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 @ 3:55 PM
Ignite Modification Date:
2025-12-24 @ 3:55 PM
NCT ID:
NCT03556592
Eligibility Criteria:
Inclusion Criteria:
* Age 18 and above.
* Diagnosis of AD as defined by the Hanifin and Rajka 1980 criteria for AD.
* History of AD for ≥1 year.
* Subjects who have a recent history of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable.
* AD involvement of ≥10% body surface area at screening and baseline.
* Stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.
* Willingness to abstain from consumption of any 1 or more of the following items in the periods specified:
* ±7 days within each cocktail dosing visit: foods/beverages that affect the CYP system:
* Grapefruit or grapefruit juice, Seville oranges or orange juice, starfruit, pomegranate and cranberry juices, red wine, red grape extract.
* Cruciferous vegetables (for example broccoli).
* Chargrilled meat.
* ±48 hours within each cocktail dosing visit: caffeinated beverages and foods/drugs that contain caffeine.
Exclusion Criteria:
* Administration, within 14 days or 5 half-lives (whichever is longer) prior to Day -7, of any medication that is a known inducer or inhibitor of 1 or more of the following CYP enzymes: CYP3A, CYP2C19, CYP2C9, CYD2D6, and CYP1A2.
* Subjects who are poor metabolisers of CYP2C9, CYP2C19, or CYP2D6, based on genotyping.
* Any contraindication to 1 or more of the following drugs, according to the applicable labelling: caffeine, warfarin, omeprazole, metoprolol, or midazolam.
* Consumption of any 1 or more of the following items in the periods specified:
* ±7 days within each cocktail dosing visit: foods/beverages that affect the CYP system:
* Grapefruit or grapefruit juice, Seville oranges or orange juice, starfruit, pomegranate and cranberry juices, red wine, red grape extract.
* Cruciferous vegetables (for example broccoli).
* Chargrilled meat.
* ±48 hours within each cocktail dosing visit: caffeinated beverages and foods/drugs that contain caffeine.
* Nausea or diarrhoea 1 week prior to Day -7.
* Active dermatologic conditions that may confound the diagnosis of AD.
* Use of tanning beds or phototherapy within 5 weeks prior to Day -7.
* Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 3 weeks prior to Day -7.
* Treatment with topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase 4 inhibitors within 1 week prior to Day -7.
* Receipt of any marketed biological therapy or investigational biologic agent (including immunoglobulin, anti-IgE, or dupilumab):
* Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to Day -7, or until lymphocyte count returns to normal, whichever is longer.
* Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to Day -7.
* Active skin infection within 1 week prior to Day -7.
* Clinically significant infection within 4 weeks prior to Day -7.
* A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
* Tuberculosis requiring treatment within 12 months prior to screening.
* Known primary immunodeficiency disorder.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03556592
Study Brief:
Protocol Section:
NCT03556592