Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-24 @ 5:07 PM
Study NCT ID:
NCT04119050
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2019-09-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'Mexico']}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 111}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT05221619', 'statusForNctId': 'TEMPORARILY_NOT_AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-04-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2019-09-18', 'studyFirstSubmitQcDate': '2019-10-04', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Durable Response of Improvement in Hemoglobin (Hgb)', 'timeFrame': 'Up to Week 20 of the double-blind period'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the Total Score From the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale at the Time of Durable Response', 'timeFrame': 'Baseline (Day 1, Week 0) through Week 24', 'description': 'The FACIT-Fatigue is a self-administered 13-item questionnaire that assess patient-reported fatigue associated with chronic illness therapy. It assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement.'}, {'measure': 'Change From Baseline in the Total Score From the FACIT-Fatigue Scale at the end of the Double-blind Period (Week 24)', 'timeFrame': 'Baseline (Day 1, Week 0) through Week 24 of the double-blind period', 'description': 'The FACIT-Fatigue is a self-administered 13-item questionnaire that assess patient-reported fatigue associated with chronic illness therapy. It assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement.'}, {'measure': 'Change from Baseline in Average Daily Dose of Prednisone or Equivalent', 'timeFrame': 'Baseline (Day 1, Week 0) and at Week 24', 'description': 'Change from baseline in average daily dose of prednisone or equivalent at week 24 among participants on prednisone or equivalent at baseline will be reported.'}, {'measure': 'Number of Participants That Simultaneously Attain Normal Lactate Dehydrogenase, Haptoglobin, and Indirect Bilirubin Levels at a Minimum of 3 Consecutive Visits After Baseline', 'timeFrame': 'Baseline (Day 1, Week 0) through Week 24'}, {'measure': 'Percentage of Participants who Experience at Least a 2 g/dL Increase in Hgb From Baseline and Normalization of Lactate Dehydrogenase, Haptoglobin, and Indirect Bilirubin at any Time During the Study', 'timeFrame': 'Baseline (Day 1, Week 0) through Week 24'}, {'measure': 'Percentage of Participants who Experience at Least a 2 g/dL Increase in Hgb From Baseline and Normalization of Lactate Dehydrogenase, Haptoglobin, and Indirect Bilirubin at 3 Consecutive Visits', 'timeFrame': 'Baseline (Day 1, Week 0) through Week 24'}, {'measure': 'Percentage of Participants who Achieve the Durable Response in Improvement of Hgb During the Double-blind Period and Maintain that Response for Up to 24 Weeks, Without the Need of Rescue Therapy', 'timeFrame': 'Up to 24 weeks', 'description': 'Percentage of participants who achieve the durable response in improvement of Hgb during the double-blind period and maintain that response for up to 24 weeks, without the need of rescue therapy will be reported.'}, {'measure': 'Change From Baseline in Hgb Concentration', 'timeFrame': 'Baseline (Day 1, Week 0) through Week 24'}, {'measure': 'Change From Baseline in Reticulocyte Count', 'timeFrame': 'Baseline (Day 1, Week 0) through Week 24'}, {'measure': 'Change From Baseline in Hemolytic Marker - Lactate Dehydrogenase', 'timeFrame': 'Baseline (Day 1, Week 0) through Week 24'}, {'measure': 'Change From Baseline in Hemolytic Marker - Haptoglobin', 'timeFrame': 'Baseline (Day 1, Week 0) through Week 24'}, {'measure': 'Change From Baseline in Hemolytic Marker - Indirect Bilirubin', 'timeFrame': 'Baseline (Day 1, Week 0) through Week 24'}, {'measure': 'Time to Hgb Response', 'timeFrame': 'Baseline (Day 1, Week 0) through Week 24'}, {'measure': 'Mean Time During Which the Primary Endpoint is Maintained', 'timeFrame': 'Baseline (Day 1, Week 0) through Week 24'}, {'measure': 'Change From Baseline in the Total Score, Item Scores, and Impact and Experience Domains From the FACIT-Fatigue Scale', 'timeFrame': 'Baseline (Day 1, Week 0) through Week 24 of the double-blind period', 'description': 'The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement.'}, {'measure': 'Change From Baseline in EuroQol 5-dimension 5-level ( EQ-5D-5L) Scale Score', 'timeFrame': 'Baseline (Day 1, Week 0) through Week 24', 'description': 'The EQ-5D-5L quality of life questionnaire will be used to assess health related quality of life status. The 5 dimensions are mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension is rated by the patient on a 5 level scale (no problems, slight problems, moderate problems, severe problems, extreme problems).'