PruritusPhase 2NCT04256759
Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus
A Phase 2 study testing Dupilumab 300Mg Solution for Injection in people with Pruritus, run by Mayo Clinic at 1 site in United States.
Trial summary
To investigate the potential efficacy of dupilumab in the treatment of moderate to severe chronic hepatic pruritus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pruritus
- What is being tested?
- Dupilumab 300Mg Solution for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 6 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and/or female subjects 18 years or older with chronic pruritus of moderate to severe severity in the setting of intrahepatic or extrahepatic cholestatic liver disease. Chronic is defined as greater than 6 weeks of symptom duration. Pruritus severity is based on the peak pruritus numerical rating score of ≥ 4 (moderate severity).
- Documentation of a personally signed and dated informed consent indicating that the subject or their legally acceptable representative has been informed of all pertinent aspects of the trial.
- Willingness and ability to comply with scheduled clinic visits, physical exams, laboratory tests, questionnaires, effective contraception use, and other trial procedures.
Who cannot join
- Male and/or female subjects under 18 years of age.
- Pruritus due to a primary inflammatory skin dermatosis or other forms of psychogenic pruritus utilizing skin biopsies as needed.
- Pregnant females
- History of intrahepatic cholestasis of pregnancy
- Any form of chronic hepatic pruritus associated with underlying malignancy
- Liver transplant recipients
Show all 11Show fewer
- Allergy to dupilumab or its ingredients
- Inability to provide informed consent
- Concomitant use of selective opioid antagonists
- Subjects with severe asthma (requiring high-dose inhaled or systemic corticosteroids) will be excluded from the study.
- Patients with known helminth infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus: an Open-Label, Single-Arm, Exploratory Study
To investigate the potential efficacy of dupilumab in the treatment of moderate to severe chronic hepatic pruritus.
Read the detailed description
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.
- Conditions
- Pruritus
- Being tested
- Dupilumab 300Mg Solution for Injection
- Keywords
- Dupilumab
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dupilumab 300Mg Solution for InjectionDrug
Also called Dupixent
Subcutaneous (SC) dupilumab selected for this study is 300 mg every 2 weeks for 18 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Experimental | Subcutaneous (SC) dupilumab selected for this study is 300 mg every 2 weeks for 18 weeks. Receives: Drug: Dupilumab 300Mg Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; 20 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline; 18 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Sep 2020
- Primary completion6 Sep 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PruritusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Principal investigator, Jason Sluzevich MD, Mayo Clinic
- Investigators
- Jason Sluzevich, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256759
- Sponsor's protocol ID
- 19-002757
- Status last verified
- Nov 2025
- First submitted
- 3 Feb 2020
- Last updated
- 21 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus: an Open-Label, Single-Arm, Exploratory Study
- ClinicalTrials.gov ID
- NCT04256759
- Acronym / sponsor ID
- 19-002757
- Conditions
- Pruritus
- Keywords
- Dupilumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Posted 21 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the potential efficacy of dupilumab in the treatment of moderate to severe chronic hepatic pruritus.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Experimental | Drug: Dupilumab 300Mg Solution for InjectionSubcutaneous (SC) dupilumab selected for this study is 300 mg every 2 weeks for 18 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and/or female subjects 18 years or older with chronic pruritus of moderate to severe severity in the setting of intrahepatic or extrahepatic cholestatic liver disease. Chronic is defined as greater than 6 weeks of symptom duration. Pruritus severity is based on the peak pruritus numerical rating score of ≥ 4 (moderate severity).
- Documentation of a personally signed and dated informed consent indicating that the subject or their legally acceptable representative has been informed of all pertinent aspects of the trial.
- Willingness and ability to comply with scheduled clinic visits, physical exams, laboratory tests, questionnaires, effective contraception use, and other trial procedures.
Key exclusion criteria (11 listed)
- Male and/or female subjects under 18 years of age.
- Pruritus due to a primary inflammatory skin dermatosis or other forms of psychogenic pruritus utilizing skin biopsies as needed.
- Pregnant females
- History of intrahepatic cholestasis of pregnancy
- Any form of chronic hepatic pruritus associated with underlying malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dupilumab 300Mg Solution for InjectionAlso: DupixentSubcutaneous (SC) dupilumab selected for this study is 300 mg every 2 weeks for 18 weeks. | Drug | Dupilumab |
Primary outcome
Change in Peak Pruritus Numerical Rating Score (PRNS)
Time frame: Baseline; 20 weeks
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.
4 secondary outcomes
Change in Weekly Average Peak Pruritus Numerical Rating Score (PRNS) ≥3 From Baseline
Time frame: Baseline; week 6,12,18
Verbal Rating Scale (VRS) Score
Time frame: Baseline; week 12,18
Change in Chronic Liver Disease Questionnaire (CLDQ) Score
Time frame: Baseline; 18 Weeks
Change in 5D Pruritus Score
Time frame: Baseline; 18 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Sluzevich, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dupilumab 300Mg Solution for Injection in people with Pruritus, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peak Pruritus Numerical Rating Score (PRNS) (time frame: Baseline; 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.