Trial Outcomes & Findings for Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients (NCT NCT03895437)
NCT ID: NCT03895437
Last Updated: 2026-05-20
Results Overview
The primary outcome is the TOL-3021 treatment effect as determined by a repeated measures analysis of change from baseline in the log-transformed MMTT C-peptide AUC at 12, 16, and 24 weeks
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
78 participants
Primary outcome timeframe
Baseline,12,16 and 24 weeks
Results posted on
2026-05-20
Participant Flow
Participant milestones
| Measure |
TOL-3021
TOL-3021 2 mg/mL
TOL-3021: TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene.
|
TOL-3021 Placebo
TOL-3021 Placebo
TOL-3021 Placebo: TOL-3021 Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
27
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
51
|
27
|
Reasons for withdrawal
| Measure |
TOL-3021
TOL-3021 2 mg/mL
TOL-3021: TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene.
|
TOL-3021 Placebo
TOL-3021 Placebo
TOL-3021 Placebo: TOL-3021 Placebo
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
51
|
27
|
Baseline Characteristics
Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients
Baseline characteristics by cohort
| Measure |
TOL-3021
n=51 Participants
TOL-3021 2 mg/mL
TOL-3021: TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene.
|
TOL-3021 Placebo
n=27 Participants
TOL-3021 Placebo
TOL-3021 Placebo: TOL-3021 Placebo
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=30 Participants
|
27 Participants
n=30 Participants
|
78 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Age, Continuous
|
27.1 years
n=30 Participants
|
26.5 years
n=30 Participants
|
26.8 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=30 Participants
|
11 Participants
n=30 Participants
|
38 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=30 Participants
|
16 Participants
n=30 Participants
|
40 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
8 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=30 Participants
|
24 Participants
n=30 Participants
|
70 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=30 Participants
|
25 Participants
n=30 Participants
|
71 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=30 Participants
|
27 participants
n=30 Participants
|
78 participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Baseline,12,16 and 24 weeksPopulation: Intent to Treat (ITT) Interim analysis cohort. The study was terminated following an interim analysis conducted after at least 30 TOL-3021 subjects had completed their Week 24 visit. The Data Safety Monitoring Board (DSMB) determined that the investigational drug showed no efficacy relative to placebo and recommended termination of the study.
The primary outcome is the TOL-3021 treatment effect as determined by a repeated measures analysis of change from baseline in the log-transformed MMTT C-peptide AUC at 12, 16, and 24 weeks
Outcome measures
| Measure |
TOL-3021
n=30 Participants
TOL-3021 2 mg/mL
TOL-3021: TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene.
|
TOL-3021 Placebo
n=13 Participants
TOL-3021 Placebo
TOL-3021 Placebo: TOL-3021 Placebo
|
|---|---|---|
|
Change From Baseline on Log-transformed Mixed Meal Tolerance Test (MMTT) C-peptide Area Under the Curve (AUC)
Week 12
|
-0.04 LOG (pmol/mL/min)
Interval -0.07 to 0.01
|
-0.03 LOG (pmol/mL/min)
Interval -0.07 to 0.02
|
|
Change From Baseline on Log-transformed Mixed Meal Tolerance Test (MMTT) C-peptide Area Under the Curve (AUC)
Week 16
|
-0.02 LOG (pmol/mL/min)
Interval -0.07 to 0.02
|
-0.02 LOG (pmol/mL/min)
Interval -0.08 to 0.04
|
|
Change From Baseline on Log-transformed Mixed Meal Tolerance Test (MMTT) C-peptide Area Under the Curve (AUC)
Week 24
|
-0.06 LOG (pmol/mL/min)
Interval -0.12 to 0.01
|
-0.05 LOG (pmol/mL/min)
Interval -0.13 to 0.03
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1-12, Weeks 13-24Population: An interim analysis was conducted at Week 24 after which the study was terminated and therefore no data is available after Week 24.
Rates of clinically important hypoglycemia events as defined by total measured glucose value of \<54 mg/dL (3.0 mM/L) over each approximately 12-week period ending at Week 24.
