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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: WID-RGC20(Cariprazine) 3mg/day; Drug: WID-RGC20(Cariprazine) 6mg/day; Drug: Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day

• Study Type: Interventional
• Enrollment (Anticipated): 342
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Whan In Pharm.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cariprazine 3mg/day; WID-RGC20(Cariprazine) 3 mg/day	Drug: WID-RGC20(Cariprazine) 3mg/day; 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).
EXPERIMENTAL: Cariprazine 6mg/day; WID-RGC20(Cariprazine) 6 mg/day	Drug: WID-RGC20(Cariprazine) 6mg/day; 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).
PLACEBO_COMPARATOR: Placebo; Placebo for WID-RGC20(Cariprazine) 3 mg/day or 6mg/day	Drug: Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day; The placebo comparator is administered during the double-blind treatment period(6 weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive And Negative Syndrome Scale(PANSS) total score	Change from baseline in Positive And Negative Syndrome Scale(PANSS) total score at Week 6	at Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impressions-Severity(CGI-S)	Change from baseline in Clinical Global Impressions-Severity(CGI-S) at Week 6	at Week 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive And Negative Syndrome Scale(PANSS) total score	Change from baseline in Positive And Negative Syndrome Scale(PANSS) total score at Week 1, 2, 3, 4, 5	up to 5 weeks
Clinical Global Impressions-Severity(CGI-S)	Change from baseline in Clinical Global Impressions-Severity(CGI-S) at Week 1, 2, 3, 4, 5	up to 5 weeks
Clinical Global Impressions-Improvement(CGI-I)	Clinical Global Impressions-Improvement(CGI-I) at Week 1, 2, 3, 4, 5, 6	up to 6 weeks
Positive And Negative Syndrome Scale(PANSS) positive score	Change from baseline in Positive And Negative Syndrome Scale(PANSS) positive score by Week 6	up to 6 weeks
Positive And Negative Syndrome Scale(PANSS) negative score	Change from baseline in Positive And Negative Syndrome Scale(PANSS) negative score by Week 6	up to 6 weeks
Positive And Negative Syndrome Scale(PANSS) responder	Percentage of subjects with at least 30% reduction in the Positive And Negative Syndrome Scale(PANSS) total score at Week 6 compared with baseline	at Week 6
Adverse event(AE)	Incidence of Adverse event(AE)s by Week 8	up to 8 weeks
Suicidal ideation and behavior	Incidence of suicidal ideation and behavior by Week 8	up to 8 weeks
Extrapyramidal Symptoms(EPS)	Incidence of Extrapyramidal Symptoms(EPS) by Week 6	up to 6 weeks
Laboratory test	Change from baseline in clinical laboratory tests by Week 6	up to 6 weeks

Collaborators and Investigators

• Sponsor: Whanin Pharmaceutical Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 19, 2021
• Primary Completion (ANTICIPATED): July 17, 2023
• Study Completion (ANTICIPATED): July 31, 2023

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (ACTUAL): December 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Cariprazine
• Other Study ID Numbers: WID-RGC20-P3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No