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:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT03540160
Eligibility Criteria:
Inclusion Criteria:
* Male or female, age 18 years or older at consent.
* Pruritus associated with prurigo nodularis, atopic dermatitis, or psoriasis.
* Female subjects of childbearing potential must be willing to practice highly effective contraception until 5 weeks after last dose of study drug.
* Willing and able to comply with study visits and study related requirements including providing written informed consent.
Exclusion Criteria:
* Malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous malignancies).
* Any known major psychiatric diagnosis, such as major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder, which may confound the assessment of serlopitant safety or efficacy, or interfere with the subject's ability to comply with protocol-mandated activities, within 3 years prior to enrollment.
* Untreated or inadequately treated thyroid, adrenal, or pituitary nodules or disease, or history of thyroid malignancy; or the prescense of any medical condition or disability, that could interfere with the assessment of safety in this study or compromise the safety of the subject.
* Investigational therapy within 4 weeks or 5-half-lives prior to enrollment (whichever is longer) or expected participation in another clinical study involving an investigational product or device during the subject's participation in this study.
* Treatment with other neurokinin-1 receptor (NK1-R) antagonists (e.g., aprepitant, fosaprepitant, rolapitant) within 4 weeks.
* Treatment with strong cytochrome P450 3A4 inhibitors within 4 weeks.
* Currently pregnant or breastfeeding or planning to become pregnant during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03540160
Study Brief:
Protocol Section:
NCT03540160