SchizophreniaPhase 3UNITE-001NCT05919823
A Study to Assess the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects With DSM-5 Schizophrenia
A Phase 3 study testing Xanomeline and Trospium Chloride Capsules in people with Schizophrenia, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 28 sites in China.
Trial summary
A Phase 3, Multicenter, Two-part Study with a 5-week Double-blind Part (Randomized, Parallel-group, Placebo-controlled) followed by a 12-week Open-label Extension Part, to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects with DSM-5 Schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Xanomeline and Trospium Chloride Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 28 sitesChina
- Study dates
- 29 May 2023to 9 Dec 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is Chinese national, aged 18 to 65 years, inclusive, at screening.
- Subject is capable of providing written informed consent.
- Subject has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 and MINI.
- Subject is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening.
- The subject requires hospitalization for this acute exacerbation or relapse of psychotic symptoms at screen.
- If already an inpatient at screening, hospitalization has to be ≤2 weeks for the current exacerbation at the time of screening.
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- PANSS total score between 80 and 120,inclusive, with a scores of ≥4 (moderate or greater) for ≥2 of the following Positive Scale (P) items:
- Item 1 (P1; delusions)
- Item 2 (P2; conceptual disorganization)
- Item 3 (P3; hallucinatory behavior)
- Item 6 (P6; suspiciousness/persecution)
- Subjects with no change (improvement) in PANSS total score between screening and baseline (Day -1) of more than 20%.
- Subject has a CGI-S score of ≥4 at screening and baseline (Day -1) visits.
- Subject will have been off lithium therapy for at least 2 weeks before baseline and free of all oral antipsychotic medications for at least 5 half-lives or 1 week, whichever is longer, before baseline (Day -1).
- Subjects taking a long-acting injectable antipsychotic could not have received a dose of medication for at least 12 weeks (24 weeks for INVEGA TRINZA®) before baseline visit (Day -1).
- Subject is able to be confined to an inpatient setting for the duration of the 5-week double-blind part of the study, follow instructions, and comply with the protocol requirements.
- Body mass index of 18 to 40 kg/m2, inclusive.
- Subject resides in a stable living situation and is anticipated to return to that same stable living situation after discharge, in the opinion of the investigator.
- Subject has an identified reliable informant. An informant is needed at the screening and baseline visits as well as at the end of the study for relevant assessments (site staff may act as informant while the subject is an inpatient). An informant may not be necessary if the subject has been a patient of the investigator for ≥1 year.
- Women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP must be willing and able to adhere to the contraception guidelines.
Who cannot join
- Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using MINI version 7.0.2 at screening).
- Subjects who are newly diagnosed or are experiencing their first treated episode of schizophrenia.
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
- Subjects with human immunodeficiency virus (HIV), cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or liver function test results.
- History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
- History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
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- Risk for suicidal behavior during the study as determined by the investigator's clinical assessment and C-SSRS.
- Clinically significant abnormal findings on the physical examination, medical history, electrocardiogram, or clinical laboratory results at screening that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
- Subjects are receiving or have recently received (within 5 half-lives or 1 week, whichever is longer, before baseline [Day -1]) oral antipsychotic medications; monoamine oxidase inhibitors; anticonvulsants (e.g., lamotrigine, valproate); tricyclic antidepressants (e.g., imipramine, desipramine); selective serotonin reuptake inhibitors; or any other psychoactive medications except for as-needed anxiolytics (e.g., lorazepam, chloral hydrate).
- Subjects are receiving or have recently received (within 1 week before baseline [Day -1]) metformin.
- Pregnant, lactating, or less than 3 months postpartum.
- In the opinion of the investigator and/or Sponsor, subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the investigator and/or Sponsor, may compromise the safety of the subject or affect his/her ability to adhere to the protocol visit schedule or fulfill visit requirements.
- Subject has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days before screening.
- Subject has a history of treatment resistance to schizophrenia medications defined as failure to respond to 2 adequate courses of pharmacotherapy (a minimum of 4 weeks at an adequate dose per the label) or has required clozapine within the last 12 months.
- Subjects with prior exposure to KarXT.
- Subjects who experienced any significant adverse effects due to trospium chloride.
- Participation in another clinical study within 3 months before screening in which the subject received an experimental or investigational drug agent.
- Significant risk of violent or destructive behavior.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
China28 sites
The Sixth People's Hosptial of Hebei Province
Baoding, Hebei, 071051
Beijing Anding Hospital Capital Medical University
Beijing, Beijing Municipality, 100035
Peking University Sixth Hospital
Beijing, Beijing Municipality, 100083
Beijing HuiLongGuan Hospital
Changping, Beijing Municipality, 100096
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
The Fourth People's Hospital of Chengdu
Chengdu, Sichuan, 610036
Chongqing 11th People's Hospital
Chongqing, Chongqing Municipality, 400047
Daqing City Third Hospital
Daqing, Heilongjiang, 163161
Guangyuan Mental Health Center
Guangyuan, Sichuan, 628033
The Affiliated Brain Hospital of Guangzhou Medical University
Guanzhou, Guangdong, 510370
Hangzhou Seventh People's Hospital
Hangzhou, Zhejiang, 310013
Anhui Mental Health Center
Hefei, Anhui, 230022
HuZhou Third Municipal Hospital
Huzhou, Zhejiang, 313028
Chongqing Mental Health Center
Jiangbei, Chongqing Municipality, 401147
Shandong Mental Health Center
Jinan, Shandong, 250014
Shandong Daizhuang Hospital
Jining, Shandong, 272009
Jiangxi Mental Health Center
Nanchang, Jiangxi, 330027
Ningbo Kangning Hospital
Ningbo, Zhejiang, 315002
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200032
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, 300382
Urumqi Fourth People's Hospital
Ürümqi, Xinjiang, 830002
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325015
Wuhan Mental Health Center
Wuhan, Hubei, 430000
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430064
Wuhu Hospital of Beijing Anding Hospital
Wuhu, Anhui, 241000
Wuxi Mental Health Center
Wuxi, Jiangsu, 214151
Mental Health Center of Xi'an City
Xi'an, Shaanxi, 710061
Zhumadian Second People's Hospital
Zhumadian, Henan, 463001
About this study
Official title: A Phase 3, Multicenter, Two-part Study With a 5-week Double-blind Part (Randomized, Parallel-group, Placebo-controlled) Followed by a 12-week Open-label Extension Part, to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects With DSM-5 Schizophrenia
A Phase 3, Multicenter, Two-part Study with a 5-week Double-blind Part (Randomized, Parallel-group, Placebo-controlled) followed by a 12-week Open-label Extension Part, to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects with DSM-5 Schizophrenia
- Conditions
- Schizophrenia
- Being tested
- Xanomeline and Trospium Chloride Capsules, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xanomeline and Trospium Chloride CapsulesDrug
Also called KarXT
Oral xanomeline 50 mg/trospium 20 mg BID on days 1-2 followed by xanomeline 100 mg/trospium 20 mg BID on days 3-7. The dose is increased to xanomeline 125 mg/trospium 30 mg BID on days 8-35 unless the subject is experiencing adverse events from the xanomeline 100 mg/ trospium 20 mg dose. Subjects who were increased to xanomeline 125 mg/trospium 30 mg will have the option to return to xanomeline 100 mg/ trospium 20 mg depending on clinical response and tolerability.
PlaceboDrug
Placebo Capsules
| Study group | Role | What they receive |
|---|---|---|
| KarXT | Experimental | Not described Receives: Drug: Xanomeline and Trospium Chloride Capsules |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Week 5 of the Double-Blind Period
PANSS Total Score is a clinical tool used to measure the severity of symptoms in individuals with schizophrenia. It includes 30 items divided into three subscales:
Positive Symptoms (e.g., hallucinations, delusions) Negative Symptoms (e.g., social withdrawal, lack of motivation) General Psychopathology (e.g., anxiety, depression) Each item is rated from 1 (absent) to 7 (extreme), resulting in a total score range from 30 to 210.
Higher PANSS Total Scores indicate more severe symptoms and worse clinical outcomes.
Baseline is defined as last non-missing assessment prior to the first dose of study drug.
