A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

Study Overview
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Brief Summary
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This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS 9070) during long-term treatment of subjects with stable schizophrenia.

Official Title
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A Phase 3, Multicenter, Extension of Study ALK9072-003 to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: ALKS 9072, Low
* Drug: ALKS 9072, High


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (Subjects who participated in ALK9072-003) Completed the ALK9072-003 Day 85 visit Continues to require treatment with an antipsychotic medication (New Subjects) On a stable dose of oral antipsychotic medication Diagnosis of chronic schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria that is clinically stable Has been able to achieve outpatient status for more than 3 months prior to screening Body Mass Index (BMI) of 18.5 to 40.0 kg/m2 (inclusive) Resides in a stable living situation Exclusion Criteria: (Subjects who participated in ALK9072-003) Abnormal clinical laboratory, vital sign, or electrocardiogram (ECG) finding during participation in study ALK9072-003 that was clinically relevant and related to study drug Missed more than 1 scheduled study visit during participation in study ALK9072-003 Has a significant or unstable medical condition that would preclude safe completion of the current study Subject is pregnant or breastfeeding Subject expects to be incarcerated in the next 12 months, or has pending legal action which may impact compliance with study participation or procedures (New Subjects) History of poor or inadequate clinical response to treatment with aripiprazole History of treatment resistance Diagnosis of current substance dependence (including alcohol) Pregnant, lactating, or breastfeeding Has received any long-acting intramuscular antipsychotic medication within 60 days prior to screening Currently under involuntary hospitalization Current or expected incarceration Additional inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALKS 9072, Low<br> | Drug: ALKS 9072, Low<br>* IM injection, given monthly<br>|
| Experimental: ALKS 9072, High<br> | Drug: ALKS 9072, High<br>* IM injection, given monthly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | This measure includes incidences >5%. | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S) | The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: 1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; and 7: among the most extremely ill patients. Results indicate a change in CGI-S score from baseline to Day 365 based on the observed data. | 52 weeks | 
| Discontinuation From Study Due to Adverse Events (AEs) | Number of subjects who discontinued the study due to AE. | 52 weeks | 
| Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is a questionnaire used for suicide assessment. Subjects are asked a series of questions that determine whether or not the patient demonstrates any suicidal ideation or behavior. The C-SSRS was administered to subjects at each study visit. | 52 weeks | 
| Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests | Includes incidence >2% but <5%. | 52 weeks | 
| Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores | This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale), 7 (positive/negative subscales), and 16 (general subscale); maximum scores (worst outcome) equals 210 (total scale), 49 (positive/negative subscales), and 112 (general subscale). | 52 weeks |