Outcome measures
| Measure |
TOL-3021
n=51 Participants
TOL-3021 2 mg/mL
TOL-3021: TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene.
|
TOL-3021 Placebo
n=27 Participants
TOL-3021 Placebo
TOL-3021 Placebo: TOL-3021 Placebo
|
|---|---|---|
|
Hypoglycemia - % Time Continuous Glucose Monitor (CGM) Reading < 54 mg/dL
Weeks 1-12
|
0.2 % Time CGM <54 mg/dL in each period
Interval 0.1 to 0.3
|
0.2 % Time CGM <54 mg/dL in each period
Interval 0.1 to 0.3
|
|
Hypoglycemia - % Time Continuous Glucose Monitor (CGM) Reading < 54 mg/dL
Weeks 13-24
|
0.2 % Time CGM <54 mg/dL in each period
Interval 0.2 to 0.3
|
0.2 % Time CGM <54 mg/dL in each period
Interval 0.1 to 0.3
|
|
Hypoglycemia - % Time Continuous Glucose Monitor (CGM) Reading < 54 mg/dL
Baseline
|
0.3 % Time CGM <54 mg/dL in each period
Interval 0.2 to 0.5
|
0.5 % Time CGM <54 mg/dL in each period
Interval 0.2 to 1.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1-12, Weeks 13-24Population: The study was terminated early after an interim analysis that occurred at Week 24
% Time that CGM measured glucose \<70 mg/dL during each time interval
Outcome measures
| Measure |
TOL-3021
n=50 Participants
TOL-3021 2 mg/mL
TOL-3021: TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene.
|
TOL-3021 Placebo
n=27 Participants
TOL-3021 Placebo
TOL-3021 Placebo: TOL-3021 Placebo
|
|---|---|---|
|
Hypoglycemia -Time CGM < 70 mg/dL
Baseline
|
1.9 % Time CGM < 70 mg/dL
Interval 1.3 to 2.7
|
2.9 % Time CGM < 70 mg/dL
Interval 1.8 to 4.6
|
|
Hypoglycemia -Time CGM < 70 mg/dL
Weeks 1-12
|
1.6 % Time CGM < 70 mg/dL
Interval 1.2 to 2.0
|
1.6 % Time CGM < 70 mg/dL
Interval 1.1 to 2.4
|
|
Hypoglycemia -Time CGM < 70 mg/dL
Weeks 13-24
|
1.5 % Time CGM < 70 mg/dL
Interval 1.2 to 1.9
|
1.4 % Time CGM < 70 mg/dL
Interval 0.9 to 2.1
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1-12, Weeks 13-24Population: ITT efficacy population. Due to early termination of the study, most subjects only had data up to 24 weeks or less.
Number of hypoglycemic events during interval that CGM \< 54 mg/dL for at least 15 consecutive minutes
Outcome measures
| Measure |
TOL-3021
n=51 Participants
TOL-3021 2 mg/mL
TOL-3021: TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene.
|
TOL-3021 Placebo
n=27 Participants
TOL-3021 Placebo
TOL-3021 Placebo: TOL-3021 Placebo
|
|---|---|---|
|
Severe Hypoglycemic Events Lasting at Least 15 Minutes
Baseline
|
5.5 events
Interval 2.9 to 10.6
|
9.3 events
Interval 3.8 to 23.0
|
|
Severe Hypoglycemic Events Lasting at Least 15 Minutes
Weeks 1-12
|
8.2 events
Interval 5.6 to 12.0
|
10.8 events
Interval 6.7 to 17.5
|
|
Severe Hypoglycemic Events Lasting at Least 15 Minutes
Weeks 13-24
|
8.8 events
Interval 6.1 to 12.6
|
15 events
Interval 8.3 to 27.2
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1-12 and Weeks 13-24Population: ITT efficacy population. The study was terminated early after interim analysis showed lack of efficacy.
Change from baseline in mean number of insulin units administered each day
Outcome measures
| Measure |
TOL-3021
n=51 Participants
TOL-3021 2 mg/mL
TOL-3021: TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene.
|
TOL-3021 Placebo
n=27 Participants
TOL-3021 Placebo
TOL-3021 Placebo: TOL-3021 Placebo
|
|---|---|---|
|
Treatment Effect on Daily Insulin Requirements
Weeks 1-12
|
0.6 U/day
Interval -1.4 to 2.6
|
0.6 U/day
Interval -2.2 to 3.5
|
|
Treatment Effect on Daily Insulin Requirements
Weeks 13-24
|
5.1 U/day
Interval 1.2 to 8.9
|
4.1 U/day
Interval -1.0 to 9.3
|
SECONDARY outcome
Timeframe: Baseline, 12, 16, 24 weeksPopulation: Intent to Treat (ITT) efficacy population. The study was terminated after an interim analysis that occurred when \~30 subjects had reached the 24 week time point and therefore no data is available after Week 24.
