SEP-363856 for Schizophrenia

No longer recruiting at 36 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new treatment called SEP-363856 (also known as Ulotaront) for individuals with schizophrenia who are transitioning from their current antipsychotic medication. The main goal is to determine if this medication is both effective and safe. The trial suits those who have completed another study with SEP-363856 and have not used other mental health medications during that time. Individuals with schizophrenia who meet these criteria might find this trial a valuable opportunity. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to the validation of a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that SEP-363856 is likely to be safe for humans?

Research shows that SEP-363856 is generally well-tolerated by people with schizophrenia. In earlier studies, even higher doses, such as 100 mg, improved symptoms without causing additional safety issues. Serious side effects were rare and not directly linked to the treatment. For example, some patients experienced suicidal thoughts and depression, but these were not considered directly related to the medication.

Overall, SEP-363856 has a good safety record. It has been tested in both men and women, with no significant additional risks identified. The treatment effectively balances safety and effectiveness, making it a promising option for those considering participation in this clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for schizophrenia?

Most treatments for schizophrenia, like antipsychotics, work by blocking dopamine receptors. But SEP-363856 works differently, targeting the trace amine-associated receptor 1 (TAAR1) and serotonin 1A receptor, offering a novel approach to managing symptoms. Researchers are excited about this treatment because it may provide relief without the common side effects associated with traditional antipsychotics, such as weight gain and motor issues. This distinct mechanism of action could make SEP-363856 a game-changer for those who haven't had success with current medications.

What evidence suggests that SEP-363856 might be an effective treatment for schizophrenia?

Research has shown that SEP-363856, also known as ulotaront, may help treat schizophrenia. In one study, patients taking SEP-363856 showed noticeable improvements in their symptoms. Higher doses, particularly around 100 mg, enhanced these benefits without additional safety concerns. In a long-term study, ulotaront continued to improve symptoms over time. These results suggest that SEP-363856 could be a helpful treatment for people with schizophrenia. ^{1 2 5 6 7}

Who Is on the Research Team?

CNS Medical Director

Principal Investigator

Sumitomo Pharma America, Inc.

Are You a Good Fit for This Trial?

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

Subject has completed the Treatment Period of Study SEP361-308

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

Exclusion Criteria

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

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Otsuka Pharmaceutical Development & Commercialization, Inc.

Lead Sponsor

Trials

271

Recruited

170,000+

John Kraus

Otsuka Pharmaceutical Development & Commercialization, Inc.

Chief Medical Officer since 2023

MD, PhD

Tarek Rabah

Otsuka Pharmaceutical Development & Commercialization, Inc.

Chief Executive Officer since 2022

BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8660889/

Safety & Effectiveness of Ulotaront in Schizophrenia Study Specifically, the results of this long-term study indicate that ulotaront treatment was associated with sustained improvement in psychotic ...

2. academic.oup.com academic.oup.com/ijnp/article/28/9/pyaf059/8228252

Trajectory of efficacy and safety across ulotaront dose levels in ... We found that higher doses—especially around 100 mg—can improve schizophrenia symptoms without increasing safety concerns. These findings are important because ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02969369

NCT02969369 | A Study to Evaluate the Efficacy, Safety ... A study to evaluate the safety and tolerability of SEP-363856 in subjects with Parkinson's Disease Psychosis. This study is accepting male and female ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37165101/

Ulotaront: review of preliminary evidence for the efficacy ... In the 4-week study, ulotaront was well-tolerated, with an incidence of adverse events (AEs) numerically lower compared to placebo (45.8% vs.

5. news.us.sumitomo-pharma.com news.us.sumitomo-pharma.com/2020-04-15-New-England-Journal-of-Medicine-Publishes-Pivotal-Results-Evaluating-Sunovions-SEP-363856-for-the-Treatment-of-Schizophrenia

New England Journal of Medicine Publishes Pivotal ... In this study, once-daily, flexible-dose (50-75 mg) treatment with SEP-363856 demonstrated a statistically significant and clinically meaningful ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01994473

NCT01994473 | Study Assessing the Safety, Tolerability, ... This is a study designed to evaluate the safety, tolerability, and PK of SEP-363856 and its metabolite SEP-363854 in male and female subjects with schizophrenia ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40795331/

Trajectory of Efficacy and Safety Across Ulotaront Dose ... Conclusion: Ulotaront 100 mg appears greatest efficacy with favorable safety for acute schizophrenia. However, effect sizes were small, and ...