Trial Outcomes & Findings for The Efficacy and Safety of TLL018 in Moderate-to-severe Plaque Psoriasis (NCT NCT05772520)
NCT ID: NCT05772520
Last Updated: 2026-07-21
Results Overview
A PASI 75 response is defined as achieving at least a 75% improvement (reduction) in the Psoriasis Area and Severity Index (PASI) score from baseline. The PASI is a composite tool that assesses the overall severity of erythema, induration, and scaling, as well as the extent of body surface area involvement. The total PASI score ranges from 0 to 72, with higher scores indicating more severe disease. The results are in Full Analysis Set (FAS).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
82 participants
Primary outcome timeframe
Week12
Results posted on
2026-07-21
Participant Flow
Participant milestones
| Measure |
Cohort 1
TLL018 tables, 40 mg, BID TLL018 tablets: oral tablets administered for 12 weeks
|
Cohort 2
TLL018 tables, 20 mg, BID
TLL018 tablets: oral tablets administered for 12 weeks
|
Cohort 3
TLL018: 10 mg BID (per protocol V 1.0)
TLL018 tablets: oral tablets administered for 12 weeks
|
Cohort 4
Placebo BID
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
8
|
14
|
|
Overall Study
COMPLETED
|
24
|
23
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Not applicable. All participants are included.
Baseline characteristics by cohort
| Measure |
Cohort 1
n=31 Participants
TLL018 tables, 40 mg, BID TLL018 tablets: oral tablets administered for 12 weeks
|
Cohort 2
n=29 Participants
TLL018 tables, 20 mg, BID
TLL018 tablets: oral tablets administered for 12 weeks
|
Cohort 3
n=8 Participants
TLL018: 10 mg BID (per protocol V 1.0)
TLL018 tablets: oral tablets administered for 12 weeks
|
Cohort 4
n=14 Participants
Placebo BID
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
13 Participants
n=9 Participants • Not applicable. All participants are included.
|
7 Participants
n=27 Participants • Not applicable. All participants are included.
|
1 Participants
n=267 Participants • Not applicable. All participants are included.
|
7 Participants
n=265 Participants • Not applicable. All participants are included.
|
28 Participants
n=568 Participants • Not applicable. All participants are included.
|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 14.0 • n=9 Participants • Not applicable. All participants are included.
|
47.1 years
STANDARD_DEVIATION 14.8 • n=27 Participants • Not applicable. All participants are included.
|
49.3 years
STANDARD_DEVIATION 10.7 • n=267 Participants • Not applicable. All participants are included.
|
43.9 years
STANDARD_DEVIATION 14.6 • n=265 Participants • Not applicable. All participants are included.
|
47.1 years
STANDARD_DEVIATION 13.9 • n=568 Participants • Not applicable. All participants are included.
|
|
Sex: Female, Male
Male
|
18 Participants
n=9 Participants • Not applicable. All participants are included.
|
22 Participants
n=27 Participants • Not applicable. All participants are included.
|
7 Participants
n=267 Participants • Not applicable. All participants are included.
|
7 Participants
n=265 Participants • Not applicable. All participants are included.
|
54 Participants
n=568 Participants • Not applicable. All participants are included.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=9 Participants • Not applicable. All participants are included.
|
1 Participants
n=27 Participants • Not applicable. All participants are included.
|
0 Participants
n=267 Participants • Not applicable. All participants are included.
|
0 Participants
n=265 Participants • Not applicable. All participants are included.
|
3 Participants
n=568 Participants • Not applicable. All participants are included.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants • Not applicable. All participants are included.
|
2 Participants
n=27 Participants • Not applicable. All participants are included.
|
2 Participants
n=267 Participants • Not applicable. All participants are included.
|
2 Participants
n=265 Participants • Not applicable. All participants are included.
|
7 Participants
n=568 Participants • Not applicable. All participants are included.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=9 Participants • Not applicable. All participants are included.
|
0 Participants
n=27 Participants • Not applicable. All participants are included.
|
0 Participants
n=267 Participants • Not applicable. All participants are included.
|
0 Participants
n=265 Participants • Not applicable. All participants are included.
|
1 Participants
n=568 Participants • Not applicable. All participants are included.
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=9 Participants • Not applicable. All participants are included.
|
2 Participants
n=27 Participants • Not applicable. All participants are included.
|
0 Participants
n=267 Participants • Not applicable. All participants are included.
|
1 Participants
n=265 Participants • Not applicable. All participants are included.
|
6 Participants
n=568 Participants • Not applicable. All participants are included.
|
|
Race (NIH/OMB)
White
|
23 Participants
n=9 Participants • Not applicable. All participants are included.
|
24 Participants
n=27 Participants • Not applicable. All participants are included.
|
6 Participants
n=267 Participants • Not applicable. All participants are included.
|
11 Participants
n=265 Participants • Not applicable. All participants are included.
|
64 Participants
n=568 Participants • Not applicable. All participants are included.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants • Not applicable. All participants are included.
|
0 Participants
n=27 Participants • Not applicable. All participants are included.
