Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-27 @ 1:18 AM
Study NCT ID:
NCT04053803
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-03-04
First Post:
2019-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-06-17', 'mcpReleaseN': 3, 'releaseDate': '2022-05-24'}, {'resetDate': '2022-07-19', 'mcpReleaseN': 4, 'releaseDate': '2022-06-29'}, {'resetDate': '2025-05-13', 'mcpReleaseN': 5, 'releaseDate': '2025-04-29'}], 'estimatedResultsFirstSubmitDate': '2022-05-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-02', 'studyFirstSubmitDate': '2019-07-18', 'studyFirstSubmitQcDate': '2019-08-08', 'lastUpdatePostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with adverse events and serious adverse events', 'timeFrame': 'Baseline to Month 49', 'description': '1. Incidence of Adverse Events\n2. Incidence of Serious Adverse Events'}, {'measure': 'Proportion of patients with changes in safety cardiac parameters', 'timeFrame': 'Baseline to Month 49', 'description': 'a. Changes in 12-lead ECG parameters that are clinically significant and measured in milliseconds (ms).\n\nThe parameters are: PR interval, QRS duration, QT interval, ST segment duration and T wave duration.'}, {'measure': 'Proportion of patients with changes in clinical laboratory tests', 'timeFrame': 'Baseline to Month 49', 'description': 'a. Clinically significant changes in clinical laboratory tests including serum chemistry, serum hematology and urinalysis'}, {'measure': 'Proportion of patients with clinically significant abnormal vital signs', 'timeFrame': 'Baseline to Month 49', 'description': '1. Blood pressure measured in mmHg\n2. Pulse measured in beats per minute\n3. Respiration rate measured in breaths per minutes\n4. Temperature as measured in degrees F0 or C0'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sickle Cell Disease']}, 'descriptionModule': {'briefSummary': "This is an open-label extension study of IMR-687 in adult patients who completed Imara's blinded Phase 2a study (IMR-SCD-102). The open-label extension study will evaluate long-term safety and tolerability.", 'detailedDescription': 'This is an open-label extension study of IMR-687 in adult patients with SCA who were previously participants in the Phase 2a study titled "A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study of IMR-687 in Adult Patients with Sickle Cell Anaemia (Homozygous HbSS or Sickle-β0 Thalassemia)."\n\nThis open-label extension study with IMR-687 will evaluate the long-term safety and tolerability of IMR 687 in adult SCA patients. Exploratory long-term PD parameters will also be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Completed Study IMR-SCD-102.\n2. Female subjects must not be pregnant, not be breast feeding, and be highly unlikely to become pregnant. Male subjects must be unlikely to impregnate a partner.\n3. Subjects must be capable of giving informed consent and reading and signing the informed consent form after the nature of the study has been fully explained to them\n4. Subjects must be willing and able to complete all study assessments and procedures and to communicate effectively with the investigator and site staff.\n\nExclusion Criteria:\n\n1. Subjects with Hb \\>12.5 g/dL or \\<6 g/dL\n2. Subjects with known active hepatitis B or hepatitis C, with active or acute event of malaria or who are known to be positive for human immunodeficiency virus (HIV)\n3. eGFR \\<50 mL/min\n4. AST/ALT \\> 3x the upper limit of normal'}, 'identificationModule': {'nctId': 'NCT04053803', 'briefTitle': 'An Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Imara, Inc.'}, 'officialTitle': 'An Open-label Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia (Homozygous HbSS or Sickle-β0 Thalassemia) Who Participated in Study IMR-SCD-102', 'orgStudyIdInfo': {'id': 'IMR-SCD-102-EXT'}, 'secondaryIdInfos': [{'id': '2018-003805-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open Label', 'interventionNames': ['Drug: IMR-687']}], 'interventions': [{'name': 'IMR-687', 'type': 'DRUG', 'description': 'Oral administration of once daily IMR-687', 'armGroupLabels': ['Open Label']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Connecticut Health Center', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Foundation for Sickle Cell Disease Research', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott & White Medical Center - Temple', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Bristol Haematology and Oncology Centre', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'NW1 2PG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's and St Thomas Hospital CRF", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Karen Tang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Imara, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imara, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}