Measured: At Baseline and at Week 5 of the Double-Blind Period
Secondary outcomes (24)
Change From Baseline in Positive Symptom Score of the Positive and Negative Syndrome Scale (PANSS) at Week 5 of the Double-Blind Period
The PANSS Positive Symptom Score assesses the severity of positive symptoms in schizophrenia, such as hallucinations and delusions. It includes 7 items: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Each item is rated from 1 (absent) to 7 (extreme), for a total score range of 7 to 49. Higher scores indicate more severe symptoms and worse clinical outcomes.
Baseline is defined as last non-missing assessment prior to the first dose of study drug.
Measured: At Baseline and at Week 5 of the Double-Blind Period
Change From Baseline in Negative Symptom Score of the Positive and Negative Syndrome Scale (PANSS) at Week 5 of the Double-Blind Period
The Positive and Negative Syndrome Scale (PANSS) Negative Symptom Score assesses the severity of negative symptoms in schizophrenia, such as emotional withdrawal and reduced motivation. It includes 7 items: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity, and stereotyped thinking. Each item is rated from 1 (absent) to 7 (extreme), for a total score range of 7 to 49. Higher scores indicate more severe symptoms and worse outcomes.
Baseline is defined as last non-missing assessment prior to the first dose of study drug.
Measured: At Baseline and at Week 5 of the Double-Blind Period
Change From Baseline in Negative Marder Factor Score of the Positive and Negative Syndrome Scale (PANSS) at Week 5 of the Double-Blind Period
The Negative Marder Factor Score is subset of PANSS items used to evaluate negative symptoms based on a five-factor model. It includes 7 items: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of spontaneity, motor retardation, and active social avoidance. Each item is rated from 1 to 7. Higher scores reflect greater severity of negative symptoms and poorer clinical outcomes. PANSS total score is the sum of all 30 items with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. The PANSS Total Score is then the sum of the positive, negative, and general psychopathology symptom scores. Baseline is defined as last non-missing assessment prior to the first dose of study drug.
Measured: At Baseline and at Week 5 of the Double-Blind Period
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score at Week 5 of the Double-Blind Period
The CGI-S Score is a clinician-rated scale used to assess the severity of a patient's mental illness at a given time. It ranges from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients). The score reflects the clinician's overall impression based on observed symptoms, behavior, and functioning. Higher scores indicate greater illness severity and worse clinical status.
Baseline is defined as last non-missing assessment prior to the first dose of study drug.
Measured: At Baseline and at Week 5 of the Double-Blind Period
Percentage of PANSS Responders (≥30% Change in PANSS Total Score From Baseline) at Week 5 of the Double-Blind Period
PANSS Total Score is a clinical tool used to measure the severity of symptoms in individuals with schizophrenia. It includes 30 items divided into three subscales:
Positive Symptoms (e.g., hallucinations, delusions) Negative Symptoms (e.g., social withdrawal, lack of motivation) General Psychopathology (e.g., anxiety, depression) Each item is rated from 1 (absent) to 7 (extreme), resulting in a total score range from 30 to 210.
Higher PANSS Total Scores indicate more severe symptoms and worse clinical outcomes.
Baseline is defined as last non-missing assessment prior to the first dose of study drug.
Measured: At Baseline and at Week 5 of the Double-Blind Period
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Week 12 of the Open-Label Period
PANSS Total Score is a clinical tool used to measure the severity of symptoms in individuals with schizophrenia. It includes 30 items divided into three subscales:
Positive Symptoms (e.g., hallucinations, delusions) Negative Symptoms (e.g., social withdrawal, lack of motivation) General Psychopathology (e.g., anxiety, depression) Each item is rated from 1 (absent) to 7 (extreme), resulting in a total score range from 30 to 210.
Higher PANSS Total Scores indicate more severe symptoms and worse clinical outcomes.
Study baseline is defined as last non-missing assessment prior to the first dose of study drug. Open-label baseline is defined as last non-missing assessment prior to the first dose of study drug in the open-label part.
Measured: At Baseline and at Week 12 of the Open-Label Period
Change From Baseline in Positive Symptom Score of the Positive and Negative Syndrome Scale (PANSS) at Week 12 of the Open-Label Period
The PANSS Positive Symptom Score assesses the severity of positive symptoms in schizophrenia, such as hallucinations and delusions. It includes 7 items: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Each item is rated from 1 (absent) to 7 (extreme), for a total score range of 7 to 49. Higher scores indicate more severe symptoms and worse clinical outcomes.
