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:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
NCT ID:
NCT03239106
Eligibility Criteria:
Inclusion Criteria:
Key Inclusion Criteria: A subject who meets all of the following criteria may be included in the study:
* Male and non-pregnant, non-lactating female subjects aged 18 years or older
* Diagnosed with chronic idiopathic pruritus (CIP) with an NRS Itch Score of ≥ 7 at both Screening and Baseline
* Diagnosis of CIP for at least 6 weeks prior to screening
* Willingness to avoid pregnancy or fathering of children
* Ability and willingness to provide written informed consent
* Willing and able to comply with all study requirements and restrictions
* Willing to not participate in any other interventional trial for the duration of their participation
* Subjects must be in good health as determined by medical history, physical examination, electrocardiogram, clinical laboratory tests and vital signs
* Failure of a course 2-week course of treatment with topical triamcinolone 0.1% ointment BID
* Histopathological demonstration of skin eosinophils, mast cell activation, lymphocytic infiltration, and/or dermal edema
Exclusion Criteria:
Key Exclusion Criteria: A subject who meets any of the following criteria will be excluded from the study:
* Chronic pruritus due to a defined primary dermatologic disorder (e.g., atopic dermatitis, psoriasis, etc.)
* Patients with a prior diagnosis of excoriation disorder
* Use of topical treatments for CIP (other than bland emollients) within 1 week of Baseline
* Systemic immunosuppressive or immunomodulating drugs within 4 weeks of Baseline
* Subjects with cytopenias at screening, defined as:
* Leukocytes \< 3 × 109/L.
* Neutrophils \< lower limit of normal.
* Lymphocytes \< 0.5 × 109/L
* Hemoglobin \< 10 g/dL.
* Platelets \< 100 × 109/L.
* Unwilling or unable to follow medication restrictions described in Section 5.6.3, or unwilling or unable to sufficiently washout from use of restricted medication
* Under medical treatment for a skin disease with a therapy listed in the prohibited medications section that may influence the results of the study
* Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal gastrointestinal, endocrine or metabolic dysfunction unless currently controlled and stable, including (but not limited to) the following: Positive for Hepatitis C antibody test (anti-HCF) Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) Positive for HIV (DUO test, p24 antigen)
* Active malignancy
* Active substance abuse or history of substance abuse within 6 months of screening
* History (including family history) or current evidence of congenital long QT syndrome or known acquired QT prolongation
* Exposure to any investigational medication, including placebo, within 60 days of the Baseline Visit
* Subjects who had previously received apremilast
* Subjects with severely impaired liver function (Child-Pugh Class C) or end-stage renal disease on dialysis or at least 1 of the following:
* Serum creatinine \> 1.5 mg/dL
* Alanine aminotransferase or aspartate aminotransferase ≥ 1.5 × upper limit of normal
* Anyone affiliated with the site or sponsor and/or anyone who may consent under duress
* Any other sound medical reason as determined by the Investigator including any condition which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance or may confound results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03239106
Study Brief:
Protocol Section:
NCT03239106