Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-01-05 @ 6:05 PM
Study NCT ID:
NCT07129759
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-19
First Post:
2025-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004393', 'term': 'Dwarfism, Pituitary'}], 'ancestors': [{'id': 'D004392', 'term': 'Dwarfism'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D007018', 'term': 'Hypopituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2030-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-15', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the long-term safety and tolerability of LUM-201', 'timeFrame': 'Day 1 - Month 36', 'description': '* The number of subjects with at least 1 (serious) treatment-related adverse event (TEAE).\n* The number of subjects with at least 1 suspected unexpected serious adverse reaction.\n* The number of subjects with clinically significant abnormalities related to trial laboratory tests or electrocardiograms (ECGs).\n* The number of subjects with at least 1 adverse event of special interest (AESI).\n* Annual change from baseline in body weight standard deviation score (SDS).\n* Annual change from baseline in body mass index (BMI) SDS.'}], 'secondaryOutcomes': [{'measure': 'To evaluate the long-term effect of LUM-201 on growth.', 'timeFrame': 'Day 1 - Month 36', 'description': '* Annual height velocity.\n* Annual change in height standard deviation score (SDS).\n* Annual change in body mass index (BMI).\n* Annual change in BMI SDS.\n* Annual change in bone age (BA)/chronological age (CA) ratio.'}, {'measure': 'To evaluate the long-term effect of LUM-201 on pharmacodynamic (PD) markers.', 'timeFrame': 'Day 1 - Month 36', 'description': '* Annual change in insulin-like growth factor (IGF)-1 SDS.\n* Annual change in insulin-like growth binding protein 3 (IGFBP-3) SDS.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Growth Hormone Deficiency (GHD)']}, 'descriptionModule': {'briefSummary': 'This is a Multi-national Trial. The Goal of the Trial is to Offer Subjects Who Complete 12 Months in the LUM-201-10 Phase 3 Trial up to an Additional 36 Months of Treatment of LUM-201 While Evaluating Safety and Tolerability of LUM-201.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parent/caregiver must be willing to provide written informed consent, and the subject must sign the assent, as applicable.\n* Subject must have successfully completed 12 months of participation in the LUM-201 Phase 3 GHD trial, and be eligible for continuation of treatment, pending all other enrollment criteria are met.\n* Subject who is sexually active must use an acceptable form of contraception.\n* Subject must be eligible for the Day 1 visit as confirmed by the Investigator.\n\nExclusion Criteria:\n\n* Subject has a medical or genetic condition that, in the opinion of the Investigator and/or MMs, adds unwarranted risk to use of LUM-201.\n* Pregnancy.\n* Subject has planned or is receiving current long-term treatment with medications known to prolong the QT interval or act as substrates, inducers, or inhibitors of the cytochrome system cytochrome P450 type 3A4 that metabolizes LUM-201 (see Appendix 6 for list of example medications). Subjects receiving shorter-term (two weeks or less) treatment with these medications should be evaluated on case-by-case basis by the Investigator in consultation with the MMs.'}, 'identificationModule': {'nctId': 'NCT07129759', 'briefTitle': 'Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lumos Pharma'}, 'officialTitle': 'A Long-term Extension Study to Evaluate the Safety and Tolerability of Daily Oral LUM-201 in Children With Growth Hormone Deficiency (GHD)', 'orgStudyIdInfo': {'id': 'LUM-201-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LUM-201', 'interventionNames': ['Drug: LUM-201']}], 'interventions': [{'name': 'LUM-201', 'type': 'DRUG', 'description': '1.6 mg/kg/day, administered orally once daily', 'armGroupLabels': ['LUM-201']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lumos Pharma', 'role': 'CONTACT', 'email': 'clinical.trials@lumos-pharma.com', 'phone': '515-598-2921'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lumos Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}