52-week Open Label Safety-Tolerability Study

NCT07369154
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
900
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Lead sponsor
LB Pharmaceuticals Inc.
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Start date
2026-04-23
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Number of sites
23
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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
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Acronym
NOVA3
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Short title
52-week Open Label Safety-Tolerability Study
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Official title
A 52 Week, Open Label Safety and Tolerability Study of LB-102 in Adult Patients With Schizophrenia
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-04-01
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First posted
2026-01-27
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Registry last updated
2026-09-09
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Primary completion date
2028-12-01
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Start date
2026-04-23
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Participants
900
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Participant count basis
Estimated
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Planned participants
900
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Protocol amendments
1
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Number of sites
23
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
LB Pharmaceuticals Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07369154
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07369154
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No

  • Provide ICF
  • Patients clinically stable PANSS </= 80 at screening
  • CGI-S </+ 3 at screening
  • Medically stable
  • BMI 18 -40
  • Taking oral antipsychotic treatment for at least 30 days
  • Have stable living environment

  • Sexually active M/F patients not willing to use highly effective contraception
  • Breast feeding
  • History of treatment resistance to schizophrenia medications
  • DSM-5 current diagnosis other than schizophrenia
  • Risk of suicidal behavior
  • History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other
Sources for eligibility
clinicaltrials.gov

  • Chandler Clinical TrialsChandler, United StatesRecruiting
  • Pillar Clinical ResearchBentonville, United StatesRecruiting
  • Pillar Clinical ResearchLittle Rock, United StatesRecruiting
  • Woodland International Research GroupLittle Rock, United StatesRecruiting
  • Advanced Research CenterAnaheim, United StatesRecruiting
  • Synapse Clinical TrialsCerritos, United StatesRecruiting
  • ProScience Research GroupCulver City, United StatesRecruiting
  • CenExelCulver City, United StatesRecruiting
  • Synergy San DiegoSan Diego, United StatesRecruiting
  • CenExelHollywood, United StatesRecruiting
  • Segal TrialsMiami Lakes, United StatesRecruiting
  • Health Synergy Clinical ResearchWest Palm Beach, United StatesRecruiting
  • CenExelAtlanta, United StatesRecruiting
  • Accelerated Clinical TrialSnellville, United StatesRecruiting
  • Pillar Clinical ResearchChicago, United StatesRecruiting
  • CenExel GaithersburgGaithersburg, United StatesRecruiting
  • Arch Clinical TrialsSt Louis, United StatesRecruiting
  • Redbird ResearchLas Vegas, United StatesRecruiting
  • Neuro-Behavioral Clinical ResearchNew York, United StatesRecruiting
  • Neuro-Behavioral Clinical ResearchCanton, United StatesRecruiting
  • Adams ClinicalPhiladelphia, United StatesRecruiting
  • Adams ClinicalDeSoto, United StatesRecruiting
  • Pillar Clinical ResearchRichardson, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)