Trial Outcomes & Findings for Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus (NCT NCT04256759)
NCT ID: NCT04256759
Last Updated: 2025-11-21
Results Overview
Pruritus severity is measured using the peak PNRS assessed as a single, self-completed item that assesses the intensity of peak (worst) pruritus during the past 24 hours using the query: "On a scale of 0 to 10, with 0 being 'no itch 'and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Measured before and after treatment. Scores range from 0 to 10 with higher scores indicating a worse outcome.
COMPLETED
PHASE2
9 participants
Baseline; 20 weeks
2025-11-21
Participant Flow
Participant milestones
| Measure |
Dupilumab
Subcutaneous (SC) dupilumab selected for this study was 300 mg every 2 weeks for 18 weeks.
Dupilumab 300Mg Solution for Injection: Subcutaneous (SC) dupilumab selected for this study was 300 mg every 2 weeks for 18 weeks.
|
|---|---|
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Overall Study
STARTED
|
9
|
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Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Dupilumab
Subcutaneous (SC) dupilumab selected for this study was 300 mg every 2 weeks for 18 weeks.
Dupilumab 300Mg Solution for Injection: Subcutaneous (SC) dupilumab selected for this study was 300 mg every 2 weeks for 18 weeks.
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|---|---|
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Overall Study
Physician Decision
|
1
|
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Overall Study
Lack of Efficacy
|
1
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Baseline Characteristics
Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus
Baseline characteristics by cohort
| Measure |
Dupilumab
n=9 Participants
Subcutaneous (SC) dupilumab selected for this study was 300 mg every 2 weeks for 18 weeks.
Dupilumab 300Mg Solution for Injection: Subcutaneous (SC) dupilumab selected for this study was 300 mg every 2 weeks for 18 weeks.
|
|---|---|
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Age, Continuous
|
56.2 years
STANDARD_DEVIATION 14.3 • n=39 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
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Sex: Female, Male
Male
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3 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Baseline; 20 weeksPruritus severity is measured using the peak PNRS assessed as a single, self-completed item that assesses the intensity of peak (worst) pruritus during the past 24 hours using the query: "On a scale of 0 to 10, with 0 being 'no itch 'and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Measured before and after treatment. Scores range from 0 to 10 with higher scores indicating a worse outcome.
Outcome measures
| Measure |
Dupilumab
n=9 Participants
Subcutaneous (SC) dupilumab selected for this study was 300 mg every 2 weeks for 18 weeks.
Dupilumab 300Mg Solution for Injection: Subcutaneous (SC) dupilumab selected for this study was 300 mg every 2 weeks for 18 weeks.
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|---|---|
|
Change in Peak Pruritus Numerical Rating Score (PRNS)
|
-3.1 score on a scale
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Baseline; week 6,12,18Pruritus severity is measured using the peak PNRS assessed as a single, self-completed item that assesses the intensity of peak (worst) pruritus during the past 24 hours using the query: "On a scale of 0 to 10, with 0 being 'no itch 'and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Scores range from 0 to 10 with higher scores indicating a worse outcome.
Outcome measures
| Measure |
Dupilumab
n=9 Participants
Subcutaneous (SC) dupilumab selected for this study was 300 mg every 2 weeks for 18 weeks.
Dupilumab 300Mg Solution for Injection: Subcutaneous (SC) dupilumab selected for this study was 300 mg every 2 weeks for 18 weeks.
|
|---|---|
|
Change in Weekly Average Peak Pruritus Numerical Rating Score (PRNS) ≥3 From Baseline
Week 6
|
-3.2 score on a scale
Standard Deviation 3.6
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|
Change in Weekly Average Peak Pruritus Numerical Rating Score (PRNS) ≥3 From Baseline
Week 12
|
-3.5 score on a scale
Standard Deviation 3.9
|
|
Change in Weekly Average Peak Pruritus Numerical Rating Score (PRNS) ≥3 From Baseline
Week 18
|
-4.1 score on a scale
Standard Deviation 4.4
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SECONDARY outcome
Timeframe: Baseline; week 12,18The number of subjects who rated their intensity of pruritus as 0=none, 1=mild, 2-moderate, 3=severe. The verbal rating scale measures the intensity of pruritus. Subjects are asked to rate their pruritus intensity as 0=none; 1= mild; 2=moderate; and 3=severe/intense. Scores range from 0 to 3, with higher scores indicating a worse outcome.
Outcome measures
| Measure |
Dupilumab
n=9 Participants
Subcutaneous (SC) dupilumab selected for this study was 300 mg every 2 weeks for 18 weeks.
Dupilumab 300Mg Solution for Injection: Subcutaneous (SC) dupilumab selected for this study was 300 mg every 2 weeks for 18 weeks.
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|---|---|
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Verbal Rating Scale (VRS) Score
Week 18-Severe
|
0 Participants
|
|
Verbal Rating Scale (VRS) Score
Baseline-None
|
0 Participants
|
|
Verbal Rating Scale (VRS) Score
Baseline-Mild
|
0 Participants
|
|
Verbal Rating Scale (VRS) Score
Baseline-Moderate
|
4 Participants
|
|
Verbal Rating Scale (VRS) Score
Baseline-Severe
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5 Participants
|
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Verbal Rating Scale (VRS) Score
Week 12-None
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1 Participants
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Verbal Rating Scale (VRS) Score
Week 12-Mild
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4 Participants
|
|
Verbal Rating Scale (VRS) Score
Week 12-Moderate
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3 Participants
|
|
Verbal Rating Scale (VRS) Score
Week 12-Severe
|
0 Participants
|
|
Verbal Rating Scale (VRS) Score
Week 18-None
|
2 Participants
|
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Verbal Rating Scale (VRS) Score
Week 18-Mild
|
4 Participants
|
|
Verbal Rating Scale (VRS) Score
Week 18-Moderate
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2 Participants
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SECONDARY outcome
Timeframe: Baseline; 18 WeeksThis is a validated 29 question quality life instrument for patients with chronic liver disease evaluating systemic symptoms, fatigue, physical activity, emotional function, and worry. Subjects are asked to respond to each question using the following scale: 6=all of the time; 5=most of the time; 4=a good bit of the time; 3=some of the time; 2=a little of the time; 1=hardly any of the time; and 0=none of the time. Total scores range from 0 to 174 with lower scores indicating better health-related quality of life.
Outcome measures
| Measure |
Dupilumab
n=9 Participants
Subcutaneous (SC) dupilumab selected for this study was 300 mg every 2 weeks for 18 weeks.
Dupilumab 300Mg Solution for Injection: Subcutaneous (SC) dupilumab selected for this study was 300 mg every 2 weeks for 18 weeks.
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|---|---|
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Change in Chronic Liver Disease Questionnaire (CLDQ) Score
|
25.7 score on a scale
Standard Deviation 38.7
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SECONDARY outcome
Timeframe: Baseline; 18 WeeksThis is a multidimensional questionnaire designed to assess the degree, duration, direction, disability and distribution of pruritus longitudinally with scoring ranging from 5=no pruritus/well-controlled to 25=severe pruritus/poorly controlled, with higher scores indicating a worse outcome.
Outcome measures
| Measure |
Dupilumab
n=9 Participants
Subcutaneous (SC) dupilumab selected for this study was 300 mg every 2 weeks for 18 weeks.
Dupilumab 300Mg Solution for Injection: Subcutaneous (SC) dupilumab selected for this study was 300 mg every 2 weeks for 18 weeks.
|
|---|---|
|
Change in 5D Pruritus Score
|
-7.3 score on a scale
Standard Deviation 4.6
|
Adverse Events
Dupilumab
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place