Trial Outcomes & Findings for Randomized, Double-blinded, Placebo-controlled, Evaluating the Treatment With LB-102 in Patients With Acute Schizophrenia (NCT NCT06179108)
NCT ID: NCT06179108
Last Updated: 2025-10-22
Results Overview
The Positive and Negative Syndrome Scale (PANSS) is a scale used for measuring symptom severity of patients with schizophrenia. The PANSS rating is composed of 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Patients are scored from 1 to 7 on each symptom scale. The total score of the PANSS is a minimum of 30 and a maximum of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms whereas a higher PANSS total value represents a worse outcome
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
359 participants
Primary outcome timeframe
Baseline to Day 28 (4 weeks)
Results posted on
2025-10-22
Participant Flow
Participant milestones
| Measure |
LB-102, 50 mg QD
Oral LB-102: 50 mg (n = 107)
|
LB-102, 75 mg QD
Oral LB-102: 75 mg (n = 108)
|
LB-102, 100 mg QD
Oral LB-102: 100 mg (n = 36)
|
Placebo Comparator
Matched placebo tablets (n = 108)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
107
|
108
|
36
|
108
|
|
Overall Study
COMPLETED
|
76
|
80
|
22
|
83
|
|
Overall Study
NOT COMPLETED
|
31
|
28
|
14
|
25
|
Reasons for withdrawal
| Measure |
LB-102, 50 mg QD
Oral LB-102: 50 mg (n = 107)
|
LB-102, 75 mg QD
Oral LB-102: 75 mg (n = 108)
|
LB-102, 100 mg QD
Oral LB-102: 100 mg (n = 36)
|
Placebo Comparator
Matched placebo tablets (n = 108)
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
16
|
19
|
10
|
11
|
|
Overall Study
Lost to Follow-up
|
12
|
4
|
1
|
9
|
|
Overall Study
Adverse Event
|
2
|
3
|
3
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Randomized, Double-blinded, Placebo-controlled, Evaluating the Treatment With LB-102 in Patients With Acute Schizophrenia
Baseline characteristics by cohort
| Measure |
LB-102, 50 mg QD
n=107 Participants
1 tablet daily for 28 days
|
LB-102, 75 mg QD
n=108 Participants
1 tablet daily for 28 days
|
LB-102, 100 mg
n=36 Participants
1 tablet daily for 28 days
|
Placebo Comparator
n=108 Participants
1 tablet daily for 28 days
|
Total
n=359 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 9.64 • n=39 Participants
|
39.2 years
STANDARD_DEVIATION 9.17 • n=41 Participants
|
39.1 years
STANDARD_DEVIATION 9.19 • n=35 Participants
|
39.1 years
STANDARD_DEVIATION 9.11 • n=31 Participants
|
39.1 years
STANDARD_DEVIATION 9.26 • n=146 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
23 Participants
n=31 Participants
|
69 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=39 Participants
|
90 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
85 Participants
n=31 Participants
|
290 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
87 Participants
n=39 Participants
|
83 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
80 Participants
n=31 Participants
|
275 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
24 Participants
n=31 Participants
|
68 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
7 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 28 (4 weeks)Population: N for analyzed participants reflects all participants (i.e., including those with missing data imputed). Missing PANNS total scores were imputed using a mixture of MAR and MNAR approaches depending on the reason for missingness.
The Positive and Negative Syndrome Scale (PANSS) is a scale used for measuring symptom severity of patients with schizophrenia. The PANSS rating is composed of 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Patients are scored from 1 to 7 on each symptom scale. The total score of the PANSS is a minimum of 30 and a maximum of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms whereas a higher PANSS total value represents a worse outcome
Outcome measures
| Measure |
LB-102, 50 mg QD
n=107 Participants
Oral LB-102: 50 mg (n = 107)
|
LB-102, 75 mg QD
n=108 Participants
Oral LB-102: 75 mg (n = 108)
|
LB-102, 100 mg
n=36 Participants
Oral LB-102: 100 mg (n = 36)
|
Placebo Comparator
n=108 Participants
Matched placebo tablets (n = 108)
|
|---|---|---|---|---|
|
Change From Baseline to Week 4 in the PANSS Total Score
|
-14.28 score on a scale
Standard Error 1.097
|
-13.95 score on a scale
Standard Error 1.108
|
-16.08 score on a scale
Standard Error 1.906
|
-9.27 score on a scale
Standard Error 1.078
|
SECONDARY outcome
Timeframe: 28 daysPopulation: N for Analyzed participants reflects observed CGI-S data at Week 4.
