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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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To investigate the potential efficacy of dupilumab in the treatment of moderate to severe chronic hepatic pruritus.
This is a 22-week (2 week screening, 18-week treatment period followed by a 2 week followup), phase II, open label, exploratory study to investigate the potential efficacy of FDA approved dupilumab in the treatment of adults with moderate to severe chronic hepatic pruritus. Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained, baseline values will be established and subjects will begin treatment and follow-up for the next 20 weeks. A final visit will be needed for evaluation and questionnaire completion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dupilumab | Experimental | Subcutaneous (SC) dupilumab selected for this study is 300 mg every 2 weeks for 18 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab 300Mg Solution for Injection | Drug | Subcutaneous (SC) dupilumab selected for this study is 300 mg every 2 weeks for 18 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak Pruritus Numerical Rating Score (PRNS) | 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. | Baseline; 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weekly Average Peak Pruritus Numerical Rating Score (PRNS) ≥3 From Baseline | 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?". Scores range from 0 to 10 with higher scores indicating a worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Sluzevich, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Change in Peak Pruritus Numerical Rating Score (PRNS) | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; 20 weeks |
|
Adverse events were collected from the time of informed consent through study completion, approximately 22 weeks.
The adverse event definition used in this study was: An untoward or undesirable experience associated with the use of a medical product (i.e. drug, device, biologic) in a patient or research subject. Adverse events were collected through specific questioning and physical examinations.
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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 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Sluzevich, M.D. | Mayo Clinic | 904-953-6192 | sluzevich.jason@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2020 | Oct 20, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
| D012996 | Solutions |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Baseline; week 6,12,18 |
| Verbal Rating Scale (VRS) Score | The 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. | Baseline; week 12,18 |
| Change in Chronic Liver Disease Questionnaire (CLDQ) Score | This 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. | Baseline; 18 Weeks |
| Change in 5D Pruritus Score | This 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. | Baseline; 18 Weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change in Weekly Average Peak Pruritus Numerical Rating Score (PRNS) ≥3 From Baseline | 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?". Scores range from 0 to 10 with higher scores indicating a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline; week 6,12,18 |
|
|
|
| Secondary | Verbal Rating Scale (VRS) Score | The 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. | Posted | Count of Participants | Participants | Baseline; week 12,18 |
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|
|
|
| Secondary | Change in Chronic Liver Disease Questionnaire (CLDQ) Score | This 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; 18 Weeks |
|
|
|
|
| Secondary | Change in 5D Pruritus Score | This 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; 18 Weeks |
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|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
|
| Baseline-Severe |
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| Week 12-None |
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| Week 12-Mild |
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| Week 12-Moderate |
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| Week 12-Severe |
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| Week 18-None |
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| Week 18-Mild |
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| Week 18-Moderate |
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| Week 18-Severe |
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| Superiority |