Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT07145918
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 258}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-08-22', 'studyFirstSubmitQcDate': '2025-08-22', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to approximately 74 days', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.'}, {'measure': 'Part A Only-Maximum Observed Plasma Concentration (Cmax) of Emraclidine', 'timeFrame': 'Up to approximately 24 days', 'description': 'Cmax of Emraclidine'}, {'measure': 'Part A Only-Time to Cmax (Tmax) of Emraclidine', 'timeFrame': 'Up to approximately 24 days', 'description': 'Tmax of Emraclidine'}, {'measure': 'Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine', 'timeFrame': 'Up to approximately 24 days', 'description': 'AUCt of Emraclidine'}, {'measure': 'Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine', 'timeFrame': 'Up to approximately 24 days', 'description': 'AUCtau of Emraclidine'}, {'measure': 'Part A Only-Maximum metabolite concentration (MRCmax) of Emraclidine', 'timeFrame': 'Up to approximately 21 days', 'description': 'MRCmax of Emraclidine'}, {'measure': 'Part A Only- Area under the metabolite concentration-time curve over the dosing interval (MRAUCtau) of Emraclidine', 'timeFrame': 'Up to approximately 21 days', 'description': 'MRAUCtau of Emraclidine'}, {'measure': 'Part A Only- Minimum plasma concentration (Cmin) of Emraclidine', 'timeFrame': 'Up to approximately 21 days', 'description': 'Cmin of Emraclidine'}, {'measure': 'Part A Only-Average plasma concentration (Cavg) of Emraclidine', 'timeFrame': 'Up to approximately 21 days', 'description': 'Cavg of Emraclidine'}, {'measure': 'Part A Only- Terminal Phase Elimination Half-Life (t1/2) of Emraclidine', 'timeFrame': 'Up to approximately 21 days', 'description': 'Terminal phase elimination half-life of Emraclidine'}, {'measure': 'Part A Only-Terminal elimination rate constant (λz) of Emraclidine', 'timeFrame': 'Up to approximately 21 days', 'description': 'λz of Emraclidine'}, {'measure': 'Part A Only-Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine', 'timeFrame': 'Up to approximately 21 days', 'description': 'CL/F of Emraclidine'}, {'measure': 'Part A Only-Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine', 'timeFrame': 'Up to approximately 21 days', 'description': 'Vz/F of Emraclidine'}, {'measure': 'Part A Only-Peak-to-trough ratio (PTR) of Emraclidine', 'timeFrame': 'Up to approximately 21 days', 'description': 'PTR of Emraclidine'}, {'measure': 'Part A Only- Accumulation ratio for Cmax (RacCmax) of Emraclidine', 'timeFrame': 'Up to approximately 21 days', 'description': 'RacCmax of Emraclidine'}, {'measure': 'Part A Only-Accumulation ratio for AUCta (RacAUCtau) of Emraclidine', 'timeFrame': 'Up to approximately 21 days', 'description': 'RacAUCta of Emraclidine'}, {'measure': 'Part A Only-Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364)', 'timeFrame': 'Up to approximately 24 days', 'description': 'Cmax of Metabolite (CV-0000364)'}, {'measure': 'Part A Only-Time to Cmax (Tmax) of Metabolite (CV-0000364)', 'timeFrame': 'Up to approximately 24 days', 'description': 'Tmax of Metabolite (CV-000036)'}, {'measure': 'Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-000036)', 'timeFrame': 'Up to approximately 24 days', 'description': 'AUCtau of Metabolite (CV-000036)'}, {'measure': 'Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036)', 'timeFrame': 'Up to approximately 24 days', 'description': 'AUCt of Metabolite (CV-000036)'}, {'measure': 'Part A Only-Maximum metabolite concentration (MRCmax) of Metabolite (CV-000036)', 'timeFrame': 'Up to approximately 21 days', 'description': 'MRCmax of Metabolite (CV-000036)'}, {'measure': 'Part A Only- Area under the metabolite concentration-time curve over the dosing interval (MRAUCtau) of Metabolite (CV-000036)', 'timeFrame': 'Up to approximately 21 days', 'description': 'MRAUCtau of Metabolite (CV-000036)'}, {'measure': 'Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score', 'timeFrame': 'Up to approximately week 6', 'description': 'PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS consists of 3 subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.'}], 'secondaryOutcomes': [{'measure': 'Part B Only-Change from Baseline in in Clinical Global Impression of Severity (CGIS) score', 'timeFrame': 'Up to approximately Week 6', 'description': 'CGIS is a single, clinician-reported item that measures the clinician\'s impression of a participant\'s current anxiety severity considering their total clinical experience with the patient population. The measure uses a 7-point Likert rating scale with responses ranging from "normal, to at all ill" (1) to "among the most extremely ill patients" (5), with higher scores indicating greater anxiety severity.'}, {'measure': 'Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score', 'timeFrame': 'Up to approximately 74 days', 'description': 'PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS consists of 3 subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.'}, {'measure': 'Part B Only-Change from Baseline in in Clinical Global Impression of Severity (CGIS) score', 'timeFrame': 'Up to approximately 53 days', 'description': 'CGIS is a single, clinician-reported item that measures the clinician\'s impression of a participant\'s current anxiety severity considering their total clinical experience with the patient population. The measure uses a 7-point Likert rating scale with responses ranging from "normal, to at all ill" (1) to "among the most extremely ill patients" (5), with higher scores indicating greater anxiety severity.'}, {'measure': 'Part B Only-Number of Participants achieving ≥ 30% improvement in PANSS total score', 'timeFrame': 'Up to approximately week 6', 'description': 'PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS consists of 3 subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.'