SEP-363856 for Schizophrenia

Recruiting at 45 trial locations

Overseen By Otsuka Contact Center Otsuka Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Must be taking: Antipsychotics

Disqualifiers: Alcohol use, Substance use, Bipolar, others

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: 6 weeks

522 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the efficacy and safety of Ulotaront (SEP-363856) for individuals with severe schizophrenia symptoms. Participants will receive either the experimental drug at two different doses or a placebo (a pill with no active medicine). The trial seeks individuals who have experienced a sudden worsening of schizophrenia symptoms in the last two months, requiring hospitalization or similar care. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to the development of a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that SEP-363856, also known as ulotaront, is generally safe for use. Studies have found that even at higher doses, such as 100 mg, it can improve schizophrenia symptoms without additional safety concerns, indicating no increase in side effects at these doses.

Further research has demonstrated that ulotaront can lead to ongoing improvement in psychotic symptoms over time, suggesting its safety for long-term use. While some side effects may occur, they are not more common or severe than expected.

Overall, the evidence indicates that ulotaront is a safe option for treating schizophrenia, especially compared to other treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about SEP-363856 for schizophrenia because it works differently from standard treatments like antipsychotics, which often target dopamine receptors. Instead, SEP-363856 acts on the trace amine-associated receptor 1 (TAAR1) and serotonin receptors, offering a new mechanism of action. This unique approach could potentially lead to fewer side effects, such as weight gain and movement disorders, which are common with current treatments. Additionally, the two dosage options, 75 mg and 100 mg, provide flexibility in treatment, potentially allowing for better personalization to meet individual patient needs.

What evidence suggests that this trial's treatments could be effective for schizophrenia?

Studies have shown that SEP-363856, also known as ulotaront, can help treat schizophrenia. Research indicates that patients using SEP-363856 experience lasting improvements in their symptoms. A study published in the New England Journal of Medicine found that this treatment reduced the overall severity of the illness. In this trial, participants will receive either SEP-363856 at doses of 75 mg or 100 mg, or a placebo. Notably, higher doses, like 100 mg, have been linked to better symptom relief without additional safety risks. These findings suggest that SEP-363856 could be a promising option for people with schizophrenia. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with schizophrenia, who are experiencing a recent worsening of symptoms and have responded well to antipsychotic treatment in the past year. They must be hospitalized or require hospitalization due to acute symptoms but haven't been hospitalized for more than two weeks at screening time.

Inclusion Criteria

My mental health has recently worsened significantly.

I responded well to antipsychotic treatment in the past year.

My symptoms worsened in the last 2 months.

Exclusion Criteria

Participant has had a decrease of ≥ 20% on the PANSS total score between screening and baseline

Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia

Sexually active participants or persons of childbearing potential who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SEP-363856 or placebo for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• SEP-363856

Trial Overview The study tests SEP-363856 against a placebo in people with acute schizophrenia. It's a phase 3 trial, meaning it's advanced in testing the drug's effectiveness and safety. Participants will be randomly assigned to either the drug or placebo without knowing which one they receive.

How Is the Trial Designed?

Group I: SEP-363856 75 mg Experimental Treatment 1 Intervention

SEP-363856 75 mg/day

Group II: SEP-363856 100 mg Experimental Treatment 1 Intervention

SEP-363856 100 mg/day

Group III: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

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

Published Research Related to This Trial

In a study of 450 patients with schizophrenia receiving placebo injections, a 10%-15% reduction in the PANSS total score after the first week was found to be a strong predictor of long-term response at week 9, indicating that early improvements can help identify potential placebo responders.

Patients with better judgment and insight at baseline (lower PANSS G12 scores) were also more likely to show a placebo response, suggesting that certain demographic and clinical characteristics may influence the effectiveness of placebo treatments in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Placebo Improvement Is a Marker for Subsequent Placebo Response in Long-Acting Injectable Antipsychotic Trials for Schizophrenia: Combined Analysis of 4 RCTs. Kumagai, F., Suzuki, T., Fleischhacker, WW., et al.[2019]

Citations

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

Safety and effectiveness of ulotaront (SEP-363856) in ... Specifically, the results of this long-term study indicate that ulotaront treatment was associated with sustained improvement in psychotic ...

2. 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 ...

3. 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 ... Patients treated with SEP-363856 also showed improvement in the overall severity of illness as assessed by the Clinical Global Impression Scale ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1911772

A Non–D2-Receptor-Binding Drug for the Treatment of ... We performed a randomized, controlled trial to evaluate the efficacy and safety of SEP-363856 in adults with an acute exacerbation of ...

5. 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 ...

6. otsuka-us.com otsuka-us.com/news/sumitomo-pharma-and-otsuka-announce-topline-results-phase-3-diamond-1-and-diamond-2-clinical

Sumitomo Pharma and Otsuka Announce Topline Results ... Sumitomo Pharma and Otsuka Announce Topline Results from Phase 3 DIAMOND 1 and DIAMOND 2 Clinical Studies Evaluating Ulotaront in Schizophrenia.