A Clinical Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic People With Schizophrenia, Followed by an Open-label Extension Phase

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sumitomo Pharma Co. Ltd.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

completed 15 Feb 2024

Decision date (initial)

2023-08-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sumitomo Pharma Co. Ltd.

External identifiers

EU CT number

2022-503006-20-00

ClinicalTrials.gov

NCT04825860

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacogenetic, Pharmacogenomic, Efficacy, Safety, Pharmacokinetic

To evaluate the efficacy of fixed doses of SEP-363856 (50 and 75 mg/day) compared with placebo in acutely psychotic patients with schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) total score.

Secondary objectives 1

1. To evaluate the efficacy of fixed doses of SEP-363856 (50 and 75 mg/day) compared with placebo in acutely psychotic patients with schizophrenia as measured by the Clinical Global Impression-Severity (CGI-S) score.

Conditions and MedDRA coding

Acutely Psychotic Patients with Schizophrenia

Regulatory references

Scientific advice from competent authorities

Pharmaceuticals And Medical Devices Agency

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Inclusion criteria for the double-blind phase: Must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study-related activities. If the subject is considered a minor according to local regulations at the time of collection of the informed consent, written consent will be obtained from a legally acceptable representative (guardian) in addition to that obtained from the subject.
2. Male or female between 18 to 65 years of age (inclusive) at the time of consent.
3. Must meet DSM-5 criteria for schizophrenia as established by clinical interview at Screening (using the DSM-5 as a reference and confirmed using the Structured Clinical Interview for DSM-5-Clinical Trials Version [SCID-5-CT]).
4. Must have a CGI-S score ≥ 4 (moderately ill) at Screening and Baseline.
5. Must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 (moderate) on 2 or more of the following PANSS items: delusions (P1), conceptual disorganization (P2), hallucinations (P3), and unusual thought content (G9) at Screening and Baseline.
6. Must have an acute exacerbation of psychotic symptoms (no longer than 2 months prior to providing informed consent for this study). The acute exacerbation should include: - Marked deterioration of functioning in one or more areas, such as occupational, social, or personal care or hygiene. - In the case that the subject has been hospitalized for the purpose of treating an acute psychotic exacerbation at the timing of Screening, the duration must be no more than 2 consecutive weeks immediately before Screening.
7. Subjects with more than 3 prior lifetime inpatient hospitalization for the treatment of an acute exacerbation of schizophrenia may be eligible only after approval with the Medical Monitor.
8. Inclusion criteria for the open-label phase: 1. Must have completed the 6-week study treatment and all scheduled assessments at Visit 9 in the double-blind phase. 2. Female subjects of childbearing potential must have a negative urine pregnancy test at Visit 9. 3. Female subjects of childbearing potential must agree to use highly effective and reliable contraception throughout the study and for at least 30 days after the last dose of study drug has been taken. In the Investigator’s judgment, the subject will adhere to this requirement. 4. Male subjects must agree to avoid fathering a child and use highly effective methods of birth control from Screening until at least 30 days after the last study drug administration.

Exclusion criteria 10

1. Exclusion criteria for the double-blind phase: Have a decrease (improvement of symptoms) of ≥ 20% on the PANSS total score between Screening and Baseline.
2. Have 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, 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 have not been a focus of primary treatment.
3. Judged to be resistant to antipsychotic treatment by the Investigator, based on failure to respond to 2 or more marketed antipsychotic agents within a 1-year period prior to Screening, given at adequate dose as per labeling, for at least 4 weeks (28 consecutive days).
4. Answer “yes” to “Suicidal Ideation” Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at Screening (ie, in the past month [30 days]) or at Baseline (ie, since last visit).
5. At significant risk of harming self, others, or objects based on Investigator’s judgment.
6. Have attempted suicide within 6 months prior to Screening.
7. Subject is involuntarily hospitalized.
8. Have received a total dose of antipsychotic medication equivalent to ≥ 12.0 mg/day of haloperidol for the majority of current episode (acute exacerbation). If receiving antipsychotic medication equivalent to ≥ 12.0 mg/day of haloperidol has been for less than 2 weeks, and the reason for the high dose was to temporarily control the subject due to acute agitation or similar need to manage the subject, the subject may be eligible after consultation with the Medical Monitor.
9. Have 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.
10. Exclusion criteria for the open-label phase: 1. Answer “yes” to “Suicidal Ideation” Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at Visit 9. 2. Have a clinically significant abnormality including PE, vital signs, ECG, or laboratory test at Visit 9 that the Investigator in consultation with the Medical Monitor considers to be inappropriate to allow participation in the study. 3. In the opinion of the Investigator, subjects who are unsuitable in any other way to participate in this study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Primary Efficacy Endpoint: Change from Baseline in PANSS total score at Week 6

Secondary endpoints 1

1. Efficacy Endpoint: Secondary Efficacy Endpoint: Change from Baseline in CGI-S score at Week 6

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sumitomo Pharma Co. Ltd.

Sponsor organisation

Sumitomo Pharma Co. Ltd.

Address

6-8 Doshomachi 2 Chome, Chuo Ku Chuo Ku

City

Osaka

Postcode

541-0045

Country

Japan

Scientific contact point

Organisation

Sumitomo Pharma Co. Ltd.

Contact name

Clinical trial information desk

Public contact point

Organisation

Sumitomo Pharma Co. Ltd.

Contact name

Product information center

Third parties 8

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications