Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-01-01 @ 2:02 PM
Study NCT ID:
NCT06453668
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-12
First Post:
2024-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C544394', 'term': 'siplizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2024-05-06', 'studyFirstSubmitQcDate': '2024-06-10', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the safety of TCD601 in adult patients with ALS', 'timeFrame': '12 Months', 'description': 'Assess the incidence of treatment-emergent Adverse Events \\[Safety and Tolerability\\]'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the pharmacokinetics (PK)', 'timeFrame': '12 Months', 'description': 'Siplizumab concentration over time'}, {'measure': 'Correlation of ALS disease status with leucocyte phenotypic profiles', 'timeFrame': '12 Months'}, {'measure': 'Evaluation of levels of biomarkers', 'timeFrame': '12 Months', 'description': 'Neurofilament light chain levels over time'}, {'measure': 'Length of time from trial entry to tracheostomy / death', 'timeFrame': '12 Months'}, {'measure': 'Assessment of clinically relevant changes in laboratory measurements', 'timeFrame': '12 Months', 'description': 'Incidence of abnormal laboratory values'}, {'measure': 'Evaluation of pharmacodynamics (PD) of TCD601', 'timeFrame': '12 Months', 'description': 'Lymphocyte counts by subset over time'}, {'measure': 'Assessment of clinically relevant changes in vital signs', 'timeFrame': '12 Months', 'description': 'Incidence of abnormal vital signs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amyotrophic Lateral Sclerosis', 'Neuroinflammatory'], 'conditions': ['ALS']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TCD601 (siplizumab) in newly diagnosed adult ALS patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Male or female patients ≥ 18 to 80 years of age.\n* Diagnosis of ALS by revised El Escorial Criteria, at study entry within 24 months of first symptoms.\n* Patients on existing ALS treatment must have been on a stable dose for 28 days.\n\nKey Exclusion Criteria:\n\n* Patient with severe systemic infections, current or within the two weeks prior to randomization.\n* Subjects who, in the opinion of the investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirements outlined in the protocol.\n* Use of other investigational products or treatment in another investigational drug study within 30 days of screening\n* Pregnant or nursing (lactating) women.'}, 'identificationModule': {'nctId': 'NCT06453668', 'acronym': 'AURORA', 'briefTitle': 'A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'ITB-Med LLC'}, 'officialTitle': 'A 52-week, Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Trial of Siplizumab in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients (AURORA)', 'orgStudyIdInfo': {'id': 'TCD601H101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'TCD601 (siplizumab) administered with the contemporary standard of care regimen.', 'interventionNames': ['Biological: TCD601']}], 'interventions': [{'name': 'TCD601', 'type': 'BIOLOGICAL', 'otherNames': ['siplizumab'], 'description': 'Investigational Product', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '205 02', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Skåne University Hospital Malmö', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '171 77', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Studieenheten Akademiskt Specialistcentrum', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '901 85', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'Umeå University Hospital', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'overallOfficials': [{'name': 'Fredrik Julin', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ITB-Med LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ITB-Med LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}