NOVA-2

21 evidence topics · 5 sources

Objective

Registered study purpose

“This is a Phase 3, randomized, double blind, placebo controlled, fixed dose, multicenter study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of LB-102 100 mg once daily (QD) and LB-102 50 mg QD versus placebo QD for the treatment of adult patients with an acute exacerbation of schizophrenia” (opens the source at this quote in a new tab)

Role in the registration program

“We initiated a six-week Phase 3 trial (NOVA-2) of LB-102 in participants with acute schizophrenia in March 2026, which we believe, if positive, may be sufficient to support a regulatory approval application along with our Phase 2 trial and other NDA-enabling activities.” (opens the source at this quote in a new tab)

“Based on positive results and prior FDA feedback, we believe NOVA-2, together with the open label extension trial, and data from our Phase 2 (NOVA-1) trial, will support the potential U.S. approval of LB-102 for the treatment of schizophrenia.” (opens the source at this quote in a new tab)
“Our Phase 3 trial, NOVA-2, is designed to further elucidate the potential multidimensional benefits of LB-102 across the positive, negative, and cognitive symptom domains of schizophrenia.” (opens the source at this quote in a new tab)

Location and study date

Study dates and status

Item	Registry record
Protocol number	“LB-102-008”
Study start (actual)	“2026-03-25”
Primary completion (estimated)	“2027-06”
Study completion (estimated)	“2027-10”
Last update posted	“2026-07-27”

Sites: United States only

“We are conducting this trial entirely in the United States at approximately 25 sites, a similar number of sites as were utilized in our Phase 2 acute schizophrenia trial and there is a significant overlap between the sites utilized in our Phase 2 trial and those we are utilizing in the Phase 3 trial.” (opens the source at this quote in a new tab)

“This study has 13 locations” (opens the source at this quote in a new tab)

Topline results timing: guidance at initiation

“Topline results from NOVA-2 are anticipated in the second half of 2027 and if positive, the company expects to hold a pre-NDA meeting with FDA thereafter.” (opens the source at this quote in a new tab)

Topline results timing: guidance revised in July 2026

“based on enrollment projections, it now expects to report topline results from the pivotal Phase 3 NOVA-2 clinical trial of LB-102 in patients with schizophrenia in the first half of 2027 and to schedule a pre-NDA meeting with the FDA thereafter in the second half of 2027.” (opens the source at this quote in a new tab)
“Enrollment in our pivotal Phase 3 NOVA-2 trial has been more rapid than we expected” (opens the source at this quote in a new tab)

“Phase 3 topline data read out expected in 1H 2027” (opens the source at this quote in a new tab)

Study design

Official title and registered design

“A Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate the Antipsychotic Efficacy and Safety of LB 102 in the Treatment of Adult Patients With Acute Schizophrenia” (opens the source at this quote in a new tab)
“Patients will be randomized 1:1:1 to one of three treatments” (opens the source at this quote in a new tab)

Three-arm, inpatient, fixed-dose design without titration

“The Phase 3 trial is a three-arm, inpatient, double-blinded, placebo-controlled, oral once-daily dose of LB-102 in patients with acute schizophrenia, with a six-week treatment duration.” (opens the source at this quote in a new tab)
“All patients will start at their assigned dose level without titration.” (opens the source at this quote in a new tab)
“We designed our Phase 3 to leverage the operational framework of our Phase 2 trial.” (opens the source at this quote in a new tab)

Changes from the phase 2 trial

“Primary changes: 6-week duration; 3 versus 4 arms” (opens the source at this quote in a new tab)
“Doses selected to inform use in commercial setting” (opens the source at this quote in a new tab)

Measures to limit placebo response

“To mitigate the risk of an elevated placebo response in this trial, we are employing the same strategies which proved effective in our Phase 2 acute schizophrenia trial including consistent, frequent, and close engagement with clinical sites, the use of two third-party vendors (including the one used in our Phase 2 trial) to help identify and exclude professional patients from the trial, and a centralized review of PANSS ratings to ensure consistency and quality control throughout the trial.” (opens the source at this quote in a new tab)

Eligibility criteria

Inclusion criteria

Criterion	Quoted registry text
Age	“18 Years to 65 Years”
Diagnosis	“Diagnosis of schizophrenia as defined by DSM-5”
Symptom severity	“PANSS 80-120”
Body mass index	“BMI - 18-40”
Setting	“Willing to be hospitalized for duration of the study”

