SEP-363856 for Schizophrenia

No longer recruiting at 81 trial locations

Overseen By CNS Medical Director

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sunovion

Disqualifiers: Alcohol use disorder, Substance use disorder, Major depressive disorder, Bipolar disorder, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, SEP-363856, to determine its safety and effectiveness for individuals experiencing acute psychotic episodes due to schizophrenia. Participants will receive either the investigational drug or a placebo (a harmless pill with no active ingredients) to compare results. The trial seeks to find better treatments for those facing a sudden worsening of psychotic symptoms, such as hallucinations or delusions. It is suitable for individuals diagnosed with schizophrenia who have experienced significant symptom worsening in the past two months. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study 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 well-tolerated by people with schizophrenia. In one study, patients took the drug for six months and reported only mild side effects, such as slight dizziness and headaches. Another study found that both 75 mg and 100 mg doses were safe. Specifically, patients taking 100 mg experienced good results with manageable side effects.

Overall, studies suggest that SEP-363856 could be a safe option for treating schizophrenia, with most side effects being mild and temporary. ^{1 2 3 4 5}

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

Researchers are excited about SEP-363856 because it offers a fresh approach for treating schizophrenia. Unlike traditional antipsychotics that often target dopamine receptors, SEP-363856 works differently by targeting the trace amine-associated receptor 1 (TAAR1) and serotonin receptors. This novel mechanism could potentially reduce common side effects associated with standard treatments like weight gain and movement disorders. Plus, with options for both 75mg and 100mg doses, there's flexibility in tailoring the treatment to individual needs.

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

Research has shown that SEP-363856, which participants in this trial may receive, can help improve symptoms in people with schizophrenia. In one study, patients who took SEP-363856 showed significant improvement in their overall condition, as measured by tests like the PANSS, commonly used to assess schizophrenia symptoms. Another study found that higher doses, especially 100 mg, reduced symptoms without causing additional safety issues. Long-term studies found that SEP-363856 led to lasting improvement in symptoms. Overall, these findings suggest that SEP-363856 could be a promising treatment for schizophrenia. ^{2 5 6 7 8}

Who Is on the Research Team?

CNS Medical Director

Principal Investigator

Sumitomo Pharma America, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject must give written informed consent and privacy authorization prior to participation in the study; adolescents must also provide informed assent.

Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screeing.

You are experiencing significant decline in one or more areas of your daily functioning.

Exclusion Criteria

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

Subject is at significant risk of harming self, others, or objects based on Investigator's judgment

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

Treatment

Participants receive either SEP-363856 (75 mg or 100 mg) or placebo once daily for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• SEP-363856

How Is the Trial Designed?

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

SEP-363856 75mg dosed once daily

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

SEP-363856 100mg dosed once daily

Group III: Placebo Placebo Group 1 Intervention

Placebo dosed once daily

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

Published Research Related to This Trial

The mouthrinse containing 0.05% CHX and 0.05% CPC significantly reduced plaque levels in patients with poor oral hygiene over a 3-month period, indicating its efficacy in improving oral health (P<0.001).

While the mouthrinse effectively decreased plaque and bleeding on probing, it did not show a significant impact on gingival inflammation or overall patient-reported outcomes, suggesting that while it helps with plaque control, it may not fully address all aspects of gum health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower concentration of chlorhexidine and cetyl-pyridinium chloride mouthwash demonstrates some efficacy. Lamont, T.[2012]

The C1-C2 self-sustained natural apophyseal glide (SNAG) technique significantly improved the range of motion in the cervical spine by 15 degrees in participants with cervicogenic headaches, compared to only 5 degrees in the placebo group, indicating its effectiveness in addressing C1-C2 dysfunction.

Participants using the C1-C2 self-SNAG reported a substantial reduction in headache symptoms, with scores decreasing by 54% over 12 months, demonstrating its long-term efficacy in managing cervicogenic headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a C1-C2 self-sustained natural apophyseal glide (SNAG) in the management of cervicogenic headache. Hall, T., Chan, HT., Christensen, L., et al.[2022]

In a study involving six competitive wheelchair athletes, short-term oral creatine supplementation did not significantly improve 800 m performance compared to a placebo, indicating that creatine may not enhance performance in this specific group.

All measured parameters, including completion time, perceived exertion, lactate levels, and heart rate, showed no significant differences between the creatine and placebo conditions, suggesting that creatine supplementation may not be effective for trained, spinal cord-injured athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of creatine supplementation on 800 m wheelchair performance: a pilot study. Perret, C., Mueller, G., Knecht, H.[2013]

In a study involving 10 volunteers with spinal cord injury, abdominal neuromuscular electrical stimulation (NMES) improved colonic transit in most segments but negatively impacted lung capacity, specifically forced vital capacity (FVC).

Participants in the NMES group reported higher satisfaction regarding the aesthetic effects on their abdominal wall compared to the placebo group, suggesting potential cosmetic benefits alongside functional improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation of completely paralyzed abdominal muscles in spinal cord-injured patients: a pilot study. Hascakova-Bartova, R., Dinant, JF., Parent, A., et al.[2011]

In a clinical trial with 73 participants suffering from rotator cuff related shoulder pain, omega-3 polyunsaturated fatty acids (PUFAs) showed a modest improvement in pain and disability outcomes, particularly noted in the Shoulder Pain and Disability Index (SPADI) at 3 months.

However, there was no significant difference in the primary outcome, the Oxford Shoulder Score (OSS), between the omega-3 group and the placebo group at the 2-month mark, indicating that while there may be some benefits, they are not robust.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of long-chain omega-3 polyunsaturated fatty acids in the management of rotator cuff related shoulder pain. Sandford, FM., Sanders, TA., Wilson, H., et al.[2022]

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. 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 ...

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

A Non–D2-Receptor-Binding Drug for the Treatment of ... The mean total score on the PANSS at baseline was 101.4 in the SEP-363856 group and 99.7 in the placebo group, and the mean change at week 4 was ...

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

6. nature.com nature.com/articles/s41537-021-00190-z

Safety and effectiveness of ulotaront (SEP-363856) in ... Safety and effectiveness of ulotaront (SEP-363856) in schizophrenia: results of a 6-month, open-label extension study. Christoph U. Correll ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10465394/

Ulotaront: review of preliminary evidence for the efficacy ... Ulotaront: preliminary safety and tolerability data. A preliminary ... Safety and effectiveness of ulotaront (SEP-363856) in ...

8. guidetopharmacology.org guidetopharmacology.org/GRAC/LigandDisplayForward?tab=clinical&ligandId=10454

ulotaront | Ligand page SEP-363856 is being developed by Sunovion Pharmaceuticals and PsychoGenics, and was granted FDA Breakthrough Therapy Designation as an anti-schizophrenia ...