Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-01-29 @ 2:06 PM
Study NCT ID:
NCT04280718
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-29
First Post:
2020-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020277', 'term': 'Polyradiculoneuropathy, Chronic Inflammatory Demyelinating'}], 'ancestors': [{'id': 'D011129', 'term': 'Polyradiculoneuropathy'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718373', 'term': 'efgartigimod alfa'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 229}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2020-02-20', 'studyFirstSubmitQcDate': '2020-02-20', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events and serious adverse events', 'timeFrame': 'Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study'}], 'secondaryOutcomes': [{'measure': 'Change from baseline over time of the adjusted INCAT score', 'timeFrame': 'Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study', 'description': 'The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).'}, {'measure': 'Change from baseline over time of the MRC Sum score', 'timeFrame': 'Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study', 'description': 'The Medical Research Council Sum Score evaluates motor strength. Evaluated on 6 muscle groups on each side, the score varies from 0 to 60 (lower score, worse outcome).'}, {'measure': 'Change from baseline over time of I-RODS disability scores', 'timeFrame': 'Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study', 'description': 'Inflammatory Rasch-built Overall Disability Scale (I-RODS) assesses the limitations of activities and social participation in patients with inflammatory neuropathies like CIDP. The score ranges from 0 to 100 (higher score, worse outcome).'}, {'measure': 'Change from baseline over time of mean grip strength', 'timeFrame': 'Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study'}, {'measure': 'Change from baseline over time of TUG score', 'timeFrame': 'Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study', 'description': "The Timed Up and Go Test (TUG) is a simple test to assess a person's mobility in which the time expended to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down is measured."}, {'measure': 'Percentage of patients without clinical deterioration over time, defined by adjusted INCAT deterioration ≥1 point compared to baseline.', 'timeFrame': 'Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study', 'description': 'The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).'}, {'measure': 'Percentage of patients with titers of binding antibodies towards efgartigimod and the presence of neutralizing antibodies against efgartigimod.', 'timeFrame': 'Up to 51 weeks'}, {'measure': 'Efgartigimod serum concentrations', 'timeFrame': 'Up to 51 weeks'}, {'measure': 'Changes from baseline over time of serum IgG levels (total)', 'timeFrame': 'Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study'}, {'measure': 'Change from baseline over time in EQ-5D-5L', 'timeFrame': 'Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study', 'description': 'EQ-5D-5L questionnaire is a patient-reported outcome measure, ranging 0 to 100 (lower score, worse outcome).'}, {'measure': 'Change from baseline over time in BPI SF', 'timeFrame': 'Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study', 'description': 'The Brief Pain Inventory-Short Form (BPI-SF) is a patient-reported outcome measure to assess pain severity and pain interference'}, {'measure': 'Change from baseline over time in TSQM-9', 'timeFrame': 'Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study', 'description': 'The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 9-item questionnaire to assess treatment satisfaction in naturalistic study designs, in which there is potential that the administration of the side effects domain of the TSQM would interfere with routine clinical care'}, {'measure': 'Change from baseline over time in RT-FSS', 'timeFrame': 'Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study', 'description': 'The Rasch-Transformed Fatigue Severity Scale (RT-FSS) is a 7-item self-reported questionnaire designed to differentiate fatigue from clinical depression. The participant has to rate from 0 to 3 their level of fatigue on 7 items (low score indicates that the statement is not very appropriate, and high score indicates agreement).'}, {'measure': 'Change from baseline over time in HADS', 'timeFrame': 'Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study', 'description': 'The Hospital Anxiety and Depression Scale (HADS) aims to measure symptoms of anxiety and depression in people with physical health problems. HADS is a 14-item scale with 7 items related to anxiety and 7 to depression'}, {'measure': 'Percentage of patients performing self-administration over time', 'timeFrame': 'Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study'}, {'measure': 'Percentage of patients with treatment administered by caregiver over time.', 'timeFrame': 'Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)']}, 'descriptionModule': {'briefSummary': 'This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.\n\nPatients already stabilized on efgartigimod PH20 SC will also have the opportunity to participate in a sub study to explore less frequent dosing of efgartigimod PH20 SC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability to understand the requirements of the trial, provide written informed consent (including consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits) of this trial.\n2. Male or female patient with one of the following options:\n\n * Have completed the Week-48 visit of Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC; or\n * Have deteriorated during Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC, or\n * Have been offered the participation in the OLE trial due to early termination of the ARGX-113-1802 trial (because sufficient events for the primary endpoint analysis of the that trial have been reached and it is stopped) and are considered to be eligible for treatment with efgartigimod PH20 SC treatment; or\n * Have completed the Week-48 visit of the previous cycle of the OLE trial and are considered to be eligible to continue with efgartigimod PH20 SC treatment.\n3. Women of childbearing potential who have a negative urine pregnancy test at baseline before IMP administration.\n4. Women of childbearing potential must use an acceptable method of contraception from signing the ICF until the date of the last administration of IMP.