Study baseline is defined as last non-missing assessment prior to the first dose of study drug. Open-label baseline is defined as last non-missing assessment prior to the first dose of study drug in the open-label part.
Measured: At Baseline and at Week 12 of the Open-Label Period
Change From Baseline in Negative Symptom Score of the Positive and Negative Syndrome Scale (PANSS) at Week 12 of the Open-Label Period
The Positive and Negative Syndrome Scale (PANSS) Negative Symptom Score assesses the severity of negative symptoms in schizophrenia, such as emotional withdrawal and reduced motivation. It includes 7 items: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity, and stereotyped thinking. Each item is rated from 1 (absent) to 7 (extreme), for a total score range of 7 to 49. Higher scores indicate more severe symptoms and worse outcomes.
Study baseline is defined as last non-missing assessment prior to the first dose of study drug. Open-label baseline is defined as last non-missing assessment prior to the first dose of study drug in the open-label part.
Measured: At Baseline and at Week 12 of the Open-Label Period
Change From Baseline in Negative Marder Factor Score of the Positive and Negative Syndrome Scale (PANSS) at Week 12 of the Open-Label Period
The Negative Marder Factor Score is subset of PANSS items used to evaluate negative symptoms based on a five-factor model. It includes 7 items: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of spontaneity, motor retardation, and active social avoidance. Each item is rated from 1 to 7. Higher scores reflect greater severity of negative symptoms and poorer clinical outcomes.
Study baseline is defined as last non-missing assessment prior to the first dose of study drug. Open-label baseline is defined as last non-missing assessment prior to the first dose of study drug in the open-label part.
Measured: At Baseline and at Week 12 of the Open-Label Period
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score at Week 12 of the Open-Label Period
The CGI-S Score is a clinician-rated scale used to assess the severity of a patient's mental illness at a given time. It ranges from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients). The score reflects the clinician's overall impression based on observed symptoms, behavior, and functioning. Higher scores indicate greater illness severity and worse clinical status.
Study baseline is defined as last non-missing assessment prior to the first dose of study drug. Open-label baseline is defined as last non-missing assessment prior to the first dose of study drug in the open-label part.
Measured: At Baseline and at Week 12 of the Open-Label Period
Percentage of PANSS Responders (≥30% Change in PANSS Total Score From Baseline) at Week 12 of the Open-Label Period
PANSS Total Score is a clinical tool used to measure the severity of symptoms in individuals with schizophrenia. It includes 30 items divided into three subscales:
Positive Symptoms (e.g., hallucinations, delusions) Negative Symptoms (e.g., social withdrawal, lack of motivation) General Psychopathology (e.g., anxiety, depression) Each item is rated from 1 (absent) to 7 (extreme), resulting in a total score range from 30 to 210.
Higher PANSS Total Scores indicate more severe symptoms and worse clinical outcomes.
Study baseline is defined as last non-missing assessment prior to the first dose of study drug. Open-label baseline is defined as last non-missing assessment prior to the first dose of study drug in the open-label part.
Measured: At Baseline and at Week 12 of the Open-Label Period
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Study Drug Withdrawal
Adverse Event (AE):
An AE is any unfavorable and unintended sign, symptom, or disease that occurs in a participant during a clinical trial, regardless of whether it is related to the study treatment. This includes new conditions or worsening of pre-existing ones.
Serious Adverse Event (SAE):
An SAE is an AE that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, causes persistent or significant disability/incapacity, or leads to a congenital anomaly/birth defect. Other events may be considered serious if they require medical intervention to prevent one of these outcomes.
Measured: From first dose until study completion (up to approximately 18 weeks)
Number of Participants With Orthostatic Vital Sign Events
Orthostatic vital signs included blood pressure and heart rate. A participant having sustained orthostatic event is defined as the participant experienced at least one orthostatic event for at least 3 consecutive visits.