Change from baseline in Hemoglobin A1c
Outcome measures
| Measure |
TOL-3021
n=51 Participants
TOL-3021 2 mg/mL
TOL-3021: TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene.
|
TOL-3021 Placebo
n=27 Participants
TOL-3021 Placebo
TOL-3021 Placebo: TOL-3021 Placebo
|
|---|---|---|
|
Effect on Hemoglobin A1c (HbA1c)
Week 12
|
0.1 percentage of glycated hemoglobin
Interval -0.1 to 0.3
|
-0.2 percentage of glycated hemoglobin
Interval -0.5 to 0.1
|
|
Effect on Hemoglobin A1c (HbA1c)
Week 16
|
0.0 percentage of glycated hemoglobin
Interval -0.2 to 0.3
|
-0.3 percentage of glycated hemoglobin
Interval -0.7 to 0.1
|
|
Effect on Hemoglobin A1c (HbA1c)
Week 24
|
0.1 percentage of glycated hemoglobin
Interval -0.2 to 0.4
|
-0.3 percentage of glycated hemoglobin
Interval -0.8 to 0.1
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksPopulation: Safety Population. Participants who received at least one dose of TOL-3021 or placebo.
Summary of AEs by MedDRA System Organ Class (SOC) and Preferred Term
Outcome measures
| Measure |
TOL-3021
n=51 Participants
TOL-3021 2 mg/mL
TOL-3021: TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene.
|
TOL-3021 Placebo
n=27 Participants
TOL-3021 Placebo
TOL-3021 Placebo: TOL-3021 Placebo
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any
|
26 # subjects reporting event
|
11 # subjects reporting event
|
|
Number of Participants With Adverse Events (AEs)
Blood & lymphatic system disorders
|
1 # subjects reporting event
|
1 # subjects reporting event
|
|
Number of Participants With Adverse Events (AEs)
Ear & labyrinth disorders
|
0 # subjects reporting event
|
1 # subjects reporting event
|
|
Number of Participants With Adverse Events (AEs)
Endocrine disorders
|
1 # subjects reporting event
|
1 # subjects reporting event
|
|
Number of Participants With Adverse Events (AEs)
Eye disorders
|
1 # subjects reporting event
|
0 # subjects reporting event
|
|
Number of Participants With Adverse Events (AEs)
Gastrointestinal disorders
|
5 # subjects reporting event
|
2 # subjects reporting event
|
|
Number of Participants With Adverse Events (AEs)
General disorders and administration site conditions
|
8 # subjects reporting event
|
3 # subjects reporting event
|
|
Number of Participants With Adverse Events (AEs)
Immune system disorders
|
1 # subjects reporting event
|
1 # subjects reporting event
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksPopulation: Safety population. Subjects receiving at least one dose of TOL-3021 or placebo.
Summary of Related Adverse Events by MedDRA System Organ Class (SOC) and Preferred Term (PT)
Outcome measures
| Measure |
TOL-3021
n=51 Participants
TOL-3021 2 mg/mL
TOL-3021: TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene.
|
TOL-3021 Placebo
n=27 Participants
TOL-3021 Placebo
TOL-3021 Placebo: TOL-3021 Placebo
|
|---|---|---|
|
Summary of Treatment Emergent Adverse Events (TEAEs)
Any
|
3 # subjects reporting event
|
0 # subjects reporting event
|
|
Summary of Treatment Emergent Adverse Events (TEAEs)
General disorders and administration site conditions; injection site hypoaesthesia
|
1 # subjects reporting event
|
0 # subjects reporting event
|
|
Summary of Treatment Emergent Adverse Events (TEAEs)
General disorders and administration site conditions; injection site pain
|
1 # subjects reporting event
|
0 # subjects reporting event
|
|
Summary of Treatment Emergent Adverse Events (TEAEs)
Nervous system disorders; headache
|
1 # subjects reporting event
|
0 # subjects reporting event
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksPopulation: Safety population. Subjects receiving at least one dose of TOL-3021 or placebo.
Summary of AEs by Category of Severity (Mild, Moderate, Severe)
Outcome measures
| Measure |
TOL-3021
n=51 Participants
TOL-3021 2 mg/mL
TOL-3021: TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene.
