A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

• ClinicalTrials.gov Identifier: NCT04072354
• Recruitment Status: Completed
• First Posted: August 28, 2019
• Last Update Posted: May 8, 2024
• Sponsor: Sumitomo Pharma America, Inc.
• Information provided by (Responsible Party): Sumitomo Pharma America, Inc.

Tracking Information

• First Submitted Date: August 26, 2019
• First Posted Date: August 28, 2019
• Last Update Posted Date: May 8, 2024
• Actual Study Start Date: September 11, 2019
• Actual Primary Completion Date: May 12, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 28, 2019)

Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Endpoint (Week 6) [ Time Frame: Baseline and Week 6 ]

PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210.

Original Primary Outcome Measures (submitted: August 26, 2019)

Change from Baseline in PANSS total score at Endpoint (Week 6) [ Time Frame: Baseline and Week 6 ]

Change from Baseline in PANSS total score at Endpoint in Adults (Week 6)

Current Secondary Outcome Measures (submitted: August 28, 2019)

Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Endpoint (Week 6) [ Time Frame: Baseline and Week 6 ]

The CGI-S is a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity.

Original Secondary Outcome Measures (submitted: August 26, 2019)

Change from Baseline in CGI-S score at Endpoint (Week 6) [ Time Frame: Baseline and Week 6 ]

Change from Baseline in CGI-S score at Endpoint in Adults (Week 6)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
• Official Title: A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Subjects With Schizophrenia
• Brief Summary: A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 13 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 70 locations worldwide. The study will last up to 9 weeks total time.

Detailed Description

This is a multicenter, randomized, double-blind, parallel-group, fixed-dosed study evaluating the efficacy and safety of two doses of SEP-363856 (50 and 75 mg/day) versus placebo over a 6-week Treatment Period in acutely psychotic subjects with schizophrenia. This study is projected to randomize approximately 435 subjects (18-65 years) to 3 treatment groups (SEP-363856 50 mg/day, SEP-363856 75 mg/day, or placebo) in a 1:1:1 ratio. In addition, the study will randomize approximately 90 adolescent subjects (13-17 years) in a 1:1:1 ratio to the 3 treatment groups (with approximately 30 subjects per group) in a separate cohort. Treatment assignment will be stratified by country. Study drug will be taken once a day and may be taken with or without food.

This study is designed to test the hypothesis that, treatment with SEP-363856 in adult subjects with schizophrenia will result in significantly greater reduction (i.e. improvement) in PANSS total score and CGI-S score at Week 6 from Baseline when compared to placebo. The overall Type I error is controlled for two hierarchical families of hypotheses. The first family includes hypotheses about the testing of change from Baseline in PANSS total score at Week 6 between each of the SEP-363856 dose levels vs. placebo. The second family of hypotheses are about the testing of change from Baseline in CGI-S score at Week 6 between each of the SEP-363856 dose levels vs. placebo.

• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

randomized, double-blind, parallel-group, placebo controlled, fixed-dose multicenter study

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

double-blind

Primary Purpose: Treatment

• Condition: Schizophrenia

Intervention

• Drug: SEP-363856 50mg
  SEP-363856 50mg tablet dosed once daily
• Drug: SEP-363856 75mg
  SEP-363856 75mg tablet dosed once daily
• Drug: Placebo
  Placebo tablet dosed once daily

Study Arms

• Experimental: SEP-363856 50mg
  SEP-363856 50mg dosed once daily
  Intervention: Drug: SEP-363856 50mg
• Experimental: SEP-363856 75mg
  SEP-363856 75mg dosed once daily
  Intervention: Drug: SEP-363856 75mg
• Placebo Comparator: Placebo
  Placebo dosed once daily
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 16, 2023): 463
• Original Estimated Enrollment (submitted: August 26, 2019): 525
• Actual Study Completion Date: September 12, 2023
• Actual Primary Completion Date: May 12, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Male or female subject between 13 to 65 years of age (inclusive) at the time of consent.
2. Subject or subjects parent/legal guardian [adolescents] must give written informed consent and privacy authorization prior to participate in the study; adolescents must also provide informed assent..
3. Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screening
4. Subject must have a CGI-S score ≥ 4
5. Subject must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, and unusual thought content
6. Subject has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent).
7. Subject has marked deterioration of functioning in one or more areas.
8. Subject is, in the opinion of the Investigator, generally healthy based on screening medical history, PE, neurological examination, vital signs, ECG, and clinical laboratory values.

Exclusion Criteria:

1. Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months or lifetime history of significant substance abuse that in the opinion of the Investigator or Sponsor, may have had a significant and potentially permanent impact of the brain or other body systems, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment.
2. Subject is at significant risk of harming self, others, or objects based on Investigator's judgment.
3. Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study:
4. Female subject who is pregnant or lactating
5. Subject has any clinically significant abnormal laboratory value(s) at Screening as determined by the investigator.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 13 Years to 65 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bulgaria, Colombia, Russian Federation, Serbia, Ukraine, United States

Administrative Information

• NCT Number: NCT04072354
• Other Study ID Numbers: SEP361-301; 2019-000470-36 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: IPD for this study may be made available upon request via the Vivli Global Center for Clinical Research Data site.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: IPD will be made available upon request within 12 months of posting the study results on ct.gov.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• URL: http://vivli.org

• Current Responsible Party: Sumitomo Pharma America, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Sumitomo Pharma America, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: CNS Medical Director; Sunovion Pharmaceuticals In.

• PRS Account: Sumitomo Pharma America, Inc.
• Verification Date: May 2024