Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT07301450
Status:
TEMPORARILY_NOT_AVAILABLE
Last Update Posted:
2025-12-24
First Post:
2025-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Expanded Access Program of Garetosmab in Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009221', 'term': 'Myositis Ossificans'}], 'ancestors': [{'id': 'D009220', 'term': 'Myositis'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'treatment': True}}, 'statusModule': {'overallStatus': 'TEMPORARILY_NOT_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-02-11', 'studyFirstSubmitQcDate': '2025-12-10', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Fibrodysplasia Ossificans Progressiva (FOP)']}, 'descriptionModule': {'briefSummary': 'The objective of this Expanded Access Program (EAP) is to provide garetosmab to patients with Fibrodysplasia Ossificans Progressiva (FOP) who have completed the double-blind treatment period of the parent study, OPTIMA (R2477-FOP-2175 \\[NCT05394116\\]), prior to marketing authorization approval, unless otherwise specified by country specific regulations for rare diseases.', 'detailedDescription': 'The program will enroll approximately up to 55 patients, globally.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Adult patients with FOP who must have completed the double-blind treatment period of the parent study OPTIMA (R2477-FOP-2175 \\[NCT05394116\\]), as defined in the protocol\n2. If the patient has progression of disease with Cumulative Analogue Joint Involvement Scale (CAJIS) \\>19 at the time of EAP enrollment, the case will require discussion and evaluation between the treating physician and EAP Medical Director to determine final eligibility\n\nKey Exclusion Criteria:\n\n1\\. Patients participating in OPTIMA who are considered by the treating physician as inappropriate for this program for any reason\n\nNOTE: Other protocol defined inclusion / exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT07301450', 'briefTitle': 'An Expanded Access Program of Garetosmab in Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'An Expanded Access Program of Garetosmab in Patients With Fibrodysplasia Ossificans Progressiva', 'orgStudyIdInfo': {'id': 'R2477-FOP-2081'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Garetosmab', 'type': 'DRUG', 'otherNames': ['REGN2477'], 'description': 'Administration as described in the protocol'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}