Evaluating Safety and Efficacy of VV119 in Acute Schizophrenia Adults
- 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.
- Short title
- Evaluating Safety and Efficacy of VV119 in Acute Schizophrenia Adults
- Official title
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2027-12-31
- First posted
- 2026-07-15
- Registry last updated
- 2026-07-15
- Primary completion date
- 2027-10-31
- Start date
- 2026-07-31
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Vigonvita Life Sciences
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07703956
- ClinicalTrials.gov ID
- NCT07703956
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
Timeframe: Baseline and 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.
Change From Baseline in PANSS Positive Score at Week 6
Timeframe: Baseline and 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.
Change From Baseline in PANSS Negative Score at Week 6
Timeframe: Baseline and 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.
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 6
Timeframe: Baseline and 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.
Clinical Global Impression - Improvement (CGI-I) Score at Week 6
Timeframe: 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.
Response Rate at Week 6
Timeframe: Week 6
Response rate was defined as a reduction of ≥ 30% from baseline in PANSS Total Score
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Score at Week 6
Timeframe: Baseline and 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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Healthy volunteers
- No
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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).
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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).
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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.
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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).
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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.
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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.
- 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).
- 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.
- 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.
- History of conditions/surgeries altering drug ADME or conferring safety risks (gastrectomy, gastrointestinal anastomosis, bowel resection, urinary obstruction, dysuria, etc.).
- History of drug/food allergies, or hypersensitivity to study drug, its components, or aripiprazole analogs.
- Pregnant or lactating female at screening/baseline.
- History of alcohol/psychoactive substance abuse/dependence (excluding caffeine, nicotine) within 1 year pre-screening, or positive urine drug/alcohol screen at screening.
- Clinically significant abnormal vital signs/physical exam findings at screening/baseline per investigator judgment that may interfere with study participation.
- Orthostatic drop ≥20 mmHg systolic or ≥10 mmHg diastolic within 3 minutes of standing at screening.
- 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.
- Severe unstable medical illness (cardiac, hepatic, renal, hematologic, endocrine, neurologic, etc.) deemed ineligible by investigator.
- 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.
- Positive HBsAg, HCV-Ab, HIV-Ab or TP-Ab at screening.
- Participation in another interventional trial with investigational product/device within 3 months pre-screening, or ongoing trial enrollment.
- Other exclusion criteria per investigator discretion .
- Beijing Anding Hospital of Capital Medical UniversityBeijing, China
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Schizophrenia Primary condition