Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative Symptoms

Study Overview
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Brief Summary
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A study to evaluate the long-term safety and tolerability of flexible doses of Lu AF11167 in patients with schizophrenia during the 24-week treatment period

Official Title
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Interventional, Open-label, Flexible-dose, Long-term Safety Extension Study of Lu AF11167 in Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Lu AF11167


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient completed Study 17972A. The patient and the patient's caregiver or identified responsible person is able to read and understand the Informed Consent Form. The patient has signed the Informed Consent Form specific for Study 17972B. The patient can potentially benefit from 24 weeks of treatment with Lu AF11167 according to the investigator's clinical judgment. Exclusion Criteria: The patient has any current primary psychiatric disorder other than schizophrenia diagnosed during study 17972A The patient, in the opinion of the investigator, is at significant risk of suicide Other in- 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: Lu AF11167<br> | Drug: Lu AF11167<br>* Lu AF11167 - 2 or 4 mg/day; tablets, orally<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 (clinical safety laboratory tests, vital signs, BMI, waist, weight, ECG parameters) | From baseline week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Brief Negative Symptom Scale (BNSS) total score | The BNSS is a brief clinician rating scale, intended to measure negative symptoms. It consists of 13 items organized into 6 subscales: anhedonia, distress, asociality, avolition, blunted affect, and alogia. The items score the impairment. Items 1 to 4 are rated from 0 (Normal) to 6 (Extremely severe) and items 5 to 13 are rated from 0 (No impairment) to 6 (Severe deficit). The BNSS total score is calculated by summing the 13 individual items; subscale scores are calculated by summing the individual items within each subscale. Users of the BNSS should have training in psychiatric interview techniques and have clinical experience working with patients with schizophrenia and related psychotic disorders. The BNSS total scores ranges from 0 to 78. | from baseline to Week 24 | 
| Change in Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptoms Factor Score | The PANSS is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS includes 3 sub-scales and 30 items: 7 items make up the positive scale (for example: delusions, conceptual disorganization and hallucinatory behaviour), 7 items make up the negative scale (for example: blunted affect, emotional withdrawal and poor rapport) and 16 items make up the general psychopathology scale (for example: somatic concern, anxiety and guilt feelings). Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). The PANSS total score is the sum of all items, and ranges from 30 to 210. Subscale scores are the sum of items within each subscale. | from baseline to Week 24 | 
| Change in PANSS Negative subscale score | The PANSS is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS includes 3 sub-scales and 30 items: 7 items make up the positive scale (for example: delusions, conceptual disorganization and hallucinatory behaviour), 7 items make up the negative scale (for example: blunted affect, emotional withdrawal and poor rapport) and 16 items make up the general psychopathology scale (for example: somatic concern, anxiety and guilt feelings). Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). The PANSS total score is the sum of all items, and ranges from 30 to 210. Subscale scores are the sum of items within each subscale. | from baseline to Week 24 | 
| Change in CGI-SCH-S negative symptoms score | The CGI-SCH is a clinician-rated scale to assess global illness severity and degree of change in patients with schizophrenia. For both the global illness severity and degree of change, the CGI-SCH consists of four different groups of symptoms (positive, negative, cognitive, and depressive) and the overall severity of the disorder. The CGI-SCH-severity of illness symptoms and overall severity are rated on a 7-point scale ranging from 1 (normal - not ill) to 7 (Among the most severely ill). For the first four ratings (positive, negative, depressive, and cognitive symptoms), the assessment should focus on the severity of symptoms only. Additionally, for 'overall severity' rating, both severity of symptoms and interference with functioning should be considered. | from baseline to Week 24 | 
| CGI-SCH-DC negative symptoms score | The CGI-SCH is a clinician-rated scale to assess global illness severity and degree of change in patients with schizophrenia. For both the global illness severity and degree of change, the CGI-SCH consists of four different groups of symptoms (positive, negative, cognitive, and depressive) and the overall severity of the disorder. The CGI-SCH-degree of change symptoms and overall severity are rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Each single rating (conditions of severity and degree of change) and overall ratings of severity and improvement are scored independently and no total score is derived. | at Week 24 | 
| CGI-SCH-DC negative symptoms response | The CGI-SCH is a clinician-rated scale to assess global illness severity and degree of change in patients with schizophrenia. For both the global illness severity and degree of change, the CGI-SCH consists of four different groups of symptoms (positive, negative, cognitive, and depressive) and the overall severity of the disorder. The CGI-SCH-degree of change symptoms and overall severity are rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Each single rating (conditions of severity and degree of change) and overall ratings of severity and improvement are scored independently and no total score is derived.CGI-SCH-DC negative symptoms response is defined as a CGI-SCH-DC negative symptoms score of 1 or 2. | at Week 24 |