Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT06984627
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006111', 'term': 'Graves Disease'}], 'ancestors': [{'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-14', 'studyFirstSubmitDate': '2025-05-14', 'studyFirstSubmitQcDate': '2025-05-14', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change from baseline in FT4 levels', 'timeFrame': 'At Week16', 'description': 'Free thyroxine'}], 'secondaryOutcomes': [{'measure': 'Percent change from baseline in FT3 levels', 'timeFrame': 'At Week16', 'description': 'Free triiodothyronine'}, {'measure': 'Proportion of participants with FT4 levels within normal limits', 'timeFrame': 'At Week16'}, {'measure': 'Proportion of participants with FT3 levels within normal limits', 'timeFrame': 'At Week16'}, {'measure': 'Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and withdrawals due to TEAEs during the study period', 'timeFrame': 'Up to week 20'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Graves' Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.trialsummaries.com/Study/StudyDetails?id=26684&tenant=MT_SNY_9011', 'label': 'PDY18663 Plain Language Results Summary'}]}, 'descriptionModule': {'briefSummary': "This is a parallel group, Phase 2, 2-arm study to measure the treatment effect and safety of rilzabrutinib dose 1 or rilzabrutinib dose 2 in participants with Graves' disease, with and without Graves' orbitopathy, aged 18 years or older.\n\nStudy details include:\n\n* Screening period (up to 4 weeks).\n* Treatment period (up to 16 weeks).\n* Follow-up period (4 weeks). The number of visits will be up to 13."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants who have a confirmed diagnosis of Graves' disease with active hyperthyroidism, with or without active Graves' orbitopathy at the time of screening.\n* A subset of participants will have a diagnosis of active Graves' orbitopathy, as confirmed by ophthalmic exam at screening and a clinical activity score (CAS) ≥3 for the most severely affected eye, and associated with one or more of the following: lid retraction ≥2 mm, moderate or severe soft tissue involvement, proptosis ≥2 mm, and/or intermittent or constant diplopia.\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n* History of hyperthyroidism not caused by Graves' disease (eg, hyperthyroidism due to toxic multinodular goiter, autonomous thyroid nodule, acute inflammatory thyroiditis).\n* History of thyroid storm or at high risk of developing thyroid storm as determined by evaluating clinician.\n* Enlarged thyroid goiter causing upper airway obstruction and/or requiring surgical intervention during the study period.\n* For participant with Graves' orbitopathy, requires immediate surgical ophthalmological intervention or is planning corrective surgery/irradiation during the course of the study.\n* Sight threatening Graves' orbitopathy or decreased visual acuity due to optic neuropathy within the last 6 months.\n* Corneal decompensation unresponsive to medical management.\n* Onset of Graves' orbitopathy symptoms \\>9 months prior to baseline. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT06984627', 'briefTitle': "A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': "An Open-label Phase 2 Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease", 'orgStudyIdInfo': {'id': 'PDY18663'}, 'secondaryIdInfos': [{'id': '2025-521023-75', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': 'U1111-1316-0208', 'type': 'OTHER_GRANT', 'domain': 'ICTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rilzabrutinib dose 1', 'description': 'Rilzabrutinib', 'interventionNames': ['Drug: Rilzabrutinib dose 1']}, {'type': 'EXPERIMENTAL', 'label': 'Rilzabrutinib dose 2', 'description': 'Rilzabrutinib', 'interventionNames': ['Drug: Rilzabrutinib dose 2']}], 'interventions': [{'name': 'Rilzabrutinib dose 1', 'type': 'DRUG', 'otherNames': ['SAR444671'], 'description': 'Pharmaceutical form:Tablet-Route of administration:Oral', 'armGroupLabels': ['Rilzabrutinib dose 1']}, {'name': 'Rilzabrutinib dose 2', 'type': 'DRUG', 'otherNames': ['SAR444671'], 'description': 'Pharmaceutical form:Tablet-Route of administration:Oral', 'armGroupLabels': ['Rilzabrutinib dose 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4L7', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Investigational Site Number : 1240003', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V3T 2V6', 'city': 'Surrey', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Investigational Site Number : 1240002', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Investigational Site Number : 1240001', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': '45147', 'city': 'Essen', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Investigational Site Number : 2760002', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60590', 'city': 'Frankfurt', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Investigational Site Number : 2760001', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '20122', 'city': 'Milan', 'state': 'Milano', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Investigational Site Number : 3800001', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '90127', 'city': 'Palermo', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Investigational Site Number : 3800003', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '56126', 'city': 'Pisa', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Investigational Site Number : 3800002', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Catalunya [Cataluña]', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Investigational Site Number : 7240002', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Investigational Site Number : 7240001', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': 'MK6 5LD', 'city': 'Milton Keynes', 'state': 'Buckinghamshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Investigational Site Number : 8260003', 'geoPoint': {'lat': 52.04172, 'lon': -0.75583}}, {'zip': 'NE2 4HH', 'city': 'Newcastle upon Tyne', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Investigational Site Number : 8260001', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'centralContacts': [{'name': 'Trial Transparency email recommended (Toll free for US & Canada)', 'role': 'CONTACT', 'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'phoneExt': 'option 6'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}