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Change in the clinical development plan
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A Randomized, Double Blind, Placebo-Controlled study to assess the Safety, Local Tolerance, and Pharmacokinetics of LT5001 drug product in Hemodialysis Patients with Uremic Pruritus
In Part A, patient participation is expected to last up to 63 days, including a 28-day screening period(consisting of a 7-day diary run-in to build baseline itch NRS) and a 36-day on study period (consisting of 56 total doses from Day 1 to Day 29, and a 7 day follow-up/EOS visit at Day 36).
In Part B, patient participation is expected to last up to 85 days, including a 28-day screening period (consisting of a 7-day diary run-in to build baseline itch NRS) and a 57-day on study treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LT5001 | Active Comparator | Administered twice daily (maximum 6 g per time, morning and evening respectively) |
|
| Placebo | Placebo Comparator | Administered twice daily (maximum 6 g per time, morning and evening respectively) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LT5001 | Drug | LT5001 is administered twice daily. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Events With AE by Severity | The number of reported AE events by severity | Week 4 |
| Number of Patients With AE by Severity | Adverse events (AEs) were collected and categorized by severity (mild, moderate, or severe) according to standard clinical criteria. The outcome measure is defined as the number of patients who experienced at least one adverse event of each severity level during the study period. | Week 4 |
| The Number of Patients With AE by Causality | Adverse events were assessed for their causal relationship to the study treatment by the investigator and categorized as related or not related. The outcome measure is defined as the number of patients who experienced at least one adverse event in each causality category during the study period. | 4 weeks |
| Number of AE Event by Causality | The number of reported events by causality | week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic Ctrough Exposure of LT5001 in Hemodialysis Patients. | The systemic trough (Ctrough) concentration of LT5001 was measured in hemodialysis patients at specified time points prior to the next scheduled dose using validated bioanalytical methods. The outcome measure is defined as the plasma concentration of LT5001 immediately before each dosing interval. | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| June Kuo | Lumosa Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Taichung | Taiwan |
Participants underwent a 7-day run-in period prior to Part A. Only participants meeting eligibility criteria after the run-in period were enrolled into Part A. No participants entered Part B, as Part B was not initiated.
The study was terminated after completion of Part A (18 participants). Part B was planned but not initiated.
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| ID | Title | Description |
|---|---|---|
| FG000 | LT5001 | LT5001 group |
| FG001 | Placebo | Placebo as control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A |
| |||||||||||||
| Part B (Not Initiated) |
|
12 participant in the LT5001 group; 6 in the placebo group
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| ID | Title | Description |
|---|---|---|
| BG000 | LT5001 | Administered twice daily |
| BG001 | Placebo | Administered twice daily |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Events With AE by Severity | The number of reported AE events by severity | Safety population: include all patients who receive at least 1 dose of LT5001 drug product or placebo | Posted | Number | events | Week 4 |
|
from enrollment until end of follow-up, up to 5 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LT5001 | Administered twice daily (maximum 6 g per time, morning and evening respectively) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vitreous haemorrhage | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Claire Sun | Lumosa Therapeutics | +886-2-2655-7918 | 5737 | claire_sun@lumosa.com.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 4, 2020 | Dec 30, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 13, 2020 | Dec 30, 2025 | SAP_001.pdf |
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| Drug |
LT5001 is administered twice daily. |
|
| Change in Mean Worst Itching Intensity From Baseline to the End of Week 4 Using NRS. | The intensity of itch will be measured using the Numerical Rating Scale (NRS), a standardized scale for assessing the worst itching over the past 24 hours. The scale ranges from 0 to 10, where 0 represents no itching and 10 represents the worst itching imaginable. Higher scores indicate worse itch severity. The outcome measure is defined as the change in mean worst itching intensity from baseline to the end of Week 4. | Week 4 |
| Proportion of Patients With Changes in Numerical Rating Scale (>=2 Points, >=3 Points, >=4 Points) From Baseline | The Numerical Rating Scale (NRS) is an 11-point scale used to assess itch intensity, where scores range from 0 to 10, with 0 indicating no pain and 10 indicating the worst itch imaginable. A decrease in NRS score represents an improvement in itch severity. This outcome measures the proportion of patients who achieved a reduction of at least 2 points, 3 points, or 4 points from baseline in NRS score at Week 4. | Week 4 |
| Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in 5-D Pruritus Scale at the End of Week 4. | The 5-D Pruritus Scale (5-D Itch Scale) is a multidimensional questionnaire assessing itching across five key domains: Duration, Degree, Direction, Disability, and Distribution, to comprehensively evaluate the impact of itch on daily life. The scale ranges from 5 to 25, with 5 representing no itch and 25 representing severe itch. Each domain is scored from 1 (lowest) to 5 (highest). Higher scores indicate worse itch and poorer itch-related quality of life, whereas lower scores indicate better quality of life. The outcome measure is defined as the change from baseline in 5-D Pruritus Scale total score at the end of Week 4, with improvement reflected by a decrease in total score. | Week 4 |
| Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in Total Skindex-10 Scale Score at the End of Week 4. | The Skindex-10 Scale is a multidimensional questionnaire assessing itch-related quality of life over the past week. The questions cover 3 domains: disease, mood/emotional distress, and social functioning domain. Each of the 10 items is scored from 0 to 6, resulting in a total score ranging from 0 to 60, where 0 represents never bothered/no impact and 60 represents always bothered/severe impact. Higher scores indicate worst itch-related quality of life, whereas lower scores indicate better quality of life. The outcome measure is defined as the change from baseline in total Skindex-10 Scale Score at the end of Week 4, with improvement reflected by a decrease in total score. | Week 4 |
| NOT COMPLETED |
|
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| weight | Mean | Standard Deviation | kilogram |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Number of Patients With AE by Severity | Adverse events (AEs) were collected and categorized by severity (mild, moderate, or severe) according to standard clinical criteria. The outcome measure is defined as the number of patients who experienced at least one adverse event of each severity level during the study period. | include all patients who receive at least 1 dose of LT5001 drug product or placebo | Posted | Count of Participants | Participants | Week 4 |
|
|
|
| Primary | The Number of Patients With AE by Causality | Adverse events were assessed for their causal relationship to the study treatment by the investigator and categorized as related or not related. The outcome measure is defined as the number of patients who experienced at least one adverse event in each causality category during the study period. | Include all patients who receive at least 1 dose of LT5001 drug product or placebo | Posted | Number | participants | 4 weeks |
|
|
|
| Primary | Number of AE Event by Causality | The number of reported events by causality | include all patients who receive at least 1 dose of LT5001 drug product or placebo | Posted | Number | events | week 4 |
|
|
|
| Secondary | Systemic Ctrough Exposure of LT5001 in Hemodialysis Patients. | The systemic trough (Ctrough) concentration of LT5001 was measured in hemodialysis patients at specified time points prior to the next scheduled dose using validated bioanalytical methods. The outcome measure is defined as the plasma concentration of LT5001 immediately before each dosing interval. | include patients who have received at least 1 dose of LT5001 drug product and have at least 1 measured concentration of LT5001 drug product at a scheduled PK time point after dosing. | Posted | Mean | Standard Deviation | ng/ml of LT5001 in blood | Week 4 |
|
|
|
| Secondary | Change in Mean Worst Itching Intensity From Baseline to the End of Week 4 Using NRS. | The intensity of itch will be measured using the Numerical Rating Scale (NRS), a standardized scale for assessing the worst itching over the past 24 hours. The scale ranges from 0 to 10, where 0 represents no itching and 10 represents the worst itching imaginable. Higher scores indicate worse itch severity. The outcome measure is defined as the change in mean worst itching intensity from baseline to the end of Week 4. | include all randomized patients who received at least 1 dose of LT5001 drug product or placebo | Posted | Mean | Standard Deviation | score on the Numerical Rating Scale (NRS | Week 4 |
|
|
|
| Secondary | Proportion of Patients With Changes in Numerical Rating Scale (>=2 Points, >=3 Points, >=4 Points) From Baseline | The Numerical Rating Scale (NRS) is an 11-point scale used to assess itch intensity, where scores range from 0 to 10, with 0 indicating no pain and 10 indicating the worst itch imaginable. A decrease in NRS score represents an improvement in itch severity. This outcome measures the proportion of patients who achieved a reduction of at least 2 points, 3 points, or 4 points from baseline in NRS score at Week 4. | include all randomized patients who received at least 1 dose of LT5001 drug product or placebo | Posted | Number | participants | Week 4 |
|
|
|
| Secondary | Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in 5-D Pruritus Scale at the End of Week 4. | The 5-D Pruritus Scale (5-D Itch Scale) is a multidimensional questionnaire assessing itching across five key domains: Duration, Degree, Direction, Disability, and Distribution, to comprehensively evaluate the impact of itch on daily life. The scale ranges from 5 to 25, with 5 representing no itch and 25 representing severe itch. Each domain is scored from 1 (lowest) to 5 (highest). Higher scores indicate worse itch and poorer itch-related quality of life, whereas lower scores indicate better quality of life. The outcome measure is defined as the change from baseline in 5-D Pruritus Scale total score at the end of Week 4, with improvement reflected by a decrease in total score. | include all randomized patients who received at least 1 dose of LT5001 drug product or placebo. | Posted | Mean | Standard Deviation | score on a scale | Week 4 |
|
|
|
| Secondary | Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in Total Skindex-10 Scale Score at the End of Week 4. | The Skindex-10 Scale is a multidimensional questionnaire assessing itch-related quality of life over the past week. The questions cover 3 domains: disease, mood/emotional distress, and social functioning domain. Each of the 10 items is scored from 0 to 6, resulting in a total score ranging from 0 to 60, where 0 represents never bothered/no impact and 60 represents always bothered/severe impact. Higher scores indicate worst itch-related quality of life, whereas lower scores indicate better quality of life. The outcome measure is defined as the change from baseline in total Skindex-10 Scale Score at the end of Week 4, with improvement reflected by a decrease in total score. | include all randomized patients who received at least 1 dose of LT5001 drug product or placebo. | Posted | Mean | Standard Deviation | score on a scale | Week 4 |
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| 7 |
| 12 |
| EG001 | Placebo | Administered twice daily (maximum 6 g per time, morning and evening respectively) | 0 | 6 | 0 | 6 | 2 | 6 |
| Angina pectoris | Cardiac disorders | Systematic Assessment |
|
| Toxic goitre | Endocrine disorders | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
|
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| Severe |
|
| Possibly |
|
| Probably |
|
| Definitely |
|
| possibly |
|
| probably |
|
| definitely |
|
| >= 4 points |
|