52-week Open Label Safety-Tolerability Study (NOVA3)

LB Pharmaceuticals

Status and phase: Begins enrollment in 1 month; Phase 3

Conditions: Schizophrenia

Treatments: Drug: LB-102

Study type: Interventional

Funder types: Industry

Identifiers

NCT07369154

LB-102-010

Details and patient eligibility

About

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

Full description

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 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

Enrollment: 900 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provide ICF
• Patients clinically stable PANSS </= 70 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

900 participants in 1 patient group

LB-102

Other group

Description:

An open label study

Treatment:

Drug: LB-102