Evaluating Safety and Efficacy of VV119 in Acute Schizophrenia Adults

NCT07703956 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: VV119-SCH-II-01
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change From Baseline in PANSS Positive Score at Week 6

  Baseline and Week 6

• Change From Baseline in PANSS Negative Score at Week 6

  Baseline and Week 6

• Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 6

  Baseline and Week 6

• Clinical Global Impression - Improvement (CGI-I) Score at Week 6

  Week 6

• Response Rate at Week 6

  Week 6

Study Arms (3)

VV119 capsules

EXPERIMENTAL

Capsule, 2 mg/4 mg /6 mg, administered orally once daily for 6 consecutive weeks

Drug: VV119 2mg; Drug: VV119 4mg; Drug: VV119 6mg

Active Comparator

ACTIVE COMPARATOR

Tablet, 20 mg , administered orally once daily for 6 consecutive weeks

Drug: Aripiprazole tablet

Placebo

PLACEBO COMPARATOR

Capsule/Tablet, administered orally once daily for 6 consecutive weeks

Drug: Placebo

Interventions

VV119 2mg DRUG

VV119 capsules 1 capsule (2mg/capsule) + VV119 capsules placebo 2 capsules + aripiprazole tablet placebo 2 tablets

Also known as: Low-dose group

VV119 capsules

VV119 4mg DRUG

VV119 capsules 2 capsules (2mg/capsule) + VV119 capsules placebo 1 capsules + aripiprazole tablet placebo 2 tablets

Also known as: Medium-dose group

VV119 capsules

VV119 6mg DRUG

VV119 capsule 3 capsules (2mg/capsule) + aripiprazole tablet placebo 2 tablets

Also known as: High-dose group

VV119 capsules

Aripiprazole tablet DRUG

VV119 capsule placebo 3 capsules (2mg/capsule) + aripiprazole tablet 2 tablets

Also known as: Active Comparator

Active Comparator

Placebo DRUG

VV119 capsule placebo 3 capsules (2mg/capsule) + aripiprazole tablet placebo 2 tablets

Also known as: Placebo Comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants, 18-65 years,inclusive, at screening.
• 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).
• 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).
• 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.
• 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).
• 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.
• 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.

You may not qualify if:

• Any primary DSM-5 disorder other than schizophrenia.
• 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.
• 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).
• Electroconvulsive therapy (ECT) within 3 months before screening.
• Chronic clozapine use prior to screening.
• 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.
• Long-acting injectable antipsychotics (risperidone paliperidone palmitate, aripiprazole long-acting injectable, etc.) discontinued for less than 5 half-lives at randomization.
• 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.
• 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.
• Prior inadequate response to aripiprazole (≥20 mg/day for minimum 6 weeks).
• History or active epilepsy (febrile convulsions excluded).
• History or current presence of neuroleptic malignant syndrome (NMS).
• History or active malignancy of any type.
• History or active ocular disease: open/closed-angle glaucoma, or acute bacterial/viral eye infection within 1 week pre-screening.
• History or active tardive dyskinesia.

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (1)

Beijing Anding Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Population Groups; Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Wang Gang

  Beijing Anding Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duan Huaqing

CONTACT

+86-18061926005; huaqing.duan@vigonvita.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 15, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)