\n\nExclusion Criteria:\n\n1. Week-48/ED visit in the ARGX-113-1802 trial or the Week-48 visit of the previous OLE participation occurred more than 14 days prior to SD1 of the OLE trial or the start of a new treatment cycle in the OLE trial and more than 21 days since the last dose of IMP.\n2. Pregnant and lactating women and those intending to become pregnant during the trial.\n3. Patients with clinical evidence of other significant serious disease or patients who underwent a recent or have a planned major surgery, or patients who (intend to) use prohibited medications (see protocol) and therapies during the trial, or any other reason which could confound the results of the trial or put the patient at undue risk.'}, 'identificationModule': {'nctId': 'NCT04280718', 'acronym': 'ADHERE+', 'briefTitle': 'A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)', 'organization': {'class': 'INDUSTRY', 'fullName': 'argenx'}, 'officialTitle': 'Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)', 'orgStudyIdInfo': {'id': 'ARGX-113-1902'}, 'secondaryIdInfos': [{'id': '2019-003107-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'efgartigimod PH20 SC', 'description': 'Patients treated with efgartigimod PH20 SC', 'interventionNames': ['Biological: Efgartigimod PH20 SC']}], 'interventions': [{'name': 'Efgartigimod PH20 SC', 'type': 'BIOLOGICAL', 'otherNames': ['ARGX-113'], 'description': 'Subcutaneous administration of efgartigimod', 'armGroupLabels': ['efgartigimod PH20 SC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233-2110', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigator site 0010065', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigator site 0010013', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85028', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigator site 0010055', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92011', 'city': 'Carlsbad', 'state': 'California', 'country': 'United States', 'facility': 'Investigator site 0010032', 'geoPoint': {'lat': 33.15809, 'lon': -117.35059}}, {'zip': '91767-2009', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Investigator site 10190', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '92270-4150', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Investigator site 0010160', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Investigator site 0010071', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigator site 0010057', 'geoPoint': {'lat': 39.57916, 'lon': 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'state': 'Ohio', 'country': 'United States', 'facility': 'Investigator site 0010064', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigator site 0010007', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19126', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigator site 0010047', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator Site 0010066', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator site 0010009', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Investigator site 0010061', 'geoPoint': 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30.66667, 'lon': 104.06667}}, {'zip': '024000', 'city': 'Chifeng', 'country': 'China', 'facility': 'Investigator site 860049', 'geoPoint': {'lat': 42.26833, 'lon': 118.96361}}, {'city': 'Fuzhou', 'country': 'China', 'facility': 'Investigator site 0860038', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510120', 'city': 'Guangzhou', 'country': 'China', 'facility': 'Investigator site 0860050', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guanzhou', 'country': 'China', 'facility': 'Investigator site 0860032', 'geoPoint': {'lat': 28.41559, 'lon': 109.01843}}, {'city': 'Guiyang', 'country': 'China', 'facility': 'Investigator site 0860045', 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'zip': '310003', 'city': 'Hangzhou', 'country': 'China', 'facility': 'Investigator site 0860035', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '250012', 'city': 'Jinan', 'country': 'China', 'facility': 'Investigator site 0860031', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '33008', 'city': 'Nanchang', 'country': 'China', 'facility': 'Investigator site 0860040', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Nanjing', 'country': 'China', 'facility': 'Investigator site 0860043', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Investigator site 0860028', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Investigator site 860047', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'Investigator site 0860042', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '430040', 'city': 'Wuhan', 'country': 'China', 'facility': 'Investigator site 0860034', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430060', 'city': 'Wuhan', 'country': 'China', 'facility': 'Investigator site 0860029', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '710038', 'city': "Xi'an", 'country': 'China', 'facility': 'Investigator site 0860048', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '712000', 'city': 'Xianyang', 'country': 'China', 'facility': 'Investigator site 0860054', 'geoPoint': {'lat': 34.33778, 'lon': 108.70261}}, {'zip': '500-03', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Investigator site 4200010', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Investigator site 0450002', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Investigator site 0450001', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Investigator site 0450003', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Angers', 'country': 'France', 'facility': 'Investigator site 00330034', 'geoPoint': {'lat': 47.47156, 'lon': 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{'lat': 48.85341, 'lon': 2.3488}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Investigator site 0330020', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '4600', 'city': 'Kutaisi', 'country': 'Georgia', 'facility': 'Investigator site 9950020', 'geoPoint': {'lat': 42.26791, 'lon': 42.69459}}, {'zip': '0112', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Investigator site 9950004', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0112', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Investigator site 9950005', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Investigator site 9950002', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Investigator Site 9950003', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Investigator site 490044', 'geoPoint': 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