Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-01 @ 12:36 PM
Study NCT ID:
NCT06577935
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2024-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS (ARTEMIS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Bulgaria', 'Denmark', 'Estonia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-21', 'studyFirstSubmitDate': '2024-08-14', 'studyFirstSubmitQcDate': '2024-08-27', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment of TEAEs (collection and documentation of all adverse events occurring during the study)', 'timeFrame': 'Baseline to 24 months'}, {'measure': 'Number of participants who develop anti-AGA2118 antibodies', 'timeFrame': 'Baseline to 24 months', 'description': 'To assess the formation of anti-AGA2118 antibodies'}, {'measure': 'Evaluation of AGA2118 observed serum concentration levels for the AGA2118 treatment groups at Week 1 post-treatment and trough levels prior to dosing', 'timeFrame': 'Baseline to 24 months', 'description': 'To characterize the pharmacokinetic parameters of the different AGA2118 doses'}], 'primaryOutcomes': [{'measure': 'Percent change from Baseline to Month 12 in lumbar spine bone mineral density', 'timeFrame': '12 months', 'description': 'To determine the effect of treatment with AGA2118 versus placebo at Month 12 on the percent change from Baseline in bone mineral density at the lumbar spine in postmenopausal women with low bone mineral density'}], 'secondaryOutcomes': [{'measure': 'Percent change from Baseline to Months 3 and 6 in lumbar spine, total hip, femoral neck, and one-third distal radius bone mineral density', 'timeFrame': '3 and 6 months', 'description': 'To evaluate the effect of treatment with AGA2118 versus placebo at different timepoints on percent change from Baseline in bone mineral density at the lumbar spine, total hip, femoral neck, and one-third distal radius'}, {'measure': 'Percent change from Baseline to Month 12 in total hip, femoral neck, and one-third distal radius bone mineral density', 'timeFrame': '12 months', 'description': 'To evaluate the effect of treatment with AGA2118 versus placebo at different timepoints on percent change from Baseline in bone mineral density at the lumbar spine, total hip, femoral neck, and one-third distal radius'}, {'measure': 'Percent change from Baseline to Months 1, 3, 6, 9, and 12 in P1NP and CTX-1', 'timeFrame': '1, 3, 6, 9, and 12 months', 'description': 'To evaluate the effect of treatment with AGA2118 versus placebo at different time points on percent change from Baseline in P1NP and CTX-1'}, {'measure': 'Incidence of new clinical fractures (vertebral and nonvertebral) between Baseline and Month 12', 'timeFrame': '12 months', 'description': 'To evaluate the incidence of new clinical fractures (vertebral and nonvertebral) from Baseline to Month 12'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteoporosis'], 'conditions': ['Postmenopausal Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the effect of treatment with AGA2118 versus placebo at Month 12 on lumbar spine bone mineral density (BMD) in postmenopausal women with low bone mass.', 'detailedDescription': 'This Phase 2 dose-finding study will evaluate the safety, tolerability, and efficacy of AGA2118 at a range of dosing regimens in postmenopausal women with low BMD at the lumbar spine, total hip, or femoral neck and no prior history of fragility fractures.\n\nThis study includes a 12 month blinded treatment phase where participants will be randomized 1:1:1:1:1:1:1 to receive double-blind dosing regimens of AGA2118 or placebo. At Month 12, participants who have completed the double-blind portion of the study will continue on to a 12 month open-label period where they will be re-randomized based on their prior dosing regimen to either continue their current dosing regimen, receive a new dosing regimen, or discontinue treatment and be actively surveilled throughout Months 12 to 24.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, ambulatory, postmenopausal women age ≥ 55 to ≤ 80.\n* BMD T-score of ≤ -2.5 to \\> -3.5 at the lumbar spine, total hip, or femoral neck.\n\nExclusion Criteria:\n\n* History of vertebral fracture, or fragility fracture of the wrist, humerus, proximal femur, or pelvis.\n* Vitamin D deficiency.\n* Known intolerance to calcium or vitamin D supplements.\n* Untreated hyper- or hypothyroidism.\n* Current hyper- or hypoparathyroidism.\n* Elevated transaminases.\n* Significantly impaired renal function.\n* Current hypo- or hypercalcemia.\n* Positive for HIV, hepatitis C virus, or hepatitis B surface antigen.\n* Malignancy within the last 5 years.\n* Diagnosis of a familial cancer syndrome or known genetic mutation that increases risk of cancer.\n* Myocardial infarction or stroke within the past 12 months.\n* Use of agents affecting bone metabolism.'}, 'identificationModule': {'nctId': 'NCT06577935', 'acronym': 'ARTEMIS', 'briefTitle': 'A Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS (ARTEMIS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Angitia Biopharmaceuticals'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Safety, Tolerability and Efficacy of AGA2118 in Postmenopausal Women With Low Bone Mineral Density', 'orgStudyIdInfo': {'id': 'ACT23-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AGA2118 Dose Regimen 1', 'description': 'AGA2118 selected dose\n\nParticipants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.', 'interventionNames': ['Drug: AGA2118']}, {'type': 'EXPERIMENTAL', 'label': 'AGA2118 Dose Regimen 2', 'description': 'AGA2118 selected dose\n\nParticipants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.', 'interventionNames': ['Drug: AGA2118']}, {'type': 'EXPERIMENTAL', 'label': 'AGA2118 Dose Regimen 3', 'description': 'AGA2118 selected dose\n\nParticipants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.', 'interventionNames': ['Drug: AGA2118']}, {'type': 'EXPERIMENTAL', 'label': 'AGA2118 Dose Regimen 4', 'description': 'AGA2118 selected dose\n\nParticipants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.', 'interventionNames': ['Drug: AGA2118']}, {'type': 'EXPERIMENTAL', 'label': 'AGA2118 Dose Regimen 5', 'description': 'AGA2118 selected dose\n\nParticipants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.', 'interventionNames': ['Drug: AGA2118']}, {'type': 'EXPERIMENTAL', 'label': 'AGA2118 Dose Regimen 6', 'description': 'AGA2118 selected dose\n\nParticipants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.', 'interventionNames': ['Drug: AGA2118']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Regimen', 'description': 'Placebo selected dose\n\nParticipants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'AGA2118', 'type': 'DRUG', 'description': 'Subcutaneous injection', 'armGroupLabels': ['AGA2118 Dose Regimen 1', 'AGA2118 Dose Regimen 2', 'AGA2118 Dose Regimen 3', 'AGA2118 Dose Regimen 4', 'AGA2118 Dose Regimen 5', 'AGA2118 Dose Regimen 6']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Subcutaneous injection', 'armGroupLabels': ['Placebo Regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kenneth Saag, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Del Sol Research Management, LLC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Angela Ritter, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Center for Advanced Research & Education', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '21502', 'city': 'Cumberland', 'state': 'Maryland', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Klein & Associates, M.D., P.A.', 'geoPoint': {'lat': 39.65287, 'lon': -78.76252}}, {'zip': '59808', 'city': 'Missoula', 'state': 