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Also known as bitopertin [RO4917838], RO4917838
bitopertin · 10 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | PLACEBO_COMPARATOR | - |
| RO4917838 20 milligrams (mg) | EXPERIMENTAL | Participants, on stable antipsychotics, will receive RO4917838 orally at 20 mg once daily (QD) up to 56 weeks followed by an optional treatment extension for up to 3 years. |
| RO4917838 10 mg | EXPERIMENTAL | Participants, on stable antipsychotics, will receive RO4917838 orally at 10 mg QD up to 56 weeks followed by an optional treatment extension for up to 3 years. |
| Placebo | PLACEBO_COMPARATOR | Participants, on stable antipsychotics, will receive RO4917838 matching placebo orally QD up to 56 weeks. |
| Bitopertin oral dose level 1 | EXPERIMENTAL | - |
| Bitopertin oral dose level 2 | EXPERIMENTAL | - |
| Bitopertin 10 mg + Antipsychotics | EXPERIMENTAL | Treatment Period 1: Participants will receive bitopertin 10 milligrams (mg) tablet orally once daily for 24 weeks. Treatment Period 2: Participants will receive bitopertin 10 mg tablet orally once daily for 28 weeks (up to Study Week 52). After Week 52 there will be a 4-week washout period for at least 50 percent (%) of participants (up to Week 56). Long-Term Extension: After Week 56, participants will enter the long term extension period and continue to receive bitopertin 10 mg tablet orally once daily up to 3 years. In addition, throughout the study, participants will continue their same stable antipsychotic treatment as they were receiving prior to entry in the study. |
| Bitopertin 20 mg + Antipsychotics | EXPERIMENTAL | Treatment Period 1: Participants will receive bitopertin 20 mg tablet orally once daily for 24 weeks. Treatment Period 2: Participants will receive bitopertin 20 mg tablet orally once daily for 28 weeks (up to Study Week 52). After Week 52 there will be a 4-week washout period for at least 50% of participants (up to Week 56). Long-Term Extension: After Week 56, participants will enter the long term extension period and continue to receive bitopertin 20 mg tablet orally once daily up to 3 years. In addition, throughout the study, participants will continue their same stable antipsychotic treatment as they were receiving prior to entry in the study. |
| Bitopertin | EXPERIMENTAL | Part 1 - The main study - 16 weeks in total: Participants will undergo a 6-week dose-escalation period followed by 10 weeks of treatment at the attained target dose of bitopertin. Part 2 - Open Label Extension (OLE) - up to an additional 12 months: Participants will be given the option to enroll into the OLE once the 16-week treatment of Part 1 has been completed. Participants who decide not to enroll in the OLE, at the end of Part 1 will enter a 6-week follow-up period. |
| Bitopertin 30 mg | EXPERIMENTAL | Participants in Stratum 1 will receive bitopertin 30 mg from Day 1 to Week 16 in addition to their background therapy with an SSRI. Participants in Stratum 2 will receive placebo from Day 1 and will then start bitopertin 30 mg at the Week 2 until Week 16 in addition to their background therapy with an SSRI. |
| Bitopertin 10 mg | EXPERIMENTAL | Participants in Stratum 1 will receive bitopertin 10 mg from Day 1 to Week 16 in addition to their background therapy with an SSRI. Participants in Stratum 2 will receive placebo from Day 1 and will then start bitopertin 10 mg at the Week 2 until Week 16 in addition to their background therapy with an SSRI. |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| C | ACTIVE_COMPARATOR | - |
| D | PLACEBO_COMPARATOR | - |
| 4 | PLACEBO_COMPARATOR | - |
| RO4917838 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Oral doses, once a day for 52 weeks |
| RO4917838 | DRUG | Oral dose level 1, once a day for 52 weeks |
| Antipshychotics (Standard of Care) | DRUG | Participants will continue to receive their stable antipshychotic as standard of care based on their prescription up to Week 56. |
| bitopertin [RO4917838] | DRUG | Oral dose level 1, once a day for 52 weeks |
| Bitopertin | DRUG | Participants will receive 10 mg or 20 mg of bitopertin. |
| Antipsychotics | DRUG | Participants will continue to receive their stable antipsychotic regiment throughout the study. Study protocol does not specify any particular antipsychotic drug and regimen. |
| SSRI | DRUG | Participants will continue their background SSRI treatment as per standard of care at the same dose taken during the 8 weeks prior to Day 1. Protocol does not enforce any particular SSRI drug or regimen. |
| olanzapine | DRUG | 15 mg orally daily, 4 weeks |
| Standard antipsychotic therapy | DRUG | As prescribed |
Inclusion Criteria: * Adult patients, \>/= 18 years of age * Diagnosis of schizophrenia * Clinical stability for 16 weeks (4 months) prior to randomization * Antipsychotic treatment stability for the past 12 weeks prior to randomization * With the exception of clozapine, patients are on any of the ...
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Bitopertin is an investigational small molecule developed by Roche Holding AG under the code RO4917838. It has been studied in clinical trials for beta-thalassemia, obsessive-compulsive disorder, and schizophrenia. It is not an approved medicine and remains in clinical development, with the most recent studies conducted in Phase 2.
Bitopertin targets SLC6A9, also known as the glycine transporter 1, and acts as an inhibitor of this target. By inhibiting SLC6A9, bitopertin modulates glycine availability in the central nervous system, which is the mechanism explored across its schizophrenia and obsessive-compulsive disorder programs.
Bitopertin is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche conducted the clinical development program for the drug, including Phase 2 and Phase 3 studies in schizophrenia, a Phase 2 study in obsessive-compulsive disorder, and a Phase 2 study in beta-thalassemia.
Bitopertin is in Phase 2 development overall. Its clinical program includes Phase 2 trials in beta-thalassemia and obsessive-compulsive disorder, along with completed Phase 2 and Phase 3 studies in schizophrenia. The drug is investigational and has not been approved for any indication.
Bitopertin has been evaluated in four completed trials. These include NCT03271541 in non-transfusion-dependent beta-thalassemia, NCT01674361 in obsessive-compulsive disorder with SSRIs, NCT01235585 in sub-optimally controlled schizophrenia, and NCT01234779 in acute exacerbation of schizophrenia. Total enrollment across these studies was 2,147 participants.
Yes, bitopertin and RO4917838 refer to the same compound. RO4917838 is Roche's internal development code for bitopertin, and it appears in the titles of the clinical trials, including the beta-thalassemia, obsessive-compulsive disorder, and schizophrenia studies listed on ClinicalTrials.gov.