> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/52-week-open-label-safety-tolerability-study-202d8269-5957-4a63-afe5-b22574f07e4b > Record changed: 2026-11-04 # 52-week Open Label Safety-Tolerability Study NCT07369154 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) Participants 900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) Lead sponsor LB Pharmaceuticals Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) Start date 2026-04-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) Number of sites 23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) ## Title and summary **Summary** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **Acronym** NOVA3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **Short title** 52-week Open Label Safety-Tolerability Study Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **Official title** A 52 Week, Open Label Safety and Tolerability Study of LB-102 in Adult Patients With Schizophrenia Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) ## Dates **Completion date** 2029-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **First posted** 2026-01-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **Registry last updated** 2026-09-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **Primary completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **Start date** 2026-04-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) ## Size and sites **Participants** 900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **Planned participants** 900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **Number of sites** 23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **Lead sponsor** LB Pharmaceuticals Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) ## Identifiers **Registry ID** NCT07369154 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **ClinicalTrials.gov ID** NCT07369154 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) ## Outcomes ### Primary outcomes 1. Evaluate long term safety and tolerability of LB-102 by evaluating the number of adverse event, incidence of treatment emergent events. Timeframe: 52 weeks Overall adverse events, serious adverse events, incidence of treatment emergent events and adverse events which lead to study discontinuation ### Secondary outcomes 1. Evaluate long term safety and tolerability Timeframe: 52 weeks Evaluating the safety of treatment by number of adverse events 2. Evaluate long term safety and tolerability Timeframe: 52 weeks Evaluating the safety of treatment by change in vital signs, electrocardiogram (QTC), and weight/height for BMI 3. Evaluate long term safety and tolerability Timeframe: 52 weeks Evaluating the safety of treatment by conducting physical examinations 4. Assess the long-term effectiveness determined by Positive and Negative Syndrome Scale (PANSS) Timeframe: 52 weeks Change in Positive and Negative Syndrome Scale (PANSS) from Baseline to end of treatment where a decrease in score likely indicate response to treatment whereas an increase in score may indicate a worsening of disease where an increase in the scale score may indicate a worsening of disease and decrease in score likely indicates response to treatment. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07369154) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** No ### Inclusion criteria - Provide ICF - Patients clinically stable PANSS