Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia (NOVA2)

LB Pharmaceuticals

Status and phase: Begins enrollment this month; Phase 3

Conditions: Schizophrenia

Treatments: Other: Placebo; Drug: LB-102 (100 mg tablet); Drug: LB-102 (50 mg tablet)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07363577

LB-102-008

Details and patient eligibility

About

This is a Phase 3, randomized, double blind, placebo controlled, fixed dose, study designed to evaluate the efficacy, safety, tolerability, and of LB-102 versus placebo for the treatment of adult patients with an acute exacerbation of schizophrenia.

Full description

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

Enrollment: 456 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to provide ICF
• Willing to be hospitalized for duration of the study
• Diagnosis of schizophrenia as defined by DSM-5
• BMI - 18-40
• PANSS 80-120

Exclusion criteria

• Sexually active m/f not willing to adhere to highly effect birth control
• Breast feeding
• Increase in PANSS of > 20% between screening and baseline
• History of resistant treatment to schizophrenia medications
• DSM-5 diagnosis other than schizophrenia
• Risk of suicidal behavior
• Risk of violent or destructive behavior
• Clinically significant tardive dyskinesia determined by a score of ≥3 on Item 8 of the AIMS at Screening
• Score of ≥3 on the BARS global clinical assessment of akathisia at Screening
• Insulin dependent diabetes
• Known ischemic heart disease or any history of myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or coronary artery bypass surgery
• History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the patient

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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456 participants in 3 patient groups, including a placebo group

LB-102 (50 mg tablet)

Experimental group

Description:

• LB-102 50 mg given orally for 6 weeks

Treatment:

Drug: LB-102 (50 mg tablet)

LB-102 (100 mg tablet)

Experimental group

Description:

LB-102 100 mg given orally for 6 weeks

Treatment:

Drug: LB-102 (100 mg tablet)

Placebo

Placebo Comparator group

Description:

Placebo given orally for 6 weeks

Treatment:

Other: Placebo