Measured: From first dose until study completion (up to approximately 18 weeks)
Number of Participants With Elevated Liver Function Test Results
ULN = upper limit of normal range.; DB = Double-blind period; OL = Open-label period. Hy's law is defined as an elevated alanine aminotransferase level (>3xULN) or an elevated aspartate aminotransferase (>3xULN) in combination with alkaline phosphatase <2xULN and elevated total bilirubin (>2 x ULN). Study baseline is defined as last non-missing assessment prior to the first dose of study drug. Open-label baseline is defined as last non-missing assessment prior to the first dose of study drug in the open-label part.
Measured: At study baseline, Day 21 DB, Day 35 DB, open-label baseline, Day 14 OL, Day 84 OL, and end of study visit (up to approximately 18 weeks)
Number of Participants With Elevated Metabolic Syndrome Parameters
ULN = Upper limit of normal; DB = Double-blind period; OL = Open-label period. Study baseline is defined as last non-missing assessment prior to the first dose of study drug. Open-label baseline is defined as last non-missing assessment prior to the first dose of study drug in the open-label part.
Measured: At study baseline, Day 21 DB, Day 35 DB, open-label baseline, Day 14 OL, Day 84 OL, and end of study visit (up to approximately 18 weeks)
Number of Participants With Abnormal Electrocardiogram (ECG) Results
Anytime post-baseline includes all assessments from the first dose of study drug until end of study visit in double-blind/open-label part, including unscheduled assessments. Study baseline is defined as last non-missing assessment prior to the first dose of study drug. Open-label baseline is defined as last non-missing assessment prior to the first dose of study drug in the open-label part.
Measured: At study baseline and up to study completion (up to approximately 18 weeks)
Number of Participants With Suicidal Ideation as Defined by a Columbia-Suicide Severity Rating Scale (C-SSRS) Ideation Score of 1 or Greater
The C-SSRS is a clinician- or self-administered questionnaire assessing suicidal ideation and behavior. It rates ideation severity from 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent). It also records the presence or absence of suicidal behaviors, including actual, interrupted, or aborted attempts, and preparatory acts. The highest level of ideation or most severe behavior reported is used to determine suicide risk; higher ideation scores or any suicidal behavior indicate greater risk. Baseline is the last non-missing assessment before first study drug dose.
Measured: From first dose to study completion (up to approximately 18 weeks)
Number of Participants With Clinically Meaningful Changes in Simpson-Angus Scale (SAS), Barnes Akathisia Rating Scale (BARS), and Abnormal Involuntary Movement Scale (AIMS) Results
Treatment-emergent parkinsonism is defined as Simpson-Angus Scale total score >3 with a baseline score ≤3. Treatment-emergent akathisia is defined as Barnes Akathisia Rating Scale global clinical assessment score >2 with a baseline score ≤2. Treatment-emergent dyskinesia is defined as any Abnormal Involuntary Movement Scale (AIMS) item 1-7 score ≥3 with a baseline score <3 for the item, or score ≥2 on two or more of AIMS items 1-7 with baseline <2 for the items. Study baseline is defined as last non-missing assessment prior to the first dose of study drug. Open-label baseline is defined as last non-missing assessment prior to the first dose of study drug in the open-label part.
Measured: At study baseline, open-label baseline, and up to study completion (up to approximately 18 weeks)
Change From Baseline in Body Weight
Study baseline is defined as last non-missing assessment prior to the first dose of study drug. Open-label baseline is defined as last non-missing assessment prior to the first dose of study drug in the open-label part.
Measured: At study baseline, Day 35 DB, open-label baseline, Day 84 OL, and end of study visit (up to approximately 18 weeks)
Change From Baseline in Body Mass Index (BMI)
Study baseline is defined as last non-missing assessment prior to the first dose of study drug. Open-label baseline is defined as last non-missing assessment prior to the first dose of study drug in the open-label part.
Measured: At study baseline, Day 35 DB, open-label baseline, Day 84 OL, and end of study visit (up to approximately 18 weeks)
Change From Baseline in Waist Circumference
Study baseline is defined as last non-missing assessment prior to the first dose of study drug. Open-label baseline is defined as last non-missing assessment prior to the first dose of study drug in the open-label part.
Measured: At study baseline, Day 35 DB, open-label baseline, Day 84 OL, and end of study visit (up to approximately 18 months)
Area Under the Concentration-Time Curve (AUC0-12) of Xanomeline and Trospium - Double-Blind Period
AUC₀-12 (Area Under the Concentration-Time Curve from time zero to 12 hours) is the total amount of drug in the blood measured from the time the drug is given (time zero) up to 12 hours after dosing.
