Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-31 @ 12:27 PM
Study NCT ID:
NCT05070858
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2021-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Test How Safe Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Alone Are and How Well They Work in Adult Patients With Generalized Myasthenia Gravis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Czechia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}], 'ancestors': [{'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, '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': 'ACTUAL', 'count': 288}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-11-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2021-09-27', 'studyFirstSubmitQcDate': '2021-09-27', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score', 'timeFrame': 'From baseline to week 24', 'description': 'The total MG-ADL score ranges from 0 to 24 points, with higher scores indicating greater functional impairment and disability'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Quantitative Myasthenia Gravis (QMG) score', 'timeFrame': 'Week 24', 'description': 'QMG total scores range from 0 to 39, with higher scores representing greater impairment'}, {'measure': 'Achievement of a ≥3-point reduction (improvement) in MG-ADL total score', 'timeFrame': 'From baseline to week 24'}, {'measure': 'Achievement of a ≥5-point reduction (improvement) in QMG total score', 'timeFrame': 'From baseline to week 24'}, {'measure': 'Achievement of a consistent response on the MG-ADL', 'timeFrame': 'From baseline to week 24', 'description': 'A patient with a ≥2-point reduction (improvement) in MG-ADL total score on 2 or more consecutive assessments spanning 4 or more weeks during the DBTP'}, {'measure': 'Achievement of minimal symptom expression (MSE)', 'timeFrame': 'Week 24', 'description': 'Score of 0 to 1 on the MG-ADL'}, {'measure': 'Change from baseline in the Myasthenia Gravis Composite (MGC) total score', 'timeFrame': 'Week 24', 'description': 'MGC score ranges from 0 to 50, with higher score indicating higher impairment'}, {'measure': 'Change from baseline in Myasthenia Gravis Quality of Life (MG QOL15r) total score', 'timeFrame': 'Week 24', 'description': 'Total score ranges from 0 to 30 points; a higher score represents greater impairment'}, {'measure': 'Achievement of a ≥2-, 4-, 5-, 6-, 7-, 8-, 9-, or 10-point reduction on MG-ADL total score', 'timeFrame': 'From baseline to week 24'}, {'measure': 'Achievement of a ≥3-, 4-, 6-, 7-, 8-, 9-, or 10-point reduction on QMG', 'timeFrame': 'From baseline to week 24'}, {'measure': 'Incidence and severity of treatment-related adverse events (TEAEs) in patients treated with pozelimab + cemdisiran, cemdisiran monotherapy or placebo', 'timeFrame': 'Through week 24'}, {'measure': 'Incidence and severity of serious adverse events (SAEs) in patients treated with pozelimab + cemdisiran, cemdisiran monotherapy or placebo', 'timeFrame': 'Through week 24'}, {'measure': 'Incidence and severity of adverse events of special interest (AESIs) in patients treated with pozelimab + cemdisiran, cemdisiran monotherapy or placebo', 'timeFrame': 'Through week 24'}, {'measure': 'Concentrations of total pozelimab in serum', 'timeFrame': 'Through study duration, approximate 172 weeks'}, {'measure': 'Concentrations of total complement component 5 (C5) in plasma', 'timeFrame': 'Through study duration, approximate 172 weeks'}, {'measure': 'Concentrations of cemdisiran and its metabolites in plasma', 'timeFrame': 'Through study duration, approximate 172 weeks'}, {'measure': 'Incidence of treatment-emergent anti-drug antibodies (ADAs) to pozelimab over time', 'timeFrame': 'Through study duration, approximately 172 weeks'}, {'measure': 'Incidence of treatment-emergent ADAs to cemdisiran over time', 'timeFrame': 'Through study duration, approximate 172 weeks'}, {'measure': 'Change in total complement hemolysis activity assay (CH50) over time', 'timeFrame': 'Through study duration, approximately 172 weeks'}, {'measure': 'Percent change in CH50 over time', 'timeFrame': 'Through study duration, approximately 172 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Generalized Myasthenia Gravis']}, 'descriptionModule': {'briefSummary': 'This study is researching the experimental drugs called pozelimab and cemdisiran, and cemdisiran monotherapy. The study is focused on patients with generalized myasthenia gravis (gMG). Myasthenia gravis is a disease that causes weakness and fatigue in muscles in the body because the nerves and muscles are not communicating properly. The aim of the study is to see how effective pozelimab and cemdisiran are when used in combination and when pozelimab and cemdisiran are used alone for patients with gMG.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drugs\n* How the study drugs work inside the body\n* How much study drugs are in the blood at different times\n* Whether the body makes antibodies against pozelimab and cemdisiran (which could make the drugs less effective or could lead to side effects)', 'detailedDescription': 'DBTP- Double blind treatment period (24 weeks) ETP - Extension treatment period (28 weeks) OLTP- Open label treatment period (68 weeks) Off-treatment follow up period (52 weeks)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Male or female patients ≥18 years of age at screening (or ≥ legal age of adulthood based on local regulations, whichever is older)\n2. Patient with documented diagnosis of myasthenia gravis (MG) based on medical history and supported by previous evaluations as described in the protocol\n3. Documented prior history of positive serologic test or a positive result during screening of anti-acetylcholine receptor (AChR) antibodies or anti-LRP4 antibodies.\n4. Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IVa at screening\n5. Myasthenia Gravis-Activities of Daily Living (MG-ADL) score ≥6 at screening. Ocular items should not contribute more than 50% of MG-ADL total score as described in the protocol\n6. Currently receiving an acetylcholinesterase inhibitor or documented reason for not using acetylcholinesterase inhibitor therapy per investigator\n7. Currently receiving an immunosuppressive therapy (IST) for MG, or documented reason why the patient is not taking an IST per investigator\n8. If currently receiving an IST, not anticipated to have IST dosage changed before randomization or during double-blind treatment period (DBTP).\n9. Willing and able to comply with clinic visits and study-related procedures, including completion of the primary series of the meningococcal vaccinations required per protocol\n\nKey Exclusion Criteria:\n\n1. Patients with antibody profile that is only positive for muscle specific tyrosine kinase (MuSK) (MuSK positivity is based on a documented prior history of positive serologic test for antibodies to MuSK or a positive result during screening\n2. History of thymectomy within 12 months prior to screening or planned during the study\n3. History of malignant thymoma (patients with stage 1 may be enrolled), or history of cancer within the past 5 years, except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer\n4. Myasthenic crisis or Myasthenia Gravis Foundation of America (MGFA) Class V within 1 month of screening\n5. Not meeting meningococcal vaccination requirements and, at a minimum, documentation of quadrivalent meningococcal vaccination within 5 years prior to randomization and serotype B vaccine (when available) within 3 years prior to randomization as described in the protocol\n6. Known contraindication to meningococcal vaccines (group ACWY conjugate and group B vaccines) as described in the protocol\n7. Patients who require antibiotics for meningococcal prophylaxis and have a contraindication, warning, or precaution precluding the use of penicillin class and penicillin-alternative antibiotics planned to be used for prophylaxis, or a history of intolerance leading to the discontinuation of these antibiotics\n8. Positive hepatitis B surface antigen or hepatitis C virus ribonucleic acid (RNA) during screening. NOTE: Cases with unclear interpretation should be discussed with the medical monitor\n9. History of HIV infection or a positive test at screening per local requirements\n\nNOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply'}, 'identificationModule': {'nctId': 'NCT05070858', 'acronym': 'NIMBLE', 'briefTitle': 'A Study to Test How Safe Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Alone Are and How Well They Work in Adult Patients With Generalized Myasthenia Gravis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Monotherapy in Patients With Symptomatic Generalized Myasthenia Gravis', 'orgStudyIdInfo': {'id': 'R3918-MG-2018'}, 'secondaryIdInfos': [{'id': '2020-003272-41', 'type': 'EUDRACT_NUMBER'}, {'id': '2023-508842-17-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Placebo in DBTP; Re-randomized to Combination or Cemdisiran in ETP and OLTP', 'interventionNames': ['Drug: Pozelimab + Cemdisiran', 'Drug: Cemdisiran', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Combination regimen throughout the study', 'interventionNames': ['Drug: Pozelimab + Cemdisiran']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'Cemdisiran throughout the study', 'interventionNames': ['Drug: Cemdisiran']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'Pozelimab monotherapy in DBTP followed by combination in ETP and OLTP', 'interventionNames': ['Drug: Pozelimab']}], 'interventions': [{'name': 'Pozelimab + Cemdisiran', 'type': 'DRUG', 'description': 'Subcutaneous administration as described in the protocol', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'Cemdisiran', 'type': 'DRUG', 'otherNames': ['ALN-CC5'], 'description': 'SC administration as described in the protocol', 'armGroupLabels': ['Group 1', 'Group 3']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'SC administration as described in the protocol', 'armGroupLabels': ['Group 1']}, {'name': 'Pozelimab', 'type': 'DRUG', 'otherNames': ['REGN3918'], 'description': 'SC administration as described in the protocol', 'armGroupLabels': ['Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'HonorHealth Neurology 2018', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80907-5307', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Springs Neurological Associates', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '33487', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'SFM Clinical Research, LLC', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Diverse Clinical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34105', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Aqualane Clinical Research', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurological Services of Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33952', 'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'Medsol Clinical Research Center Inc', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida Morsani Center for Advanced Healthcare', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60026-1301', 'city': 'Glenview', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University Health System', 'geoPoint': {'lat': 42.06975, 'lon': -87.78784}}, {'zip': '62269', 'city': "O'Fallon", 'state': 'Illinois', 'country': 'United States', 'facility': "St. Elizabeth's Hospital", 'geoPoint': {'lat': 38.59227, 'lon': -89.91121}}, {'zip': '60080', 'city': 'Rolling Meadows', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwest Neurology Ltd. - 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