Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-24 @ 2:38 PM
NCT ID:
NCT04256759
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04256759
Study Brief:
Protocol Section:
NCT04256759