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

• ClinicalTrials.gov Identifier: NCT04092686
• Recruitment Status: Completed
• First Posted: September 17, 2019
• Last Update Posted: November 21, 2023
• Sponsor: Sumitomo Pharma America, Inc.
• Information provided by (Responsible Party): Sumitomo Pharma America, Inc.

Tracking Information

• First Submitted Date: September 13, 2019
• First Posted Date: September 17, 2019
• Last Update Posted Date: November 21, 2023
• Actual Study Start Date: September 30, 2019
• Actual Primary Completion Date: June 14, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 13, 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: Same as current

Current Secondary Outcome Measures (submitted: September 13, 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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Clinical Trial That Will 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 18 -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 60 locations world wide. The study will last up to nine (9) weeks.

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 (75 and 100 mg/day) versus placebo over a 6-week Treatment Period in acutely psychotic subjects with schizophrenia. This study is projected to randomize approximately 462 subjects to 3 treatment groups (SEP-363856 75 mg/day, SEP-363856 100 mg/day, or placebo) in a 1:1:1 ratio. 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 hypotheses 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:

A 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 75mg
  SEP-363856 75mg tablet dosed once daily
• Drug: SEP-363856 100mg
  SEP-363856 100mg tablet dosed once daily
• Drug: Placebo
  Placebo tablet dosed once daily

Study Arms

• Experimental: SEP-363856 75mg
  SEP-363856 75mg dosed once daily
  Intervention: Drug: SEP-363856 75mg
• Experimental: SEP-363856 100mg
  SEP-363856 100mg dosed once daily
  Intervention: Drug: SEP-363856 100mg
• Placebo Comparator: Placebo
  Placebo dosed once daily
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 17, 2023): 464
• Original Estimated Enrollment (submitted: September 13, 2019): 462
• Actual Study Completion Date: June 14, 2023
• Actual Primary Completion Date: June 14, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Male or female subject between 18 to 65 years of age (inclusive) at the time of consent.
2. Subject must give written informed consent and privacy authorization prior to participation in the study; adolescents must also provide informed assent.
3. Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screeing.
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 on 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 investigator.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bulgaria, Croatia, Latvia, Russian Federation, Serbia, Ukraine, United States
• Removed Location Countries: Germany, Italy

Administrative Information

• NCT Number: NCT04092686
• Other Study ID Numbers: 361-302; 2019-000697-37 ( 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; Sumitomo Pharma America, Inc.

• PRS Account: Sumitomo Pharma America, Inc.
• Verification Date: November 2023