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Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Enrolling by invitation
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
WID-RGC20(Cariprazine) 3mg/day
WID-RGC20(Cariprazine) 6mg/day
Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day
Sponsored by
Whanin Pharmaceutical Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

19 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female patients 19 ≤ age < 65 years
  • At least 1 year of schizophrenia diagnosed according to DSM-5 criteria(295.90)
  • At least 1 psychotic episode within 1 year
  • Current psychotic episode(acute exacerbation of schizophrenia) within 2 weeks
  • 80 ≤ PANSS total score ≤ 120
  • Rating of at least 4(moderate) on at least 2 of the following 4 PANSS positive symptoms
  • CGI-S score ≥ 4
  • Patients who can be hospitalized during the screening period and at least 3 weeks of the initial double-blind treatment phase

Exclusion Criteria:

  1. Psychiatric Criteria

    • Medical history except schizophrenia specified in protocol
    • First-episode psychosis
    • Treatment-resistant schizophrenia within 2 years
    • Positive result from the blood alcohol concentration(BAC) test or the urine drug screen(UDS)
    • Have suicide risk

  2. Treatment-related Criteria

    • Electroconvulsive therapy(ECT) within 12 weeks or Previous lack of response to ECT
    • Concomitant treatment with 3 or more antipsychotics within 12 weeks
    • Treatment with flunitrazepam or LAI antipsychotics less than 1 cycle or clozapine within 24 weeks
    • Treatment with CYP3A4 inducers or potent CYP3A4 inhibitors
    • Treatment with amiodarone or systemic corticosteroids for ≥ 12 weeks within 1 year
    • Required prohibited concomitant medication during the study period
    • Prior participation in any clinical trials of Cariprazine

  3. Other

    • Ophthalmic medical findings or related history(ex. uncontrolled diabetes or hypertension)
    • Abnormal laboratory findings specified in protocol
    • Not suitable for any other reason, as judged by the investigator

Sites / Locations

  • Whan In Pharm.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Cariprazine 3mg/day

Cariprazine 6mg/day

Placebo

Arm Description

WID-RGC20(Cariprazine) 3 mg/day

WID-RGC20(Cariprazine) 6 mg/day

Placebo for WID-RGC20(Cariprazine) 3 mg/day or 6mg/day

Outcomes

Primary Outcome Measures

Positive And Negative Syndrome Scale(PANSS) total score
Change from baseline in Positive And Negative Syndrome Scale(PANSS) total score at Week 6

Secondary Outcome Measures

Clinical Global Impressions-Severity(CGI-S)
Change from baseline in Clinical Global Impressions-Severity(CGI-S) at Week 6

Full Information

First Posted
November 26, 2021
Last Updated
December 8, 2021
Sponsor
Whanin Pharmaceutical Company
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1. Study Identification