}, {'measure': 'Part B Only-Number of Participants achieving remission (PANSS total score ≤ 60)', 'timeFrame': 'Up to approximately week 6', 'description': 'PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS consists of 3 subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'ABBV-1231'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M25-522', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Schizophrenia is a common and severe psychiatric illness characterized by extreme disturbances of cognition and thought, affecting language, perception and sense of self. This study will assess adverse events, change in disease activity, and how oral emraclidine moves through the body in adult participants with schizophrenia\n\nEmraclidine is an investigational drug being developed for the treatment of schizophrenia. Participants are placed in one of two parts, Part A or Part B, where each group will receive a different treatment. Participants will receive either oral emraclidine or placebo. Approximately 258 participants will be enrolled across roughly 32 sites in the United States.\n\nParticipants in Part A will be assigned to one of multiple ascending doses of emraclidine or placebo administered orally for 14 days or up to 21 days. Participants in Part B will receive Emraclidine or placebo administered orally for up to 42 days. Participants will be followed for 30 days after the last dose of the study drug.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI within 18 to 40 kg/m2 (inclusive of both values), and body weight \\> 50 kg (110 lbs).\n* (Part A only): Positive and Negative Syndrome Scale (PANSS) total score \\< 80 at Screening and at Baseline\n* (Part B only): Participant experiencing an acute exacerbation of psychotic symptoms with onset less than 2 months prior to Screening\n* (Part B only): Participant must have a PANSS total score from 80 to 120, inclusive, at Screening and at Baseline\n* (Part B only): Participant MUST have a score of ≥ 4 (moderate or greater) for ≥ 2 of the following PANSS Positive Scale items at Screening and at Baseline\n* (Part B only): Participant must have a Clinical Global Impression of Severity (CGIS) score ≥ 4 (at least moderately ill) at Screening and Baseline\n\nExclusion Criteria:\n\n* Any primary DSM-5 disorder other than schizophrenia (current nicotine use disorder and caffeine use disorder are allowed) within 12 months before Screening.\n* History of clozapine exposure.\n* History of treatment resistance to schizophrenia medications, defined as failure to respond to 2 or more adequate courses of pharmacotherapy (a minimum of 4 weeks at an adequate dose per the label) within the last 12 months'}, 'identificationModule': {'nctId': 'NCT07145918', 'briefTitle': 'A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'An Adaptive Two-part Randomized, Double Blind, Placebo-controlled Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Emraclidine in Participants With Schizophrenia', 'orgStudyIdInfo': {'id': 'M25-522'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emraclidine Part A', 'description': 'Participants will be assigned to received one of multiple ascending doses of oral emraclidine for 14 or up to 21 days, followed by a 30-day safety follow-up period.', 'interventionNames': ['Drug: Emraclidine']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo-Part A', 'description': 'Participants will be assigned to received one of multiple ascending doses of oral placebo for 14 or up to 21 days, followed by a 30-day safety follow-up period.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Emraclidine-Part B', 'description': 'Participants will receive oral emraclidine for 42 days followed by a 30-day safety follow-up period.', 'interventionNames': ['Drug: Emraclidine']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo-Part B', 'description': 'Participants will receive placebo for 42 days followed by a 30-day safety follow-up period.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Emraclidine', 'type': 'DRUG', 'description': 'Oral Tablets', 'armGroupLabels': ['Emraclidine Part A', 'Emraclidine-Part B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral Tablets', 'armGroupLabels': ['Placebo-Part A', 'Placebo-Part B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Coordinator', 'role': 'CONTACT', 'phone': '501-221-8681'}], 'facility': 'Woodland International Research Group /ID# 275747', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Collaborative Neuroscience Research - Garden Grove /ID# 273005', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '91206', 'city': 'Glendale', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Coordinator', 'role': 'CONTACT', 'phone': '818-254-1630'}], 'facility': 'California Clinical Trials Medical Group - Parexel /ID# 275751', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '20877', 'city': 'Gaithersburg', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Coordinator', 'role': 'CONTACT', 'phone': '301-251-4702'}], 'facility': 'Cbh Health - Gaithersburg /ID# 272932', 'geoPoint': {'lat': 39.14344, 'lon': -77.20137}}, {'zip': '08053', 'city': 'Marlton', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Coordinator', 'role': 'CONTACT', 'phone': '888-437-4104'}], 'facility': 'Cenexel Hassman Research Institute (Hri) /ID# 276128', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}, {'zip': '78754', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Coordinator', 'role': 'CONTACT', 'phone': '512-323-2622'}], 'facility': 'Community Clinical Research - Austin - Cross Park Drive /ID# 272977', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75080', 'city': 'Richardson', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Coordinator', 'role': 'CONTACT', 'phone': '214-396-4844'}], 'facility': 'Pillar Clinical Research - Richardson /ID# 275715', 'geoPoint': {'lat': 32.94818, 'lon': -96.72972}}], 'centralContacts': [{'name': 'ABBVIE CALL CENTER', 'role': 'CONTACT', 'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '844-663-3742'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.', 'accessCriteria': 'To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}