Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:10 PM
Study NCT ID:
NCT07489651
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RE104 Safety and Efficacy Study in Generalized Anxiety Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-18', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RE104 30 mg versus placebo change from Baseline at Week 4 in Hamilton Anxiety Rating Scale (HAM-A) total score', 'timeFrame': 'Week 4', 'description': 'The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety.'}], 'secondaryOutcomes': [{'measure': 'RE104 30 mg versus placebo changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)', 'timeFrame': 'Weeks 1, 2, 8 and 12', 'description': 'The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety.'}, {'measure': 'RE104 30 mg versus placebo percentage of participants with HAM-A response (≥50% reduction in score from Baseline)', 'timeFrame': 'Weeks 1, 2, 4, 8 and 12', 'description': 'The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety.'}, {'measure': 'RE104 30 mg versus placebo percentage of participants with HAM-A remission (total score ≤7)', 'timeFrame': 'Day 1 and Weeks 1, 2, 4, 8 and 12', 'description': 'The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety.'}, {'measure': 'RE104 30 mg versus placebo change from Baseline at Weeks 1, 2, 4, 8, and 12 in Hospital Anxiety and Depression Scale (HADS) depression subscore', 'timeFrame': 'Weeks 1, 2, 4, 8 and 12', 'description': 'The Hospital Anxiety and Depression Scale (HADS) is a self-reported scale measure the severity of depression and anxiety in patients with comorbid medical conditions. The scale consists of 14 items (7 for anxiety and 7 for depression), with a score ranging between 0 and 21 for the anxiety and depression subscales.'}, {'measure': 'RE104 30 mg versus placebo incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.', 'timeFrame': 'From dosing through study completion (post-dose follow-up is for 12 weeks)', 'description': 'A treatment-emergent adverse event (TEAE) is defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a study drug.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GAD'], 'conditions': ['Generalized Anxiety Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces anxiety symptoms in participants with Generalized Anxiety Disorder (GAD) as compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has Generalized Anxiety Disorder as defined by DSM-5-TR\n* Is on stable use of antidepressants (i.e., SSRIs or SNRIs) or psychotherapy, or is willing to delay the use until the end of study\n* If female is not pregnant or planning to become pregnant. If male is not planning to make a partner pregnant.\n* Is willing and able to comply with the conditions and requirements of the study\n\nExclusion Criteria:\n\n* Has a significant risk of suicide\n* Has an active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder\n* Has other concurrent psychiatric disorders that is the primary disorder.\n* Has other medically significant conditions rendering unsuitability for the study\n* Has used or will need to use prohibited medications or therapies\n* Has a known sensitivity or intolerance to study intervention or potential rescue medications'}, 'identificationModule': {'nctId': 'NCT07489651', 'briefTitle': 'RE104 Safety and Efficacy Study in Generalized Anxiety Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Reunion Neuroscience Inc'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Generalized Anxiety Disorder', 'orgStudyIdInfo': {'id': 'RE104-203-GAD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'A single subcutaneous injection of 0.9% sodium chloride for injection', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '30 mg RE104', 'description': 'A single subcutaneous injection of 30 mg RE104 for Injection', 'interventionNames': ['Drug: RE104 for Injection']}], 'interventions': [{'name': 'RE104 for Injection', 'type': 'DRUG', 'description': 'Single, subcutaneous dose of RE104 for Injection', 'armGroupLabels': ['30 mg RE104']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Single, subcutaneous dose of 0.9% sodium chloride for injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mark Pollack Chief Medical Officer, M.D.', 'role': 'CONTACT', 'email': 'info@reunionneuro.com', 'phone': '1-888-880-REUN'}], 'overallOfficials': [{'name': 'Mark Pollack, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Reunion Neuroscience Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reunion Neuroscience Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}