|
TOL-3021 Placebo
n=27 Participants
TOL-3021 Placebo
TOL-3021 Placebo: TOL-3021 Placebo
|
|---|---|---|
|
Summary of Adverse Events by Severity
All AEs : Mild
|
16 number of events
|
8 number of events
|
|
Summary of Adverse Events by Severity
All AEs : Moderate
|
12 number of events
|
5 number of events
|
|
Summary of Adverse Events by Severity
All AEs : Severe
|
0 number of events
|
0 number of events
|
|
Summary of Adverse Events by Severity
All TEAEs : Mild
|
12 number of events
|
8 number of events
|
|
Summary of Adverse Events by Severity
All TEAEs : Moderate
|
11 number of events
|
5 number of events
|
|
Summary of Adverse Events by Severity
All TEAEs : Severe
|
0 number of events
|
1 number of events
|
|
Summary of Adverse Events by Severity
All Related AEs : Mild
|
1 number of events
|
0 number of events
|
|
Summary of Adverse Events by Severity
All Related AEs : Moderate
|
0 number of events
|
0 number of events
|
|
Summary of Adverse Events by Severity
All Related AEs : Severe
|
0 number of events
|
0 number of events
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksPopulation: Safety population. Subjects receiving at least one dose of TOL-3021 or placebo.
Summary of Serious Adverse Events (SAEs) and Deaths
Outcome measures
| Measure |
TOL-3021
n=51 Participants
TOL-3021 2 mg/mL
TOL-3021: TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene.
|
TOL-3021 Placebo
n=27 Participants
TOL-3021 Placebo
TOL-3021 Placebo: TOL-3021 Placebo
|
|---|---|---|
|
Serious Adverse Events (SAEs) and Deaths
All SAEs
|
0 # subjects reporting event
|
0 # subjects reporting event
|
|
Serious Adverse Events (SAEs) and Deaths
All Deaths
|
0 # subjects reporting event
|
0 # subjects reporting event
|
Adverse Events
TOL-3021
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
TOL-3021 Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TOL-3021
n=51 participants at risk
TOL-3021 2 mg/mL
TOL-3021: TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene.
|
TOL-3021 Placebo
n=27 participants at risk
TOL-3021 Placebo
TOL-3021 Placebo: TOL-3021 Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Blood and lymphatic system disorders
Thymus enlargement
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Ear and labyrinth disorders
Ear Discomfort
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Endocrine disorders
Addison's disease
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Endocrine disorders
Thyroid Mass
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Eye disorders
Vision blurred
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 2 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Gastrointestinal disorders
Toothache
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
3/51 • Number of events 3 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 2 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
General disorders
Application site irritation
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
General disorders
Fatigue
|
3.9%
2/51 • Number of events 3 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
7.4%
2/27 • Number of events 2 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
General disorders
Influenza like illness
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
General disorders
Injection site haemorrhage
|
5.9%
3/51 • Number of events 4 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
General disorders
Injection site hypoaesthesia
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
General disorders
Injection site pain
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
General disorders
Pain
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Immune system disorders
Seasonal allergy
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Infections and infestations
COVID-19
|
3.9%
2/51 • Number of events 2 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Infections and infestations
Ear infection
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Infections and infestations
Fungal infection
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Infections and infestations
Implant site cellulitis
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Infections and infestations
Influenza
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Infections and infestations
Mastitis
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 2 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Infections and infestations
Oral herpes
|
3.9%
2/51 • Number of events 2 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Infections and infestations
Pharyngitis streptococcal
|
3.9%
2/51 • Number of events 2 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Infections and infestations
Rhinitis
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Infections and infestations
Rhinovirus infection
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Infections and infestations
Urinary tract infection
|
3.9%
2/51 • Number of events 2 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Injury, poisoning and procedural complications
Exposure to communicable disease
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
7.4%
2/27 • Number of events 2 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue mass
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Nervous system disorders
Headache
|
9.8%
5/51 • Number of events 5 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
7.4%
2/27 • Number of events 2 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Nervous system disorders
Migraine
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Nervous system disorders
Paraesthesia
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Psychiatric disorders
Alcohol use disorder
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Psychiatric disorders
Anxiety
|
3.9%
2/51 • Number of events 2 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Psychiatric disorders
Bipolar disorder
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Psychiatric disorders
Depression
|
3.9%
2/51 • Number of events 2 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Psychiatric disorders
Initial insomnia
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/51 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Skin and subcutaneous tissue disorders
Mechanical urticaria
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/51 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.9%
2/51 • Number of events 2 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
3.7%
1/27 • Number of events 1 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.0%
1/51 • Number of events 2 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
0.00%
0/27 • Adverse Events were planned to be collected from the time of signing informed consent up to a maximum of 52 weeks post treatment. However, an interim analysis was conducted after 28 subjects had completed week 24 (19 TOL-3021 and 9 placebo subjects) and the study was terminated due to lack of efficacy.
|
Additional Information
David Glover, Director of Research and Development
PBM Capital Group
Phone: (434) 980-8154
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place