NOVA-3

18 evidence topics · 6 sources

Objective

Registered study purpose

“Phase 3, open label, multicenter study designed to assess the long term safety and tolerability of LB-102 for the treatment of adult patients with stable schizophrenia” (opens the source at this quote in a new tab)

Accrual of the safety population for the new drug application

“Concurrently with the Phase 3 NOVA-2 trial, we are enrolling an outpatient, open label trial (NOVA-3) to accrue the requisite safety population required to support NDA submission as well as other clinical trials and non-clinical studies typically required by FDA for an NDA approval.” (opens the source at this quote in a new tab)

“Although the primary objective of this trial is to collect the requisite safety data required for an NDA submission, we also expect to collect efficacy data in certain subsets of patients enrolled in this trial.” (opens the source at this quote in a new tab)

Location and study date

Study dates and status

Item	Registry record
Protocol number	“LB-102-010”
Study start (actual)	“2026-04-23”
Primary completion (estimated)	“2028-12”
Study completion (estimated)	“2029-04”
Last update posted	“2026-09-09”

Registered locations

“This study has 23 locations” (opens the source at this quote in a new tab)

Enrollment status in August 2026

“The 52-week open-label safety and tolerability trial (NOVA-3), evaluating the long-term safety and tolerability of LB-102 in patients with stable schizophrenia, is enrolling eligible patients who have completed NOVA-2, as well as de novo patients.” (opens the source at this quote in a new tab)

Study design

Official title and registered design

“A 52 Week, Open Label Safety and Tolerability Study of LB-102 in Adult Patients With Schizophrenia” (opens the source at this quote in a new tab)
“Open label study” (opens the source at this quote in a new tab)

Enrollment of NOVA-2 completers and new participants

“Patients who complete NOVA-2 will be able to continue in the Open Label Extension trial that will also enroll de novo patients.” (opens the source at this quote in a new tab)

“we expect to initiate an open label trial in patients with stable schizophrenia that will enroll both patients who participated in the Phase 3 trial as well as patients who did not.” (opens the source at this quote in a new tab)

“~900 patients – rollover from Phase 3 trial + new patients” (opens the source at this quote in a new tab)

Eligibility criteria

Target population

“adult patients with stable schizophrenia who are experiencing inadequate response or who are having issues with side effects, general tolerability, or overall effectiveness of their current antipsychotic medication and desire to change medications, or who have completed their participation in current LB-102 clinical studies” (opens the source at this quote in a new tab)

Inclusion criteria

Criterion	Quoted registry text
Age	“18 Years to 65 Years”
Symptom severity	“Patients clinically stable PANSS </= 80 at screening”
Global severity	“CGI-S </+ 3 at screening”
Medical status	“Medically stable”
Body mass index	“BMI 18 -40”
Current treatment	“Taking oral antipsychotic treatment for at least 30 days”
Living situation	“Have stable living environment”

Exclusion criteria

Criterion	Quoted registry text
Treatment resistance	“History of treatment resistance to schizophrenia medications”
Other psychiatric diagnosis	“DSM-5 current diagnosis other than schizophrenia”
Suicide risk	“Risk of suicidal behavior”
Breastfeeding	“Breast feeding”

Treatment

Flexible dosing between 50 mg and 100 mg

“LB-102 flexible dosing 50 mg - 100 mg” (opens the source at this quote in a new tab)

Switching from the prior antipsychotic

No evidence found.

Study outcomes

Rationale for using long-term safety and tolerability as the primary endpoint

Primary outcome definition

“Evaluate long term safety and tolerability of LB-102 by evaluating the number of adverse event, incidence of treatment emergent events.” (opens the source at this quote in a new tab)
“Overall adverse events, serious adverse events, incidence of treatment emergent events and adverse events which lead to study discontinuation” (opens the source at this quote in a new tab)
“52 weeks” (opens the source at this quote in a new tab)

Exposure requirements for the safety database

“To support approval, the safety population must include at least 1,500 cumulative patient exposures to LB-102, including at least 100 patients with greater than or equal to one year of exposure and 300 patients with greater than or equal to six months of exposure.” (opens the source at this quote in a new tab)

Secondary outcomes

Secondary outcome description	Time frame
“Evaluating the safety of treatment by number of adverse events”	“52 weeks”
“Evaluating the safety of treatment by change in vital signs, electrocardiogram (QTC), and weight/height for BMI”	“52 weeks”
“Evaluating the safety of treatment by conducting physical examinations”	“52 weeks”
“Assess the long-term effectiveness determined by Positive and Negative Syndrome Scale (PANSS)”	“52 weeks”

Open-label efficacy assessments

“Efficacy measures will include periodic assessments of cognitive performance as well as open label assessments of improvements in positive and negative symptoms, including in patients with prominent negative symptoms at enrollment in the trial.” (opens the source at this quote in a new tab)
“Although we do not expect data from this open label trial to lead to product label claims without additional randomized clinical trials, we believe these data have the potential to further support the differentiation of LB-102” (opens the source at this quote in a new tab)

Statistical analysis description

Number of participants (Planned and analyzed)

Planned enrollment: registry record

Enrollment type	Participants
Estimated	“900”

Planned enrollment: company statement

“As a result, we expect to enroll approximately 900 patients in our planned open label safety trial.” (opens the source at this quote in a new tab)

Number of participants entering from NOVA-2

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-3 is a single-group, open-label trial with no concurrent control and has reported no results. The registry record lists an estimated primary completion of December 2028. Planned enrollment is 900 participants, drawn from participants who completed NOVA-2 and from newly enrolled adults with stable schizophrenia who have taken an oral antipsychotic for at least 30 days. Dosing is flexible between 50 mg and 100 mg, so the long-term exposure at each dose will depend on investigator dose selection. PANSS and cognitive assessments are unblinded, and the company states that it does not expect these data to support label claims without additional randomized trials. The number of participants expected to enter from NOVA-2, the visit schedule, and the analysis sets have not been disclosed.