Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT07227818
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-13
First Post:
2025-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic 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'], 'maskingDescription': 'The initial Open-label Stabilization Period is open-label and non-randomized.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 560}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-11', 'studyFirstSubmitDate': '2025-11-11', 'studyFirstSubmitQcDate': '2025-11-11', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time From Randomization to Relapse', 'timeFrame': 'Up to approximately 30 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'NBI-1117568'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to evaluate NBI-1117568 compared with placebo in delaying relapse of symptoms of schizophrenia in adults who have a stable response after open-label treatment with NBI-1117568.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria.\n* Participant had the initial diagnosis of schizophrenia ≥1 year before screening.\n* Participant has had a positive response to ≥1 antipsychotic therapy (other than clozapine) at a therapeutic dose.\n\nKey Exclusion Criteria:\n\n* Participant has an unstable or poorly controlled medical condition or chronic disease (including history of neurological \\[including dementing illness, myasthenia gravis\\], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results) or malignancy within 30 days before Day 1.\n* Participant has any laboratory abnormalities suggestive of clinically significant, poorly managed, or unmanaged undiagnosed disease.\n* Participant has a history of clozapine treatment for treatment-resistant psychosis.\n* Participant has a history of a stay in a psychiatric inpatient facility for ≥30 consecutive days (other than for purely social reasons or due to participation in a different clinical trial) during the 90 days before screening.\n* Participant has initiated or increased intensity of nonpharmacological psychosocial therapeutic treatment within 3 weeks before screening or is expected to change throughout the length of the study.\n\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT07227818', 'briefTitle': 'Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurocrine Biosciences'}, 'officialTitle': 'A Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy of NBI-1117568 in Preventing Relapse of the Symptoms of Schizophrenia and to Assess the Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia', 'orgStudyIdInfo': {'id': 'NBI-1117568-SCZ3031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NBI-1117568', 'description': 'All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive NBI-1117568 during the Double-blind Treatment Period.', 'interventionNames': ['Drug: NBI-1117568']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive placebo matching NBI-1117568 during the Double-blind Treatment Period.', 'interventionNames': ['Drug: NBI-1117568', 'Drug: Placebo']}], 'interventions': [{'name': 'NBI-1117568', 'type': 'DRUG', 'description': 'Oral capsules', 'armGroupLabels': ['NBI-1117568', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral capsules', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Neurocrine Medical Information Call Center', 'role': 'CONTACT', 'email': 'medinfo@neurocrine.com', 'phone': '1-877-641-3461'}], 'overallOfficials': [{'name': 'Clinical Development Lead', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Neurocrine Biosciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurocrine Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}