Evaluating Safety and Efficacy of VV119 in Acute Schizophrenia Adults

A Phase 2,Multicenter, Randomized, Double-blind, Placebo and Active Comparator Parallel-controlled Study to Evaluate the Safety and Efficacy of VV119 in Adults With Acute Schizophrenia

This will be a multicenter, randomized, double-blind, placebo and active comparator parallel-controlled study designed to assess the safety and efficacy of VV119 (2.0 to 6.0 mg) for the treatment of adult participants diagnosed with DSM-5 schizophrenia who are in an acute exacerbation phase.

Study Overview

• Status: Not yet recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: VV119 2mg; Drug: VV119 4mg; Drug: VV119 6mg; Drug: Aripiprazole tablet; Drug: Placebo

Detailed Description

Aripiprazole (20 mg) is included as a positive control to confirm the assay sensitivity of the study. The primary objective of the study is to assess the efficacy of VV119 in adult inpatients with a Diagnostic and Statistical Manual-Fifth Edition (DSM-5) diagnosis of schizophrenia. The secondary objective of the study is to assess overall safety of VV119 in adult inpatients diagnosed with DSM-5 schizophrenia.The exploratory objective is to characterize the population PK and quantify PK/PD relationship of VV119 in schizophrenia patients.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Duan Huaqing; Phone Number: +86-18061926005; Email: huaqing.duan@vigonvita.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Beijing Anding Hospital of Capital Medical University
      • Contact: Dong Fang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female participants, 18-65 years,inclusive, at screening.
2. Body Mass Index of 18.5 to 35.0kg/m2 , and body weight no less than 50.0kg (males), body weight no less than 45.0kg (females).
3. Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI).
4. Participant is experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months before screening:a.Participans who have been recently hospitalized or who would benefit from hospitalization for an acute exacerbation or relapse of schizophrenia;b.If hospitalized at screening, the participant's current admission for acute exacerbation shall be ≤2 weeks.

5. Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening,Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items at screening:

   Item 1 (P1; delusions) Item 2 (P2; conceptual disorganization) Item 3 (P3; hallucinatory behavior) Item 6 (P6; suspiciousness/persecution).

6. WOCBP and male participants and their partners shall use medically approved effective contraception throughout treatment and for 3 months after the final study drug dose, such as intrauterine devices, contraceptive pills, or condoms.
7. Participants who are able to understand and follow study plans and instructions; Participants who have voluntarily decided to participate in this study and signed the informed consent form.

Exclusion Criteria:

