Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-31 @ 1:30 PM
Study NCT ID:
NCT06727604
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2024-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2024-12-09', 'studyFirstSubmitQcDate': '2024-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants who are euthyroid (local laboratory T3 [Total T3 or FT3], FT4, and TSH values within normal limits) and off ATD at Week 26', 'timeFrame': 'Week 26'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants who are euthyroid and off ATD at Week 52', 'timeFrame': 'Week 52'}, {'measure': 'Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 52', 'timeFrame': 'Week 52'}, {'measure': 'Percentage of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 52 to Week 78', 'timeFrame': 'Week 78'}, {'measure': 'Percentage of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 52 to Week 104', 'timeFrame': 'Week 104'}, {'measure': 'Percentage of participants who have a TRAb value a specified amount and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 26 to Week 52', 'timeFrame': 'Week 52'}, {'measure': 'Percentage of participants who have a TRAb value a specific amount and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 26 to Week 78', 'timeFrame': 'Week 78'}, {'measure': 'Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline', 'timeFrame': 'Week 2'}, {'measure': 'Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN at Week 4 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline', 'timeFrame': 'Week 4'}, {'measure': 'Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 26', 'timeFrame': 'Week 26'}, {'measure': 'Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 26', 'timeFrame': 'Week 26'}, {'measure': 'Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 52', 'timeFrame': 'Week 52'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IMVT-1402', 'Anti Thyroid Drug', 'Hyperthyroidism', 'Autoimmune thyroid disease'], 'conditions': ["Graves' Disease"]}, 'descriptionModule': {'briefSummary': "This is a study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.\n\nThe primary objective of this study is to evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (total triiodothyronine \\[T3\\] or free triiodothyronine \\[FT3\\]), free thyroxine (FT4), thyroid-stimulating hormone (TSH), and ATD dose at Week 26."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have documented diagnosis of GD.\n* Have a TSH value \\< 0.1 mIU/L as assessed by the local laboratory at the Screening Visit.\n* Meet one of the following at the Screening Visit:\n\n * Have been on ATD for ≥ 3 months in the period immediately preceding the Screening Visit and both of the following:\n\n * Are on ATD at the Screening Visit with an ATD dose of ≥ 20 mg/day methimazole or equivalent for the 4-week period immediately preceding the Screening Visit.\n * Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization.\n * Have been on ATD for ≥ 6 months in the period immediately preceding the Screening Visit and all of the following:\n\n * Have been treated with ≥ 15 mg/day methimazole or equivalent at any point during the participant's treatment history.\n * Are on ATD at the Screening Visit with an ATD dose a specified amount of methimazole or equivalent for the 4-week period immediately preceding the Screening Visit.\n * Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization.\n\nAdditional inclusion criteria are defined in the protocol.\n\nExclusion Criteria:\n\n* Have previously been treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.\n* Have a T3 (Total T3 or FT3, as available and per standard of care at local laboratory) or FT4 value \\< lower limit of normal (LLN) as assessed by the local laboratory at the Screening Visit.\n* Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within 6 weeks of the Screening Visit.\n* Have a history of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter) and/or history of thyroid storm within 6 months of the Screening Visit.\n* Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.\n* Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation.\n\nAdditional exclusion criteria are defined in the protocol."}, 'identificationModule': {'nctId': 'NCT06727604', 'briefTitle': "A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Immunovant Sciences GmbH'}, 'officialTitle': "A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease", 'orgStudyIdInfo': {'id': 'IMVT-1402-2502'}, 'secondaryIdInfos': [{'id': '2024-516020-33-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 Period 1 and 2: IMVT-1402', 'interventionNames': ['Drug: IMVT-1402']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 Period 1 and 2: IMVT-1402', 'interventionNames': ['Drug: IMVT-1402']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 Period 1: IMVT-1402 and Period 2: Placebo', 'interventionNames': ['Drug: IMVT-1402']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 3 Period 1 and 2: Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'IMVT-1402', 'type': 'DRUG', 'description': '600 mg SC QW for 52 weeks', 'armGroupLabels': ['Group 1 Period 1 and 2: IMVT-1402', 'Group 2 Period 1 and 2: IMVT-1402']}, {'name': 'IMVT-1402', 'type': 'DRUG', 'description': '600 mg SC QW for 26 weeks followed by Placebo SC QW for 26 weeks', 'armGroupLabels': ['Group 2 Period 1: IMVT-1402 and Period 2: Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'SC QW for 52 weeks', 'armGroupLabels': ['Group 3 Period 1 and 2: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1032', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85015', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1036', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1001', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1034', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '91321', 'city': 'Santa Clarita', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1035', 'geoPoint': {'lat': 34.39166, 'lon': -118.54259}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1005', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Site Number - 1006', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'status': 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