Measured: On Day 28 of the Double-Blind Period
Maximum Observed Plasma Concentration (Cmax) of Xanomeline and Trospium - Double-Blind Period
Cmax is the highest concentration of a drug measured in the blood after it is given.
Measured: On Day 28 of the Double-Blind Period
Time to Cmax (Tmax) of Xanomeline and Trospium - Double-Blind Period
Tmax is the amount of time it takes to reach that highest concentration (Cmax) after the drug is given.
Measured: On Day 28 of the Double-Blind Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start29 May 2023
- Primary completion16 Sep 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zai Lab (Shanghai) Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919823
- Sponsor's protocol ID
- CN012-0063
- Other IDs
- ZL-2701-001
- Acronym
- UNITE-001
- Status last verified
- Dec 2025
- First submitted
- 16 Jun 2023
- Last updated
- 17 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Two-part Study With a 5-week Double-blind Part (Randomized, Parallel-group, Placebo-controlled) Followed by a 12-week Open-label Extension Part, to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects With DSM-5 Schizophrenia
- ClinicalTrials.gov ID
- NCT05919823
- Acronym / sponsor ID
- UNITE-001 / CN012-0063
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb companyIndustry (pharma, biotech, devices)
- Collaborators
- Zai Lab (Shanghai) Co., Ltd.
- Study start
- 29 May 2023 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Posted 21 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 3, Multicenter, Two-part Study with a 5-week Double-blind Part (Randomized, Parallel-group, Placebo-controlled) followed by a 12-week Open-label Extension Part, to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects with DSM-5 Schizophrenia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KarXT | Experimental | Drug: Xanomeline and Trospium Chloride Capsules |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Subject is Chinese national, aged 18 to 65 years, inclusive, at screening.
- Subject is capable of providing written informed consent.
- Subject has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 and MINI.
- Subject is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening.
- PANSS total score between 80 and 120,inclusive, with a scores of ≥4 (moderate or greater) for ≥2 of the following Positive Scale (P) items:
Key exclusion criteria (18 listed)
- Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using MINI version 7.0.2 at screening).
- Subjects who are newly diagnosed or are experiencing their first treated episode of schizophrenia.
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
- Subjects with human immunodeficiency virus (HIV), cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or liver function test results.
- History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xanomeline and Trospium Chloride CapsulesAlso: KarXTOral xanomeline 50 mg/trospium 20 mg BID on days 1-2 followed by xanomeline 100 mg/trospium 20 mg BID on days 3-7. The dose is increased to xanomeline 125 mg/trospium 30 mg BID on days 8-35 unless the subject is experiencing adverse events from the xanomeline 100 mg/ trospium 20 mg dose. Subjects who were increased to xanomeline 125 mg/trospium 30 mg will have the option to return to xanomeline 100 mg/ trospium 20 mg depending on clinical response and tolerability. | Drug | KarXT |
| PlaceboPlacebo Capsules | Drug | Placebo |
Primary outcome
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Week 5 of the Double-Blind Period
Time frame: At Baseline and at Week 5 of the Double-Blind Period
PANSS Total Score is a clinical tool used to measure the severity of symptoms in individuals with schizophrenia. It includes 30 items divided into three subscales: Positive Symptoms (e.g., hallucinations, delusions) Negative Symptoms (e.g., social withdrawal, lack of motivation) General Psychopathology (e.g., anxiety, depression) Each item is rated from 1 (absent) to 7 (extreme), resulting in a total score range from 30 to 210. Higher PANSS Total Scores indicate more severe symptoms and worse clinical outcomes. Baseline is defined as last non-missing assessment prior to the first dose of study drug.