1. Any primary DSM-5 disorder other than schizophrenia.
2. Investigator-assessed treatment-resistant schizophrenia: participants who failed adequate sequential monotherapy with ≥2 structurally distinct, potent antipsychotics for positive symptoms,Each drug was given at ≥600 mg/day chlorpromazine equivalents for ≥6 consecutive weeks with poor efficacy.
3. Subjects with a >20% reduction in total PANSS score from screening to baseline. Reduction rate = (Screening total PANSS score - Baseline total PANSS score) / (Screening total PANSS score - 30).
4. Per investigator assessment via the Columbia-Suicide Severity Rating Scale (C-SSRS), participants with suicidal risk/intent in the 6 months before screening (answered "Yes" to C-SSRS Ideation Item 4 or 5) or any actual suicidal behavior within 12 months prior are excluded. Non-suicidal self-injury in the past year is not exclusionary, though participants with substantial current self-harm risk per clinical judgment will still be excluded.
5. Electroconvulsive therapy (ECT) within 3 months before screening.
6. Chronic clozapine use prior to screening.
7. Discontinuation of short/intermediate-acting antipsychotics or other psychoactive agents (antidepressants, mood stabilizers, antiepileptics, etc.) for less than 5 half-lives or less than 1 week at randomization.
8. Long-acting injectable antipsychotics (risperidone paliperidone palmitate, aripiprazole long-acting injectable, etc.) discontinued for less than 5 half-lives at randomization.
9. Discontinuation of QT-prolonging and torsades de pointes (TdP)-inducing medications (levofloxacin, fluconazole, ondansetron, amiodarone, metronidazole, erythromycin, haloperidol, etc.) for less than 5 half-lives at randomization.
10. Discontinuation of moderate/potent CYP3A or CYP2D6 inhibitors/inducers for less than 5 half-lives at randomization, or planned use of such agents throughout the study.
11. Prior inadequate response to aripiprazole (≥20 mg/day for minimum 6 weeks).
12. History or active epilepsy (febrile convulsions excluded).
13. History or current presence of neuroleptic malignant syndrome (NMS).
14. History or active malignancy of any type.
15. History or active ocular disease: open/closed-angle glaucoma, or acute bacterial/viral eye infection within 1 week pre-screening.
16. History or active tardive dyskinesia.
17. History of conditions/surgeries altering drug ADME or conferring safety risks (gastrectomy, gastrointestinal anastomosis, bowel resection, urinary obstruction, dysuria, etc.).
18. History of drug/food allergies, or hypersensitivity to study drug, its components, or aripiprazole analogs.
19. Pregnant or lactating female at screening/baseline.
20. History of alcohol/psychoactive substance abuse/dependence (excluding caffeine, nicotine) within 1 year pre-screening, or positive urine drug/alcohol screen at screening.
21. Clinically significant abnormal vital signs/physical exam findings at screening/baseline per investigator judgment that may interfere with study participation.
22. Orthostatic drop ≥20 mmHg systolic or ≥10 mmHg diastolic within 3 minutes of standing at screening.
23. QTcF >450 ms (male) / >470 ms (female) at screening/baseline (Fridericia formula); or other clinically significant 12-lead ECG abnormalities interfering with study participation per investigator.
24. Severe unstable medical illness (cardiac, hepatic, renal, hematologic, endocrine, neurologic, etc.) deemed ineligible by investigator.
25. Elevated ALT/AST >1.5×ULN, Cr >1.2×ULN, TBIL >1.5×ULN, or other clinically significant lab abnormalities at screening/baseline per investigator assessment.
26. Positive HBsAg, HCV-Ab, HIV-Ab or TP-Ab at screening.
27. Participation in another interventional trial with investigational product/device within 3 months pre-screening, or ongoing trial enrollment.
28. Other exclusion criteria per investigator discretion .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VV119 capsules; Capsule, 2 mg/4 mg /6 mg, administered orally once daily for 6 consecutive weeks	Drug: VV119 2mg; VV119 capsules 1 capsule (2mg/capsule) + VV119 capsules placebo 2 capsules + aripiprazole tablet placebo 2 tablets; Other Names: Low-dose group; Drug: VV119 4mg; VV119 capsules 2 capsules (2mg/capsule) + VV119 capsules placebo 1 capsules + aripiprazole tablet placebo 2 tablets; Other Names: Medium-dose group; Drug: VV119 6mg; VV119 capsule 3 capsules (2mg/capsule) + aripiprazole tablet placebo 2 tablets; Other Names: High-dose group
Active Comparator: Active Comparator; Tablet, 20 mg , administered orally once daily for 6 consecutive weeks	Drug: Aripiprazole tablet; VV119 capsule placebo 3 capsules (2mg/capsule) + aripiprazole tablet 2 tablets; Other Names: Active Comparator
Placebo Comparator: Placebo; Capsule/Tablet, administered orally once daily for 6 consecutive weeks	Drug: Placebo; VV119 capsule placebo 3 capsules (2mg/capsule) + aripiprazole tablet placebo 2 tablets; Other Names: Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6	The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants were rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.	Baseline and Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in PANSS Positive Score at Week 6	The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. The positive symptoms in schizophrenia are the excess or distortion of normal functions such as hallucinations, delusions, grandiosity, and hostility. Participants were rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.	Baseline and Week 6
Change From Baseline in PANSS Negative Score at Week 6	The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. The negative symptoms in schizophrenia are the diminution or loss of normal functions. Participants were rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.	Baseline and Week 6
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 6	The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the rater or investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" Response choices include the following: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.	Baseline and Week 6
Clinical Global Impression - Improvement (CGI-I) Score at Week 6	The rater or investigator rated the particpant's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant's condition at baseline prior to the first dose of double-blind study medication. Response choices included the following: 0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.	Week 6
Response Rate at Week 6	Response rate was defined as a reduction of ≥ 30% from baseline in PANSS Total Score	Week 6
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Score at Week 6	CDSS is a clinician-administered scale measuring depressive symptom severity in schizophrenia patients. It includes 9 items scored 0-3 per item, total scores range from 0 to 27. Higher scores mean worse depressive symptoms.	Baseline and Week 6

Collaborators and Investigators

• Sponsor: Vigonvita Life Sciences
• Investigators: Principal Investigator: Wang Gang, Beijing Anding Hospital of Capital Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 12, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 12, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Population Characteristics; Demography; Quinolones; Quinolines; Piperazines; Aripiprazole; Population Groups
• Other Study ID Numbers: VV119-SCH-II-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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