}, {'measure': 'Change From Baseline in Medical Outcomes Study Short Form 36 Item Health Survey Version 2 Acute (SF-36v2) Score', 'timeFrame': 'Baseline (Day 1, Week 0) through Week 24', 'description': 'The SF-36v2 will be used to assess general quality of life. The 36 items on the SF-36 health survey encompass the following 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 8 domains can be aggregated into 2 summary scales that reflect physical and mental health: a physical component summary (PCS) and a mental component summary (MCS). Responses to all items are rated on a 3-, 5- or 6-point Likert scale. Higher scores indicate a higher level of functioning. A positive change from baseline score indicates an improvement.'}, {'measure': 'Change From Baseline in Patient Global Impression of Severity (PGIS)', 'timeFrame': 'Baseline (Day 1, Week 0) through Week 24', 'description': 'The PGIS will be used to assess the severity of warm autoimmune hemolytic anemia (wAIHA) fatigue symptoms. The PGIS is a 5-point response scale. Participant will be asked to rate their fatigue over the past 7 days using the following 5-point scale: 1 = None, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very severe.'}, {'measure': 'Patient-reported Status As Assessed by Patient Global Impression of Change (PGIC) Scale Score', 'timeFrame': 'At Week 24', 'description': 'The PGIC will assess if there has been an improvement or decline in patient-reported status since the beginning of the treatment. The PGIC is a 7-point response scale. Participants will be asked to rate their current fatigue as compared to when they started the study, using the following 7-point scale: 1 = Much better, 2 = Moderately better, 3 = A little better, 4 = No change, 5 = A little worse, 6 = Moderately worse, and 7 = Much worse.'}, {'measure': 'Hgb Range at Steady State', 'timeFrame': 'Baseline (Day 1, Week 0) through Week 24', 'description': 'It will be estimated using a model-based longitudinal analysis of Hgb/hemolysis parameters in relationship to IgG level and dose regimen.'}, {'measure': 'Absolute Change from Baseline in Average Daily Dose of Prednisone or Equivalent', 'timeFrame': 'Baseline (Day 1, Week 0) and at Week 24', 'description': 'Absolute change from baseline in average daily dose of prednisone or equivalent at Week 24 among all participants will be reported.'}, {'measure': 'Percentage of participants who Achieve Corticosteroid Reduction to less than or equal to (<=) 7.5 milligrams per day (mg/day) of Oral Prednisone (or Equivalent), Among Participants with Prednisone or Equivalent greater than (>) 7.5 mg/day at Baseline', 'timeFrame': 'At Week 24', 'description': 'Percentage of participants who achieve corticosteroid reduction to \\<= 7.5 mg/day of oral prednisone (or equivalent) at Week 24 of the double-blind period, among participants with prednisone or equivalent \\>7.5 mg/day at baseline will be reported.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Warm Autoimmune Hemolytic Anemia', 'M281 (Nipocalimab)', 'wAIHA', 'JNJ-80202135'], 'conditions': ['Warm Autoimmune Hemolytic Anemia']}, 'referencesModule': {'references': [{'pmid': '33786812', 'type': 'DERIVED', 'citation': 'Liu AP, Cheuk DK. Disease-modifying treatments for primary autoimmune haemolytic anaemia. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012493. doi: 10.1002/14651858.CD012493.pub2.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&parentIdentifier=CR108987&attachmentIdentifier=8895a4ed-7f9f-4d12-b738-91162ef80bd5&fileName=Energy_Study_Patient_Poster__(1).pdf&versionIdentifier=', 'label': 'Participant recruitment poster'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).', 'detailedDescription': 'The study consists of a 24-week double-blind, placebo control period, a 144-week open-label extension period and follow-up period of 8 weeks after last study drug administration. Eligible participants will be randomized to placebo or nipocalimab (2 dose levels) during the double-blind period and nipocalimab (2 dose levels) during the open-label extension period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Participants greater than or equal to (\\>=)18 years of age\n* Have been diagnosed with warm autoimmune hemolytic anemia (wAIHA) for at least 3 months, and are currently receiving treatment for wAIHA or have previously received treatment for wAIHA (treatment-naive participants are not eligible)\n* Participants must be able to understand and voluntarily provide written informed consent to participate in the study and comply with all study procedures\n\nExclusion