Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-03-28 @ 7:21 AM
Study NCT ID:
NCT06510504
Status:
COMPLETED
Last Update Posted:
2025-10-24
First Post:
2024-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of BNC210 in Acute, As-needed Treatment of Anxiety in Social Anxiety Disorder - 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072861', 'term': 'Phobia, Social'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 370}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2024-07-15', 'studyFirstSubmitQcDate': '2024-07-15', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Units of Distress Scale (SUDS)', 'timeFrame': '1 day', 'description': 'The Subjective Units of Distress Scale (SUDS) is a self reported measure of the intensity of distress currently experienced by an individual. The range is 0-100, with a higher score indicating a higher level of anxiety/greater distress.'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impressions-Severity (CGI-S)', 'timeFrame': '1 day', 'description': "The CGI-S measures overall disease severity of the participant's symptoms as scored by a clinician. Severity is rated from 1 (normal, not at all ill) to 7 (among the most extremely ill of patients) with a higher score indicating a higher level of disease severity."}, {'measure': 'Patient Global Impressions-Improvement (PGI-I)', 'timeFrame': '1 day', 'description': "The PGI-I is a patient self-reported counterpart of the CGI designed to assess the patient's impression of their perceived change in overall symptoms. Improvement is rated from 1 (very much improved) to 7 (very much worse) with a higher score indicating a higher level of disease severity."}, {'measure': 'State-Trait Anxiety Inventory (State Component; STAI-State)', 'timeFrame': '1 day', 'description': 'The State-Trait Anxiety Inventory (State component; STAI-State) is a self reported measure of subjective anxiety at the time of questionnaire completion. The range is 0-80 with a higher total score indicating a higher level of anxiety.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Social Anxiety Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://theaffirm1study.com/', 'label': 'Study information and pre-screening portal for potential participants'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the effect of a single, acute dose of BNC210 compared to placebo on reducing the severity of anxiety provoked by a behavioral assessment task and measured using the Subjective Units of Distress Scale (SUDS) in adult patients with social anxiety disorder.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled, 2-arm, parallel-group, multi-center study. Participants will attend a Screening Visit to confirm eligibility and then return to the clinic within 21 days to be randomized into the study. Randomized participants will receive a single dose of their allocated study medication (225 mg BNC210 or placebo) and approximately 1 hour later participate in a behavioral assessment task. After 1 week, a safety follow-up assessment will be conducted by phone/video conference.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A current diagnosis of social anxiety disorder as defined in the DSM-5.\n* A Liebowitz Social Anxiety Scale total score of ≥60.\n* Suitable contraception use in line with protocol requirements.\n* Ability to swallow tablets.\n\nExclusion Criteria:\n\n* History of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorders, anorexia or bulimia, body dysmorphic disorder, PTSD, autism-spectrum disorder or obsessive-compulsive disorder, or any other Axis I or II disorder which is currently the primary focus of treatment over social anxiety disorder.\n* Hamilton Rating Scale for Depression score of ≥18.\n* Moderate or severe alcohol-use disorder, or any other substance-use disorder (any severity) in the past 12 months.\n* Use of psychotropic medications within 30 days of screening. Daily use of benzodiazepines within 90 days of screening.\n* Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk.'}, 'identificationModule': {'nctId': 'NCT06510504', 'acronym': 'AFFIRM-1', 'briefTitle': 'Efficacy of BNC210 in Acute, As-needed Treatment of Anxiety in Social Anxiety Disorder - 1', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bionomics Limited'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind, 2-arm, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of BNC210 for the Acute, As-needed Treatment of Anxiety in Adults With Social Anxiety Disorder', 'orgStudyIdInfo': {'id': 'BNC210.014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '225 mg BNC210', 'interventionNames': ['Drug: 225 mg BNC210']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': '225 mg BNC210', 'type': 'DRUG', 'description': '225 mg BNC210', 'armGroupLabels': ['225 mg BNC210']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91316', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '95124', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '92591', 'city': 'Temecula', 'state': 'California', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 33.49364, 'lon': -117.14836}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33319', 'city': 'Lauderhill', 'state': 'Florida', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 26.14036, 'lon': -80.21338}}, {'zip': '33016', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02131', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}, {'zip': '11229', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '28211', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '19063', 'city': 'Media', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 39.91678, 'lon': -75.38769}}, {'zip': '78737', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'AFFIRM-1 Study Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bionomics Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}