24 secondary outcomes
Change From Baseline in Positive Symptom Score of the Positive and Negative Syndrome Scale (PANSS) at Week 5 of the Double-Blind Period
Time frame: At Baseline and at Week 5 of the Double-Blind Period
Change From Baseline in Negative Symptom Score of the Positive and Negative Syndrome Scale (PANSS) at Week 5 of the Double-Blind Period
Time frame: At Baseline and at Week 5 of the Double-Blind Period
Change From Baseline in Negative Marder Factor Score of the Positive and Negative Syndrome Scale (PANSS) at Week 5 of the Double-Blind Period
Time frame: At Baseline and at Week 5 of the Double-Blind Period
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score at Week 5 of the Double-Blind Period
Time frame: At Baseline and at Week 5 of the Double-Blind Period
Percentage of PANSS Responders (≥30% Change in PANSS Total Score From Baseline) at Week 5 of the Double-Blind Period
Time frame: At Baseline and at Week 5 of the Double-Blind Period
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Week 12 of the Open-Label Period
Time frame: At Baseline and at Week 12 of the Open-Label Period
Change From Baseline in Positive Symptom Score of the Positive and Negative Syndrome Scale (PANSS) at Week 12 of the Open-Label Period
Time frame: At Baseline and at Week 12 of the Open-Label Period
Change From Baseline in Negative Symptom Score of the Positive and Negative Syndrome Scale (PANSS) at Week 12 of the Open-Label Period
Time frame: At Baseline and at Week 12 of the Open-Label Period
Change From Baseline in Negative Marder Factor Score of the Positive and Negative Syndrome Scale (PANSS) at Week 12 of the Open-Label Period
Time frame: At Baseline and at Week 12 of the Open-Label Period
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score at Week 12 of the Open-Label Period
Time frame: At Baseline and at Week 12 of the Open-Label Period
Percentage of PANSS Responders (≥30% Change in PANSS Total Score From Baseline) at Week 12 of the Open-Label Period
Time frame: At Baseline and at Week 12 of the Open-Label Period
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Study Drug Withdrawal
Time frame: From first dose until study completion (up to approximately 18 weeks)
Number of Participants With Orthostatic Vital Sign Events
Time frame: From first dose until study completion (up to approximately 18 weeks)
Number of Participants With Elevated Liver Function Test Results
Time frame: At study baseline, Day 21 DB, Day 35 DB, open-label baseline, Day 14 OL, Day 84 OL, and end of study visit (up to approximately 18 weeks)
Number of Participants With Elevated Metabolic Syndrome Parameters
Time frame: At study baseline, Day 21 DB, Day 35 DB, open-label baseline, Day 14 OL, Day 84 OL, and end of study visit (up to approximately 18 weeks)
Number of Participants With Abnormal Electrocardiogram (ECG) Results
Time frame: At study baseline and up to study completion (up to approximately 18 weeks)
Number of Participants With Suicidal Ideation as Defined by a Columbia-Suicide Severity Rating Scale (C-SSRS) Ideation Score of 1 or Greater
Time frame: From first dose to study completion (up to approximately 18 weeks)
Number of Participants With Clinically Meaningful Changes in Simpson-Angus Scale (SAS), Barnes Akathisia Rating Scale (BARS), and Abnormal Involuntary Movement Scale (AIMS) Results
Time frame: At study baseline, open-label baseline, and up to study completion (up to approximately 18 weeks)
Change From Baseline in Body Weight
Time frame: At study baseline, Day 35 DB, open-label baseline, Day 84 OL, and end of study visit (up to approximately 18 weeks)
Change From Baseline in Body Mass Index (BMI)
Time frame: At study baseline, Day 35 DB, open-label baseline, Day 84 OL, and end of study visit (up to approximately 18 weeks)
Change From Baseline in Waist Circumference
Time frame: At study baseline, Day 35 DB, open-label baseline, Day 84 OL, and end of study visit (up to approximately 18 months)
Area Under the Concentration-Time Curve (AUC0-12) of Xanomeline and Trospium - Double-Blind Period
Time frame: On Day 28 of the Double-Blind Period
Maximum Observed Plasma Concentration (Cmax) of Xanomeline and Trospium - Double-Blind Period
Time frame: On Day 28 of the Double-Blind Period
Time to Cmax (Tmax) of Xanomeline and Trospium - Double-Blind Period
Time frame: On Day 28 of the Double-Blind Period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xanomeline and Trospium Chloride Capsules in people with Schizophrenia, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 28 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Week 5 of the Double-Blind Period (time frame: At Baseline and at Week 5 of the Double-Blind Period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.