Unique Protocol Identification Number
NCT05168007
Brief Title
Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Fixed-Dose, Phase 3 Clinical Trial Evaluating the Efficacy and Safety of WID-RGC20 3 mg/Day and 6 mg/Day in Patients With Acute Psychotic Episode of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 19, 2021 (Actual)
Primary Completion Date
July 17, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Whanin Pharmaceutical Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This Study is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Fixed-Dose, Phase 3 Clinical Trial Evaluating the Efficacy and Safety of WID-RGC20 3 mg/day and 6 mg/day in Patients with Acute Psychotic Episode of Schizophrenia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
342 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cariprazine 3mg/day
Arm Type
Experimental
Arm Description
WID-RGC20(Cariprazine) 3 mg/day
Arm Title
Cariprazine 6mg/day
Arm Type
Experimental
Arm Description
WID-RGC20(Cariprazine) 6 mg/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for WID-RGC20(Cariprazine) 3 mg/day or 6mg/day
Intervention Type
Drug
Intervention Name(s)
WID-RGC20(Cariprazine) 3mg/day
Intervention Description
The initial dose is WID-RGC20(Cariprazine) 1.5mg/day, followed by an up-titration of 1.5mg/day until the target dose(3mg/day) is achieved. The investigational product is administered during the double-blind treatment period(6 weeks).
Intervention Type
Drug
Intervention Name(s)
WID-RGC20(Cariprazine) 6mg/day
Intervention Description
The initial dose is WID-RGC20(Cariprazine) 1.5mg/day, followed by an up-titration of 1.5mg/day until the target dose(6mg/day) is achieved. The investigational product is administered during the double-blind treatment period(6 weeks).
Intervention Type
Drug
Intervention Name(s)
Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day
Intervention Description
The placebo comparator is administered during the double-blind treatment period(6 weeks).
Primary Outcome Measure Information:
Title
Positive And Negative Syndrome Scale(PANSS) total score
Description
Change from baseline in Positive And Negative Syndrome Scale(PANSS) total score at Week 6
Time Frame
at Week 6
Secondary Outcome Measure Information:
Title
Clinical Global Impressions-Severity(CGI-S)
Description
Change from baseline in Clinical Global Impressions-Severity(CGI-S) at Week 6
Time Frame
at Week 6
Other Pre-specified Outcome Measures:
Title
Positive And Negative Syndrome Scale(PANSS) total score
Description
Change from baseline in Positive And Negative Syndrome Scale(PANSS) total score at Week 1, 2, 3, 4, 5
Time Frame
up to 5 weeks
Title
Clinical Global Impressions-Severity(CGI-S)
Description
Change from baseline in Clinical Global Impressions-Severity(CGI-S) at Week 1, 2, 3, 4, 5
Time Frame
up to 5 weeks
Title
Clinical Global Impressions-Improvement(CGI-I)
Description
Clinical Global Impressions-Improvement(CGI-I) at Week 1, 2, 3, 4, 5, 6
Time Frame
up to 6 weeks
Title
Positive And Negative Syndrome Scale(PANSS) positive score
Description
Change from baseline in Positive And Negative Syndrome Scale(PANSS) positive score by Week 6
Time Frame
up to 6 weeks
Title
Positive And Negative Syndrome Scale(PANSS) negative score
Description
Change from baseline in Positive And Negative Syndrome Scale(PANSS) negative score by Week 6
Time Frame
up to 6 weeks
Title
Positive And Negative Syndrome Scale(PANSS) responder
Description
Percentage of subjects with at least 30% reduction in the Positive And Negative Syndrome Scale(PANSS) total score at Week 6 compared with baseline
Time Frame
at Week 6
Title
Adverse event(AE)
Description
Incidence of Adverse event(AE)s by Week 8
Time Frame
up to 8 weeks
Title
Suicidal ideation and behavior
Description
Incidence of suicidal ideation and behavior by Week 8
Time Frame
up to 8 weeks
Title
Extrapyramidal Symptoms(EPS)
Description
Incidence of Extrapyramidal Symptoms(EPS) by Week 6
Time Frame
up to 6 weeks
Title
Laboratory test
Description
Change from baseline in clinical laboratory tests by Week 6
Time Frame
up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients 19 ≤ age < 65 years At least 1 year of schizophrenia diagnosed according to DSM-5 criteria(295.90) At least 1 psychotic episode within 1 year Current psychotic episode(acute exacerbation of schizophrenia) within 2 weeks 80 ≤ PANSS total score ≤ 120 Rating of at least 4(moderate) on at least 2 of the following 4 PANSS positive symptoms CGI-S score ≥ 4 Patients who can be hospitalized during the screening period and at least 3 weeks of the initial double-blind treatment phase Exclusion Criteria: Psychiatric Criteria Medical history except schizophrenia specified in protocol First-episode psychosis Treatment-resistant schizophrenia within 2 years Positive result from the blood alcohol concentration(BAC) test or the urine drug screen(UDS) Have suicide risk Treatment-related Criteria Electroconvulsive therapy(ECT) within 12 weeks or Previous lack of response to ECT Concomitant treatment with 3 or more antipsychotics within 12 weeks Treatment with flunitrazepam or LAI antipsychotics less than 1 cycle or clozapine within 24 weeks Treatment with CYP3A4 inducers or potent CYP3A4 inhibitors Treatment with amiodarone or systemic corticosteroids for ≥ 12 weeks within 1 year Required prohibited concomitant medication during the study period Prior participation in any clinical trials of Cariprazine Other Ophthalmic medical findings or related history(ex. uncontrolled diabetes or hypertension) Abnormal laboratory findings specified in protocol Not suitable for any other reason, as judged by the investigator
Facility Information:
Facility Name
Whan In Pharm.
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia

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