The Clinical Global Impressions-Severity (CGI-S) rates illness severity on a scale from 1 to 7 and has been shown to correlate with PANSS. The CGI-S is rated on a 7-point scale commonly used in clinical settings and research to evaluate the severity of symptoms and treatment responses in patients with mental disorders. The CGI-S specifically focuses on the severity of illness at the time of assessment, where clinicians assess the patient's current condition relative to their past. The scoring is for the CGI-S:1-normal, not at all ill, 2-Borderline mentally ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, and 7-Extremely ill. The higher the score the more ill the patient is.
Outcome measures
| Measure |
LB-102, 50 mg QD
n=91 Participants
Oral LB-102: 50 mg (n = 107)
|
LB-102, 75 mg QD
n=83 Participants
Oral LB-102: 75 mg (n = 108)
|
LB-102, 100 mg
n=23 Participants
Oral LB-102: 100 mg (n = 36)
|
Placebo Comparator
n=94 Participants
Matched placebo tablets (n = 108)
|
|---|---|---|---|---|
|
Change From Baseline to Week 4 in the CGI-S Score
|
-.72 score on a scale
Standard Error 0.076
|
-.67 score on a scale
Standard Error 0.075
|
-.84 score on a scale
Standard Error 0.136
|
-.39 score on a scale
Standard Error 0.074
|
Adverse Events
LB-102, 50 mg QD
Serious events: 1 serious events
Other events: 74 other events
Deaths: 0 deaths
LB-102, 75 mg QD
Serious events: 1 serious events
Other events: 62 other events
Deaths: 0 deaths
LB-102, 100 mg QD
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo Comparator
Serious events: 2 serious events
Other events: 60 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
LB-102, 50 mg QD
n=107 participants at risk
Oral LB-102: 50 mg (n = 107)
|
LB-102, 75 mg QD
n=108 participants at risk
Oral LB-102: 75 mg (n = 108)
|
LB-102, 100 mg QD
n=36 participants at risk
Oral LB-102: 100 mg (n = 36)
|
Placebo Comparator
n=108 participants at risk
Matched placebo tablets (n = 108)
|
|---|---|---|---|---|
|
General disorders
Death
|
0.00%
0/107 • From Screening to study day 56
|
0.00%
0/108 • From Screening to study day 56
|
0.00%
0/36 • From Screening to study day 56
|
0.93%
1/108 • Number of events 1 • From Screening to study day 56
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/107 • From Screening to study day 56
|
0.00%
0/108 • From Screening to study day 56
|
2.8%
1/36 • Number of events 1 • From Screening to study day 56
|
0.93%
1/108 • Number of events 1 • From Screening to study day 56
|
|
Psychiatric disorders
Suicidal ideation
|
0.93%
1/107 • Number of events 1 • From Screening to study day 56
|
0.00%
0/108 • From Screening to study day 56
|
0.00%
0/36 • From Screening to study day 56
|
0.00%
0/108 • From Screening to study day 56
|
|
Nervous system disorders
Dystonia
|
0.00%
0/107 • From Screening to study day 56
|
0.93%
1/108 • Number of events 1 • From Screening to study day 56
|
0.00%
0/36 • From Screening to study day 56
|
0.00%
0/108 • From Screening to study day 56
|
Other adverse events
| Measure |
LB-102, 50 mg QD
n=107 participants at risk
Oral LB-102: 50 mg (n = 107)
|
LB-102, 75 mg QD
n=108 participants at risk
Oral LB-102: 75 mg (n = 108)
|
LB-102, 100 mg QD
n=36 participants at risk
Oral LB-102: 100 mg (n = 36)
|
Placebo Comparator
n=108 participants at risk
Matched placebo tablets (n = 108)
|
|---|---|---|---|---|
|
Endocrine disorders
Hyperprolactinaemia
|
3.7%
4/107 • Number of events 4 • From Screening to study day 56
