocyte count \\<0.5 x10\\^3/μL\n 4. Platelet count \\<80 x 10\\^9/ L\n 5. Aspartate aminotransferase (AST) or alanine aminotransferase\n10. History of drug or alcohol abuse within 6 months prior to baseline\n11. Receipt of any live or live attenuated vaccine within 4 weeks prior to baseline\n12. Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg), diabetes, gastrointestinal diseases, etc.; or the investigator believes that there is anything inappropriate reasons for selection.'}, 'identificationModule': {'nctId': 'NCT05145361', 'briefTitle': 'Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Pharmaceuticals Holding Co., Ltd'}, 'officialTitle': 'A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of B001 in Subjects With Aquaporin-4 Antibody (AQP4-IgG) Positive Neuromyelitis Optic Spectrum Disorder (NMOSD)', 'orgStudyIdInfo': {'id': 'B001-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B001 injection', 'description': 'Subjects randomized to this arm will receive B001 twice, at day 1 and day 15, up to the end of the study.', 'interventionNames': ['Drug: B001 injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects randomized to this arm will receive Placebo twice, at day 1 and day 15, up to the end of the study.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'B001 injection', 'type': 'DRUG', 'description': 'B001 injection 50mg/5mL Intravenous solution', 'armGroupLabels': ['B001 injection']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo 5mL Intravenous solution', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yunxing Song', 'role': 'CONTACT', 'email': 'songyx@sphchina.com', 'phone': '+86 17813230827'}, {'name': 'Xinghu Zhang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Tiantan Hospital Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '030001', 'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yunxing Song', 'role': 'CONTACT', 'email': 'songyx@sphchina.com', 'phone': '+86 17813230827'}, {'name': 'Meini Zhang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'First Hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '710038', 'city': 'Xi’an', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shicao Li', 'role': 'CONTACT', 'email': 'tangduec@126.com', 'phone': '0086-029-84717761'}, {'name': 'Jun Guo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tangdu hospital,fourth military medical university', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chao Zhang, MD', 'role': 'CONTACT', 'email': 'chaozhang@tmu.edu.can', 'phone': '022-60814587'}, {'name': 'Fu-Dong Shi, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Fu-Dong Shi, MD,PhD', 'role': 'CONTACT', 'email': 'Shifudong219@163.com', 'phone': '022-60814587'}], 'overallOfficials': [{'name': 'Fu-Dong Shi, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Medical University General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Pharmaceuticals Holding Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}