|
0 Participants
n=267 Participants • Not applicable. All participants are included.
|
0 Participants
n=265 Participants • Not applicable. All participants are included.
|
0 Participants
n=568 Participants • Not applicable. All participants are included.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants • Not applicable. All participants are included.
|
0 Participants
n=27 Participants • Not applicable. All participants are included.
|
0 Participants
n=267 Participants • Not applicable. All participants are included.
|
0 Participants
n=265 Participants • Not applicable. All participants are included.
|
1 Participants
n=568 Participants • Not applicable. All participants are included.
|
|
Body Surface Area
|
27.42 Percentage of BSA
STANDARD_DEVIATION 15.53 • n=9 Participants • Not applicable. All participants are included.
|
22.01 Percentage of BSA
STANDARD_DEVIATION 13.09 • n=27 Participants • Not applicable. All participants are included.
|
21.38 Percentage of BSA
STANDARD_DEVIATION 12.43 • n=267 Participants • Not applicable. All participants are included.
|
28.11 Percentage of BSA
STANDARD_DEVIATION 14.37 • n=265 Participants • Not applicable. All participants are included.
|
25.03 Percentage of BSA
STANDARD_DEVIATION 14.26 • n=568 Participants • Not applicable. All participants are included.
|
|
PASI score
|
19.40 units on a scale
STANDARD_DEVIATION 8.01 • n=9 Participants • Not applicable. All participants are included.
|
16.47 units on a scale
STANDARD_DEVIATION 5.69 • n=27 Participants • Not applicable. All participants are included.
|
17.36 units on a scale
STANDARD_DEVIATION 7.21 • n=267 Participants • Not applicable. All participants are included.
|
20.11 units on a scale
STANDARD_DEVIATION 6.80 • n=265 Participants • Not applicable. All participants are included.
|
18.29 units on a scale
STANDARD_DEVIATION 7.02 • n=568 Participants • Not applicable. All participants are included.
|
|
PGA score category
Score 3 (Moderate)
|
16 Participants
n=9 Participants • The Physician Global Assessment (PGA) is a clinical scale used to evaluate overall disease severity. The score ranges from 0 to 4, where 0 indicates clear/no disease and 4 indicates severe disease. Data are presented as the number of participants in each score category.
|
19 Participants
n=27 Participants • The Physician Global Assessment (PGA) is a clinical scale used to evaluate overall disease severity. The score ranges from 0 to 4, where 0 indicates clear/no disease and 4 indicates severe disease. Data are presented as the number of participants in each score category.
|
7 Participants
n=267 Participants • The Physician Global Assessment (PGA) is a clinical scale used to evaluate overall disease severity. The score ranges from 0 to 4, where 0 indicates clear/no disease and 4 indicates severe disease. Data are presented as the number of participants in each score category.
|
8 Participants
n=265 Participants • The Physician Global Assessment (PGA) is a clinical scale used to evaluate overall disease severity. The score ranges from 0 to 4, where 0 indicates clear/no disease and 4 indicates severe disease. Data are presented as the number of participants in each score category.
|
50 Participants
n=568 Participants • The Physician Global Assessment (PGA) is a clinical scale used to evaluate overall disease severity. The score ranges from 0 to 4, where 0 indicates clear/no disease and 4 indicates severe disease. Data are presented as the number of participants in each score category.
|
|
PGA score category
Score 4 (Severe)
|
15 Participants
n=9 Participants • The Physician Global Assessment (PGA) is a clinical scale used to evaluate overall disease severity. The score ranges from 0 to 4, where 0 indicates clear/no disease and 4 indicates severe disease. Data are presented as the number of participants in each score category.
|
10 Participants
n=27 Participants • The Physician Global Assessment (PGA) is a clinical scale used to evaluate overall disease severity. The score ranges from 0 to 4, where 0 indicates clear/no disease and 4 indicates severe disease. Data are presented as the number of participants in each score category.
|
1 Participants
n=267 Participants • The Physician Global Assessment (PGA) is a clinical scale used to evaluate overall disease severity. The score ranges from 0 to 4, where 0 indicates clear/no disease and 4 indicates severe disease. Data are presented as the number of participants in each score category.
|
6 Participants
n=265 Participants • The Physician Global Assessment (PGA) is a clinical scale used to evaluate overall disease severity. The score ranges from 0 to 4, where 0 indicates clear/no disease and 4 indicates severe disease. Data are presented as the number of participants in each score category.
|
32 Participants
n=568 Participants • The Physician Global Assessment (PGA) is a clinical scale used to evaluate overall disease severity. The score ranges from 0 to 4, where 0 indicates clear/no disease and 4 indicates severe disease. Data are presented as the number of participants in each score category.
|
PRIMARY outcome
Timeframe: Week12Population: Full Analysis Set (FAS), as pre-specified in the Statistical Analysis Plan (SAP). The FAS includes all randomized participants who received at least one dose of the study drug. Missing data were handled using Non-Responder Imputation.