'Montana', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Montana Medical Research, Inc', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '87160', 'city': 'Albuquerque', 'state': 'New Mexico', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'E. Michael Lewiecki, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NM Clinical Research & Osteoporosis Center, Inc.', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alan Kivitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Altoona Center for Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '98166', 'city': 'Burien', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Susan Nattrass, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Puget Sound Osteoporosis Center', 'geoPoint': {'lat': 47.47038, 'lon': -122.34679}}, {'city': 'Buenos Aires', 'state': 'Argentina', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Frederico Ariel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro Médico Arsema', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'state': 'Argentina', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Claudia Scalise, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro Médico Dra Laura Maffei e Investigación Cliínica Aplicada', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'state': 'Argentina', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Pablo Costanzo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Consultorio de Investigacion Clinica EMO SRL', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'state': 'Argentina', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Belen Zanchetta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IDIM', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'state': 'Argentina', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Osvaldo Messina, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Investigaciones Reumatologicas y Osteologicas SRL', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'state': 'Argentina', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Gisela Gianetti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mautalen - Salud e Investigacion (Expertia S.A.)', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'state': 'Argentina', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Lucas Gutnisky, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stat Research', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Córdoba', 'state': 'Argentina', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Liliana Morales, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instituto Médico Strusberg', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'city': 'San Miguel de Tucumán', 'state': 'Argentina', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Walter Spindler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Investigaciones Médicas Tucumán', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'city': 'San Miguel de Tucumán', 'state': 'Tucumán Province', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Argentina', 'facility': 'Centro de Investigaciones Médicas Tucumán', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Maria Julia Papagno, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CER Instituto Medico', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Córdoba', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Argentina', 'facility': 'CIDIIM', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'city': 'Mar del Plata', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Andres Alvarisqueta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Investigaciones Medicas Mar del Plata CIM', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}, {'zip': '080002', 'city': 'Barranquilla', 'state': 'Colombia', 'status': 'NOT_YET_RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Elias Forero, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro Integral De reumatologia del Caribe - CIRCARIBE SAS', 'geoPoint': {'lat': 10.96854, 'lon': -74.78132}}, {'city': 'Barranquilla', 'state': 'Colombia', 'status': 'NOT_YET_RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Juan Jaller, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Investigación Médico Asistencial S.A.S. - CIMEDICAL S.A.S.', 'geoPoint': {'lat': 10.96854, 'lon': -74.78132}}, {'city': 'Bogotá', 'state': 'Colombia', 'status': 'NOT_YET_RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Philipe Chalem, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Blue Care Salud SAS', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Bogotá', 'state': 'Colombia', 'status': 'NOT_YET_RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Patricia Velez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Investigacion en Reumatologia y Especialidades Medicas E.U. - CIREEM E.U', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Bogotá', 'state': 'Colombia', 'status': 'NOT_YET_RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Monica Terront, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Solano & Terront Servicios Médicos SAS - Unidad Integral de Endocrinología - UNIENDO', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'zip': '81-384', 'city': 'Gdynia', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Barbara Grabowicz-Waśko, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Futuremeds Gdynia', 'geoPoint': {'lat': 54.51889, 'lon': 18.53188}}, {'zip': '31-501', 'city': 'Krakow', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Piotr Rozpondek, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Krakowskie Centrum Medyczne', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '91-363', 'city': 'Lodz', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Katarzyna Bartnicka Maslowska, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Futuremeds Lodz', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '00-215', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Magda Dabrowska, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Futuremeds Warszawa Centrum', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '03-291', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Agnieszka Jurek Urbanowska, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Futuremeds Targowek', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '53-673', 'city': 'Wroclaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Paulina Ludziak, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Futuremeds Wroclaw', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Kyiv', 'state': 'Ukraine', 'status': 'RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Ivan Vyshnyvetshyy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CE "Hospital #1" of Zhytomyr City Council', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Kyiv', 'state': 'Ukraine', 'status': 'RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Nataliia Kozak, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical Center Universal Clinic "Oberig" of "Kapytal" LCC', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Vinnytsia', 'state': 'Ukraine', 'status': 'RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Maryna Ziabchenko, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'PSSE Medical Centre Pulse', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}], 'centralContacts': [{'name': 'Deborah Lium', 'role': 'CONTACT', 'email': 'clinicaltrials@angitiabio.com', 'phone': '818-862-2068'}], 'overallOfficials': [{'name': 'Ricardo Dent-Acosta, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Angitia Incorporated Limited'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Angitia Biopharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}