NCT04393675

Study to Investigate the Safety of LT5001 Drug Product for Uremic Pruritus in Hemodialysis Patients

Terminated Phase 1, PHASE2 Results posted Last updated 10 February 2026

What this trial tests

Phase 1, PHASE2 trial testing LT5001 in Uremic Pruritus in 18 participants. Terminated before completion.

Timeline

14 May 2020

Primary endpoint
15 September 2022

15 September 2022

Quick facts

Lead sponsor	Lumosa Therapeutics Co., Ltd.
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	18
Start date	14 May 2020
Primary completion	15 September 2022
Estimated completion	15 September 2022
Sites	1 location across Taiwan

Drugs / interventions tested

• LT5001 — full drug profile →
• Placebo

Conditions studied

• Uremic Pruritus — all drugs for Uremic Pruritus →

Sponsor

Lumosa Therapeutics Co., Ltd. — full company profile →

Who can join

Adults 20 to 75, any sex, with Uremic Pruritus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Events With AE by Severity Primary · Week 4

The number of reported AE events by severity

Any TEAE by severity -Mild

Group	Value	95% CI
LT5001	6
Placebo	2

Any TEAE by severity -Moderate

Group	Value	95% CI
LT5001	0
Placebo	0

Any TEAE by severity -Severe

Group	Value	95% CI
LT5001	1
Placebo	0

Number of Patients With AE by Severity Primary · Week 4

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.

Mild

Group	Value	95% CI
LT5001	6
Placebo	1

Moderate

Group	Value	95% CI
LT5001	0
Placebo	0

Severe

Group	Value	95% CI
LT5001	1
Placebo	0

The Number of Patients With AE by Causality Primary · 4 weeks

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.

unrelated

Group	Value	95% CI
LT5001	5
Placebo	1

unlikely

Group	Value	95% CI
LT5001	0
Placebo	0

Possibly

Group	Value	95% CI
LT5001	1
Placebo	0

Probably

Group	Value	95% CI
LT5001	0
Placebo	0

Definitely

Group	Value	95% CI
LT5001	0
Placebo	0

Number of AE Event by Causality Primary · week 4

The number of reported events by causality

unrelated

Group	Value	95% CI
LT5001	6
Placebo	2

unlikely

Group	Value	95% CI
LT5001	0
Placebo	0

possibly

Group	Value	95% CI
LT5001	1
Placebo	0

probably

Group	Value	95% CI
LT5001	0
Placebo	0

definitely

Group	Value	95% CI
LT5001	0
Placebo	0

Systemic Ctrough Exposure of LT5001 in Hemodialysis Patients. Secondary · Week 4

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.

Group	Value	95% CI
LT5001	NA	± NA
Placebo	NA	± NA

Change in Mean Worst Itching Intensity From Baseline to the End of Week 4 Using NRS. Secondary · Week 4

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.

Group	Value	95% CI
LT5001	-1.8	± 2.1
Placebo	-2.3	± 2.4

Proportion of Patients With Changes in Numerical Rating Scale (>=2 Points, >=3 Points, >=4 Points) From Baseline Secondary · Week 4

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.

>=2 points >=2 points >=2 points >=2 points >= 2 points

Group	Value	95% CI
LT5001	5
Placebo	3

>= 3 points

Group	Value	95% CI
LT5001	2
Placebo	2

>= 4 points

Group	Value	95% CI
LT5001	1
Placebo	2

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. Secondary · 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 tota

Group	Value	95% CI
LT5001	-3.2	± 2.9
Placebo	-3.8	± 1.6

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. Secondary · 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 Scor

Group	Value	95% CI
LT5001	-15.1	± 11.2
Placebo	-22.2	± 3.6

Adverse events — posted to ClinicalTrials.gov

Time frame: from enrollment until end of follow-up, up to 5 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

LT5001

Serious: 1/12 (8%)

Deaths: 0/12

Placebo

Serious: 0/6 (0%)

Deaths: 0/6

Serious adverse events (1 terms)

Reaction	System	LT5001	Placebo
vitreous haemorrhage	Eye disorders	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	LT5001	Placebo
Contusion	Injury, poisoning and procedural complications	—	—
skin rash	Skin and subcutaneous tissue disorders	—	—
Angina pectoris	Cardiac disorders	—	—
Toxic goitre	Endocrine disorders	—	—
Vitreous haemorrhage	Eye disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Hypoaesthesia	Nervous system disorders	—	—

Most-reported serious reactions: vitreous haemorrhage.

Data from ClinicalTrials.gov NCT04393675 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.