criteria:\n\n* Participants must not be pregnant or breastfeeding\n* Participants must not have other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate\n* Have been diagnosed with cold antibody autoimmune hemolytic anemia (AIHA), cold agglutinin syndrome, mixed type (that is, warm and cold) AIHA, or paroxysmal cold hemoglobinuria'}, 'identificationModule': {'nctId': 'NCT04119050', 'acronym': 'ENERGY', 'briefTitle': 'Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study With a Long-term Open-label Extension', 'orgStudyIdInfo': {'id': 'CR108987'}, 'secondaryIdInfos': [{'id': 'MOM-M281-006', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2019-000720-17', 'type': 'EUDRACT_NUMBER'}, {'id': '2023-505321-14-00', 'type': 'REGISTRY', 'domain': 'EUCT number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'M281 administered every 4 weeks (double-blind period)', 'description': 'Participants will receive M281 administered every 4 weeks alternating with placebo every 4 weeks during the 24 weeks double-blind period.', 'interventionNames': ['Drug: M281', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'M281 administered every 2 weeks (double-blind period)', 'description': 'Participants will receive M281 administered every 2 weeks during the 24 weeks double-blind period.', 'interventionNames': ['Drug: M281']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo administered every 2 weeks (double-blind period)', 'description': 'Participants will receive M281 matching placebo administered every 2 weeks during the 24 weeks double-blind period.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'M281 administered every 4 weeks (open-label extension period)', 'description': 'Participants will receive M281 administered every 4 weeks during the 144 weeks open-label extension period.', 'interventionNames': ['Drug: M281']}, {'type': 'EXPERIMENTAL', 'label': 'M281 administered every 2 weeks (open-label extension period)', 'description': 'Participants will receive M281 administered every 2 weeks during the 144 weeks open-label extension period.', 'interventionNames': ['Drug: M281']}], 'interventions': [{'name': 'M281', 'type': 'DRUG', 'otherNames': ['Nipocalimab, JNJ-80202135'], 'description': 'M281 injection administered as intravenous infusion', 'armGroupLabels': ['M281 administered every 2 weeks (double-blind period)', 'M281 administered every 2 weeks (open-label extension period)', 'M281 administered every 4 weeks (double-blind period)', 'M281 administered every 4 weeks (open-label extension period)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo administered as intravenous infusion', 'armGroupLabels': ['M281 administered every 4 weeks (double-blind period)', 'Placebo administered every 2 weeks (double-blind period)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'MemorialCare Medical Group', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92501', 'city': 'Riverside', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Compassionate Cancer Care', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'American Institute of Research', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33024', 'city': 'Cooper City', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'GNP Research', 'geoPoint': {'lat': 26.05731, 'lon': -80.27172}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'University of Florida College of Medicine', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': '21st Century Oncology', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Lakes Research', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '32804', 'city': 'Orlando', 'state': 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'country': 'United States', 'facility': 'University of Wisconsin Carbone Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '18610-070', 'city': 'Botucatu', 'status': 'COMPLETED', 'country': 'Brazil', 'facility': 'Hospital das Clínicas da Faculdade de Medicina de Botucatu', 'geoPoint': {'lat': -22.88583, 'lon': -48.445}}, {'zip': '71681-603', 'city': 'Brasília', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'Impar Servicos Hospitalares S/A - Hospital Brasilia', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}, {'zip': '13083-887', 'city': 'Campinas', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'CTO Centro de Tratamento Oncologico Unidade Belem', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '74605-020', 'city': 'Goiânia', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'Hospital Das Clinicas Da Universidade Federal De Goias', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '24020-096', 'city': 'Niterói', 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