Exclusion criteria

Criterion	Quoted registry text
Treatment resistance	“History of resistant treatment to schizophrenia medications”
Symptom change before randomization	“Increase in PANSS of > 20% between screening and baseline”
Other psychiatric diagnosis	“DSM-5 diagnosis other than schizophrenia”
Suicide risk	“Risk of suicidal behavior”
Violence risk	“Risk of violent or destructive behavior”
Tardive dyskinesia	“Clinically significant tardive dyskinesia determined by a score of ≥3 on Item 8 of the AIMS at Screening”
Akathisia	“Score of ≥3 on the BARS global clinical assessment of akathisia at Screening”
Diabetes	“Insulin dependent diabetes”
Cardiac disease	“Known ischemic heart disease or any history of myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or coronary artery bypass surgery”

Treatment

Treatment arms

Arm	Quoted registry text
LB-102 50 mg	“LB-102 50 mg given orally for 6 weeks”
LB-102 100 mg	“LB-102 100 mg given orally for 6 weeks”
Placebo	“Placebo given orally for 6 weeks”
Dosage form	“LB-102 oral tablet given for six weeks”

Dose selection and randomization ratio

“To better inform potential future commercial use of LB-102, we are studying the effects of two doses, 50 mg LB-102 or 100 mg LB-102, versus placebo in this trial, and patients will be randomized in a 1:1:1 ratio across the three arms of the trial.” (opens the source at this quote in a new tab)

Permitted concomitant and rescue medications

No evidence found.

Study outcomes

Rationale for using PANSS total score as the primary endpoint

Primary outcome definition

“Change from baseline to Week 6 on the Positive and Negative Syndrome Scale” (opens the source at this quote in a new tab)
“Determine whether LB-102, demonstrates antipsychotic efficacy, as determined by a change from Baseline on the Positive and Negative Syndrome Scale (PANSS) total score, compared to placebo: increase in scale indicates worsening while a decrease in the scale likely indicates a response to treatment” (opens the source at this quote in a new tab)

“The primary endpoint of the trial is change from baseline in total PANSS score at Day 42.” (opens the source at this quote in a new tab)

Company rationale for the 6-week assessment

“potential to further improve PANSS reductions observed following treatment with LB-102 given that in our Phase 2 trial, the PANSS score in the LB-102 treated arms declined at a faster rate than placebo through the 28-day duration of our Phase 2 trial.” (opens the source at this quote in a new tab)

Secondary outcomes: registry record

Secondary outcome	Time frame
“Evaluate the Safety and Tolerability of LB-102”	“10 weeks”
“Change in Clinical Global Impressions-Severity of Illness scale (CGI-S)”	“6 weeks”

Secondary endpoints: company statements

“Secondary endpoints include Clinical Global Impression-Severity (CGI-S), PANSS positive and negative subscales, Marder factor scores, cognitive performance, and Personal and Social Performance (PSP) scale.” (opens the source at this quote in a new tab)

Key secondary endpoint hierarchy and multiplicity control

No evidence found.

Statistical analysis description

Number of participants (Planned and analyzed)

Planned enrollment: registry record

Enrollment type	Participants
Estimated	“456”

Planned enrollment: company statements

“The trial is designed to enroll approximately 460 patients with acute exacerbation of schizophrenia at approximately 25 sites in the U.S.” (opens the source at this quote in a new tab)

“The sample size will be approximately 460 patients.” (opens the source at this quote in a new tab)

Power and effect size assumptions

No evidence found.

Analyzed population

No evidence found.

Description of analysis sets

No evidence found.

Results

Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results

No evidence found.

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

No evidence found.

Study limitations

Summary

NOVA-2 is recruiting and has reported no results. The registry record lists an estimated primary completion of June 2027, and the company expects topline results in the first half of 2027. Planned enrollment is 456 participants in the registry record and approximately 460 in company statements, randomized 1:1:1 to LB-102 50 mg, LB-102 100 mg, or placebo for 6 weeks of inpatient treatment at sites in the United States only. The 75 mg dose studied in NOVA-1 is absent from this trial. The trial has no active comparator, lasts 6 weeks, and excludes participants with a history of treatment resistance, so it will provide no comparative, maintenance, or treatment-resistant evidence. The registry record lists 2 secondary outcomes (adverse events and CGI-S), and company statements add PANSS subscales, Marder factor scores, cognitive performance, and the Personal and Social Performance scale. The testing hierarchy, power assumptions, and analysis sets have not been disclosed. The registry record listed 13 locations at its July 2026 update, and company statements describe approximately 25 sites.