SEP-363856 for Schizophrenia

Recruiting at 20 trial locations

Overseen By CNS Medical Director

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sunovion

Must be taking: Antipsychotics

Disqualifiers: Suicidal, Abnormal ECG, Drug use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

67 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new schizophrenia medication called SEP-363856 in people who have already started using it. The goal is to see if it is safe and effective over several months. The medication works by affecting brain chemicals to help reduce symptoms of schizophrenia.

Do I have to stop taking my current medications for the trial?

The trial involves switching from your current antipsychotic medication to SEP-363856. It does not specify if you need to stop other medications, so it's best to discuss this with the trial team.

What data supports the effectiveness of the drug SEP-363856 (Ulotaront) for treating schizophrenia?

Ulotaront has shown promise in reducing both positive and negative symptoms of schizophrenia in Phase 2 clinical studies, without causing the common side effects seen with other antipsychotics. It has been granted Breakthrough Therapy Designation by the FDA, indicating its potential as a novel treatment for schizophrenia. ^{1 2 3 4 5}

Is ulotaront (SEP-363856) safe for humans?

Ulotaront (SEP-363856) has been studied in humans for schizophrenia and appears to be generally safe, with minimal changes in body weight, cholesterol, triglycerides, and no movement disorders observed over a 26-week period. It also showed no significant adverse effects on prolactin levels, which is a hormone that can affect mood and behavior. ^{2 4 5 6 7}

How is the drug SEP-363856 (Ulotaront) different from other schizophrenia treatments?

SEP-363856 (Ulotaront) is unique because it works by activating trace amine-associated receptor 1 and serotonin 5-HT1A receptors, unlike other antipsychotics that block dopamine D2 receptors. This novel mechanism may reduce symptoms of schizophrenia without causing the common side effects associated with traditional antipsychotics. ^{1 2 4 5 8}

Research Team

CNS Medical Director

Principal Investigator

Sumitomo Pharma America, Inc.

Eligibility Criteria

This trial is for men and women with schizophrenia who have finished the SEP361-308 study. They must not have used any psychotropic drugs other than their previous antipsychotic, allowed medications during that study, and women need a negative pregnancy test at the end of it. People can't join if they're pregnant, breastfeeding, suicidal, or show significant health issues in physical exams or drug tests at the end of SEP361-308.

Inclusion Criteria

Subject has given written informed consent and privacy authorization prior to participation in the study

I haven't taken any psychotropic drugs other than those allowed in the study.

Subject has completed the Treatment Period of Study SEP361-308

Exclusion Criteria

Subject is suicidal based on the Columbia - Suicide Severity Rating Scale (C-SSRS) assessment at the End of Treatment (EOT) Visit of Study SEP361-308

Subject has a positive rapid urine drug screen at the EOT Visit of Study SEP361-308

I had a significant health issue found in my last study visit.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SEP-363856 (50 to 100 mg/day) for the treatment of schizophrenia

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SEP-363856

Trial Overview The trial continues to assess SEP-363856's effectiveness and safety for schizophrenia patients switching from their current medication to this new one. It will take place across roughly 24 sites in North America over about 25 weeks.

Participant Groups

Group I: SEP-363856 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Sunovion

Lead Sponsor

Trials

190

Recruited

48,900+

Dr. Armin Szegedi

Sunovion

Chief Medical Officer since 2023

MD from Semmelweis University

Dr. Antony Loebel

Sunovion

Chief Executive Officer since 2019

MD from Washington University School of Medicine

Sumitomo Pharma America, Inc.

Lead Sponsor

Trials

244

Recruited

51,500+

Jatin Shah

Sumitomo Pharma America, Inc.

Chief Medical Officer since 2024

MD from an unspecified institution

Tsutomu Nakagawa

Sumitomo Pharma America, Inc.

Chief Executive Officer since 2024

MBA from Waseda University

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Unlocking the Therapeutic Potential of Ulotaront as a Trace Amine-Associated Receptor 1 Agonist for Neuropsychiatric Disorders. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

In Vitro ADME and Preclinical Pharmacokinetics of Ulotaront, a TAAR1/5-HT1A Receptor Agonist for the Treatment of Schizophrenia. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Ulotaront: review of preliminary evidence for the efficacy and safety of a TAAR1 agonist in schizophrenia. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Phase I, Open-Label, Fixed Sequence Study to Investigate the Effect of Cytochrome P450 2D6 Inhibition on the Pharmacokinetics of Ulotaront in Healthy Subjects. [2023]

5. England pubmed.ncbi.nlm.nih.gov

A sensitive LC-MS/MS method for simultaneous quantification of ulotaront and its N-desmethyl metabolite in human plasma and application to a clinical study. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Population pharmacokinetic analysis of ulotaront in subjects with schizophrenia. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of ulotaront (SEP-363856) in schizophrenia: results of a 6-month, open-label extension study. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Ulotaront, a Trace Amine-Associated Receptor 1/Serotonin 5-HT1A Agonist, in Patients With Parkinson Disease Psychosis: A Pilot Study. [2023]