A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia

Therapuetic Areas:Psychiatry / Psychology
Age Range:18 - 60
Start Date:September 18, 2018
End Date:November 5, 2019
Contact:Sharon Sawchak

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A Phase 2, Randomized, Double-blinded Study to Assess the Safety, Tolerability, and Efficacy of KarXT in Hospitalized Adults With DSM-5 Schizophrenia

This is a Phase 2, randomized, double-blinded, placebo-controlled, inpatient study to examine
the efficacy, safety, and tolerability profile of KarXT in adult subjects diagnosed with
DSM-5 schizophrenia who are in an acute exacerbation phase. The primary objective of the
study is to assess the efficacy of KarXT (a fixed combination of xanomeline and trospium
chloride) (xanomeline 125 mg/trospium 30 mg twice daily [BID]) versus placebo in reducing
Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a
Diagnostic and Statistical Manual‒Fifth Edition (DSM-5) diagnosis of schizophrenia. The
secondary objectives of the study are to assess overall safety and tolerability of KarXT in
adult inpatients with a DSM-5 diagnosis of schizophrenia.

Inclusion Criteria:

1. Subject is aged 18-60 years, inclusive, at screening

2. Subject has a primary diagnosis of schizophrenia established by a comprehensive
psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013)
criteria and confirmed by Mini International Neuropsychiatric Interview for
Schizophrenia and Psychotic Disorder Studies (MINI) version 7.0.2.

3. Subject is experiencing an acute exacerbation or relapse of symptoms, with onset less
than 2 months before screening

4. Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at

1. Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P)
items at screening:

2. Item 1 (P1; delusions)

3. Item 2 (P2; conceptual disorganization)

4. Item 3 (P3; hallucinatory behavior)

5. Item 6 (P6; suspiciousness/persecution)

5. There should not be a change (improvement) in PANSS total score between screening and
baseline of more than 20%

6. Subjects taking a depot antipsychotic could not have received a dose of medication for
at least 1 and a half injection cycles before baseline (eg, 3 or more weeks off for a
2-week cycle)

7. Subject is capable of providing informed consent

1. A signed ICF must be provided before any study assessments are performed

2. Subject must be fluent (oral and written) in English in order to consent

8. Subject must have CGI-S score of ≥ 4 at screening and baseline visits

9. Body mass index must be ≥ 18 and ≤ 40 kg/m2

10. Both females of child bearing potential and males with partners of child bearing
potential must be willing to use a double-barrier method of birth control (ie, any
double combination of male or female condom with spermicidal gel, diaphragm, sponge,
or cervical cap with spermicidal gel) during the study and for 7 days after the last
dose of study drug.

11. Subject has an identified reliable informant

Exclusion Criteria:

1. Any primary DSM-5 disorder other than schizophrenia within 12 months before screening
(confirmed using MINI version 7.0.2 at screening)

2. 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, to exclude patients with human immunodeficiency virus (HIV), cirrhosis,
biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral
infections based on the liver function test results.

3. History of or high risk of urinary retention, gastric retention, or narrow-angle

4. History of irritable bowel syndrome (with or without constipation) or serious
constipation requiring treatment within the last 6 months

5. Has a DSM-5 diagnosis of moderate to severe substance abuse disorder (except tobacco
use disorder) within the 12 months before screening (confirmed using MINI version
7.0.2 at screening), or current abuse as determined by urine toxicology screen or
alcohol test. A screening subject with mild substance abuse disorder within the 12
months before screening must be discussed and agreed upon with the medical monitor
before he/she can be allowed into the study.

6. Clinically significant abnormal finding on the physical examination, medical history,
ECG, or clinical laboratory results at screening

7. Pregnant, lactating, or less than 3 months postpartum. Sperm donation is not allowed
for 90 days after the final dose of study drug

8. If, 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
their ability to adhere to the protocol visit schedule or fulfill visit requirements

9. Subject has had psychiatric hospitalization(s) for more than 30 days (cumulative)
during the 90 days before screening

10. 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 required clozapine within the last 12 months

11. Risk of violent or destructive behavior

12. Current involuntary hospitalization or incarceration

13. Participation in another clinical study in which the subject received an experimental
or investigational drug agent within 3 months of screening
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