Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia

Study Overview
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Brief Summary
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To evaluate the safety and tolerability of the long-term treatment with Lu AF35700.

Detailed Description
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Safety study in patients with schizophrenia who have participated and completed a study investigating Lu AF35700 including Studies 16159A and 16323A. Or in patients with schizophrenia for whom a switch of antipsychotic treatment can be potentially beneficial according to the investigator's clinical judgement.

Official Title
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Interventional, Open-label, Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Lu AF35700


Participation Criteria
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Eligibility Criteria
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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. 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 Columbia-Suicide Severity Rating Scale (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 Other protocol defined inclusion and exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flexible-dose of Lu AF35700<br> | Drug: Lu AF35700<br>* Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally. From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day) Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight, waist circumference and ECG) | From dosing to end of study (57 weeks) |