A PASI 75 response is defined as achieving at least a 75% improvement (reduction) in the Psoriasis Area and Severity Index (PASI) score from baseline. The PASI is a composite tool that assesses the overall severity of erythema, induration, and scaling, as well as the extent of body surface area involvement. The total PASI score ranges from 0 to 72, with higher scores indicating more severe disease. The results are in Full Analysis Set (FAS).
Outcome measures
| Measure |
Cohort 1
n=31 Participants
TLL018 tables, 40 mg, BID TLL018 tablets: oral tablets administered for 12 weeks
|
Cohort 2
n=29 Participants
TLL018 tables, 20 mg, BID
TLL018 tablets: oral tablets administered for 12 weeks
|
Cohort 3
n=8 Participants
TLL018: 10 mg BID (per protocol V 1.0)
TLL018 tablets: oral tablets administered for 12 weeks
|
Cohort 4
n=14 Participants
Placebo BID
|
|---|---|---|---|---|
|
Proportion of Participants Achieving PASI-75 (FAS)
|
11 Participants
|
13 Participants
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Week12Population: The per-protocol set (PPS), as pre-specified in the Statistical Analysis Plan (SAP). PPS will include a subset of FAS. Participants who meet the major protocol deviations will not be included into PPS. Per-protocol set will be used for primary efficacy endpoint as a sensitivity analysis.
A PASI 75 response is defined as achieving at least a 75% improvement (reduction) in the Psoriasis Area and Severity Index (PASI) score from baseline. The PASI is a composite tool that assesses the overall severity of erythema, induration, and scaling, as well as the extent of body surface area involvement. The total PASI score ranges from 0 to 72, with higher scores indicating more severe disease. The results are in Per-Protocol Set. Excludes participants with major protocol violations.
Outcome measures
| Measure |
Cohort 1
n=18 Participants
TLL018 tables, 40 mg, BID TLL018 tablets: oral tablets administered for 12 weeks
|
Cohort 2
n=18 Participants
TLL018 tables, 20 mg, BID
TLL018 tablets: oral tablets administered for 12 weeks
|
Cohort 3
n=8 Participants
TLL018: 10 mg BID (per protocol V 1.0)
TLL018 tablets: oral tablets administered for 12 weeks
|
Cohort 4
n=8 Participants
Placebo BID
|
|---|---|---|---|---|
|
Proportion of Participants Achieving PASI 75 (PPS)
|
9 Participants
|
11 Participants
|
4 Participants
|
2 Participants
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4
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 |
Cohort 1
n=31 participants at risk
TLL018 tables, 40 mg, BID TLL018 tablets: oral tablets administered for 12 weeks
|
Cohort 2
n=29 participants at risk
TLL018 tables, 20 mg, BID
TLL018 tablets: oral tablets administered for 12 weeks
|
Cohort 3
n=8 participants at risk
TLL018: 10 mg BID (per protocol V 1.0)
TLL018 tablets: oral tablets administered for 12 weeks
|
Cohort 4
n=14 participants at risk
Placebo BID
|
|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
6.5%
2/31 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
10.3%
3/29 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/8 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
7.1%
1/14 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
|
Investigations
Aspartate aminotransferase increased
|
3.2%
1/31 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
6.9%
2/29 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/8 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/14 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
1/31 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/29 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
12.5%
1/8 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/14 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.5%
2/31 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
6.9%
2/29 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/8 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/14 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.5%
2/31 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/29 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/8 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/14 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
|
Nervous system disorders
Headache
|
6.5%
2/31 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
3.4%
1/29 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/8 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/14 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
|
Investigations
Blood pressure increased
|
3.2%
1/31 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/29 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/8 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
7.1%
1/14 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/31 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
3.4%
1/29 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/8 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
7.1%
1/14 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/31 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/29 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/8 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
7.1%
1/14 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
|
Infections and infestations
Influenza
|
3.2%
1/31 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
3.4%
1/29 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/8 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
7.1%
1/14 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
|
Infections and infestations
Urinary tract infection
|
3.2%
1/31 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/29 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/8 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
7.1%
1/14 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
|
Infections and infestations
Viral infection
|
0.00%
0/31 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/29 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/8 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
7.1%
1/14 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
|
Nervous system disorders
Migraine
|
0.00%
0/31 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/29 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/8 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
7.1%
1/14 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/31 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/29 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/8 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
7.1%
1/14 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
1/31 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/29 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/8 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
7.1%
1/14 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
|
Eye disorders
Eyelid myokymia
|
0.00%
0/31 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/29 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
0.00%
0/8 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
7.1%
1/14 • AEs were collected from informed consent up to 4 weeks after the last dose of study drug (up to a total of 16 weeks). Displays of treatment-emergent AEs (TEAEs) are provided using the Safety population.
Adverse events (AEs) were evaluated in the Safety Population, defined as all participants who received at least one dose of the study medication. AEs were monitored at each study visit and coded using the Medical Dictionary for Regulatory Activities (MedDRA).Definitions align with ClinicalTrials.gov standards.
|
Additional Information
Chris Liang CEO of Highlightll Pharmaceutical (USA) LLC
Highlightll Pharmaceutical (USA) LLC
Phone: 1-561-283-6657
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place