|
1.9%
2/108 • Number of events 2 • From Screening to study day 56
|
8.3%
3/36 • Number of events 3 • From Screening to study day 56
|
0.00%
0/108 • From Screening to study day 56
|
|
Investigations
Blood prolactin increased
|
6.5%
7/107 • Number of events 7 • From Screening to study day 56
|
5.6%
6/108 • Number of events 6 • From Screening to study day 56
|
8.3%
3/36 • Number of events 3 • From Screening to study day 56
|
0.00%
0/108 • From Screening to study day 56
|
|
Psychiatric disorders
Insomnia
|
25.2%
27/107 • Number of events 37 • From Screening to study day 56
|
21.3%
23/108 • Number of events 27 • From Screening to study day 56
|
38.9%
14/36 • Number of events 14 • From Screening to study day 56
|
22.2%
24/108 • Number of events 31 • From Screening to study day 56
|
|
Nervous system disorders
Headache
|
11.2%
12/107 • Number of events 14 • From Screening to study day 56
|
8.3%
9/108 • Number of events 10 • From Screening to study day 56
|
5.6%
2/36 • Number of events 2 • From Screening to study day 56
|
9.3%
10/108 • Number of events 11 • From Screening to study day 56
|
|
Psychiatric disorders
Anxiety
|
9.3%
10/107 • Number of events 12 • From Screening to study day 56
|
8.3%
9/108 • Number of events 10 • From Screening to study day 56
|
11.1%
4/36 • Number of events 4 • From Screening to study day 56
|
8.3%
9/108 • Number of events 10 • From Screening to study day 56
|
|
Psychiatric disorders
Agitation
|
10.3%
11/107 • Number of events 50 • From Screening to study day 56
|
5.6%
6/108 • Number of events 19 • From Screening to study day 56
|
11.1%
4/36 • Number of events 4 • From Screening to study day 56
|
9.3%
10/108 • Number of events 29 • From Screening to study day 56
|
|
Investigations
Weight increased
|
12.1%
13/107 • Number of events 13 • From Screening to study day 56
|
7.4%
8/108 • Number of events 8 • From Screening to study day 56
|
8.3%
3/36 • Number of events 3 • From Screening to study day 56
|
3.7%
4/108 • Number of events 4 • From Screening to study day 56
|
|
Investigations
Blood creatine phosphokinase increased
|
3.7%
4/107 • Number of events 4 • From Screening to study day 56
|
0.93%
1/108 • Number of events 1 • From Screening to study day 56
|
5.6%
2/36 • Number of events 2 • From Screening to study day 56
|
2.8%
3/108 • Number of events 3 • From Screening to study day 56
|
|
Investigations
Alanine aminotransferase increased
|
2.8%
3/107 • Number of events 3 • From Screening to study day 56
|
0.93%
1/108 • Number of events 1 • From Screening to study day 56
|
5.6%
2/36 • Number of events 2 • From Screening to study day 56
|
0.93%
1/108 • Number of events 1 • From Screening to study day 56
|
|
Nervous system disorders
Somnolence
|
0.93%
1/107 • Number of events 1 • From Screening to study day 56
|
3.7%
4/108 • Number of events 4 • From Screening to study day 56
|
5.6%
2/36 • Number of events 2 • From Screening to study day 56
|
0.00%
0/108 • From Screening to study day 56
|
|
Gastrointestinal disorders
Constipation
|
3.7%
4/107 • Number of events 4 • From Screening to study day 56
|
0.93%
1/108 • Number of events 1 • From Screening to study day 56
|
5.6%
2/36 • Number of events 2 • From Screening to study day 56
|
0.00%
0/108 • From Screening to study day 56
|
Additional Information
Leslie Callahan, Head, Clinical Operations
LB Pharmaceuticals Inc
Phone: 9086556884
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place