E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment-resistant schizophrenia |
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E.1.1.1 | Medical condition in easily understood language |
Treatment-resistant schizophrenia |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10072913 |
E.1.2 | Term | Treatment-resistant schizophrenia |
E.1.2 | System Organ Class | 100000004873 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety and tolerability of the long-term treatment with Lu AF35700 |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
For 16159A-patients
• The patient has completed Study 16159A.
• The patient is able to read and understand the Informed Consent Form.
• The patient has signed the Informed Consent Form specific for Study 16159B.
• The patient can potentially benefit from 52-week treatment with Lu AF35700 according to the investigator’s clinical judgement.
For 16323A-patients
• The patient has completed the dosing period of Study 16323A.
• The patient is able to read and understand the Informed Consent Form.
• The patient has signed the Informed Consent Form specific Study 16159B.
• The patient has a confirmed diagnosis of schizophrenia according to DSM-5™.
• The patient can potentially benefit from 52-week treatment with Lu AF35700 according to the investigator’s clinical judgement.
For Other Patients
• The patient has schizophrenia, diagnosed according to DSM-5™.
• The patient is a man or woman, aged ≥18 years.
• The patient has been prescribed oral antipsychotic treatment at the recommended dose range as stated in the summary of product characteristics or equivalent label for 6 weeks prior to the Screening Visit.
• The patient has a PANSS total score ≥60 and ≤90 at Screening and Baseline Visits.
• The patient has a Clinical Global Impression – Severity of Illness (CGI-S) score ≤4.
• The patient is in need of a change in the current antipsychotic treatment and, according to the investigator’s clinical judgement, the patient can potentially benefit from a switch to another treatment including, but not limited to, any of the following reasons:
- lack of adequate response to his or her current antipsychotic medication;
- poor tolerability to his or her current antipsychotic medication;
- unwillingness of the patient to adhere to his or her current antipsychotic medication. |
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E.4 | Principal exclusion criteria |
For 16159A-patients
• The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 16159A.
• The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers “Yes” to any question on the Suicidal Behaviour section of the C-SSRS, OR Answers “Yes” to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS
For 16323A-patients
• The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 16323A.
• The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers “Yes” to any question on the Suicidal Behaviour section of the C-SSRS, OR Answers “Yes” to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS
For Other Patients
• The patient has any current psychiatric disorder (DSM-5™ criteria) other than schizophrenia established as the primary diagnosis.
• The patient is experiencing acute exacerbation of psychotic symptoms at the Screening Visit, between the Screening and Baseline Visits or at the Baseline Visit.
• The patient is treated with clozapine at the time of the Screening Visit.
• The patient has a substance use disorder (except nicotine) which according to the investigator’s judgment may compromise the patient’s ability to comply with the study procedures, or preclude the benefits of the study medication.
• The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers “Yes” to any question on the Suicidal Behaviour section of the C-SSRS, OR Answers “Yes” to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety and tolerability
Based on the Safety variables (Adverse events, clinical safety laboratory tests, vital signs, weight, waist circumference and ECG |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From dosing to end of study (57 weeks) |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 49 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Bulgaria |
Canada |
Czech Republic |
Estonia |
Finland |
Italy |
Mexico |
Poland |
Romania |
Russian Federation |
Serbia |
Slovakia |
Spain |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The last protocol-specified contact with the last patient ongoing in the study |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |