Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Galderma R&D
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Chronic atopic dermatitis (AD) for at least 2 years before the screening visit, and confirmed according to American Academy of Dermatology Consensus Criteria at the time of the screening visit
Eczema Area and Severity Index (EASI) score greater than or equal to (\>=) 16 at both the screening and baseline visits
IGA score \>= 3 (based on the Investigator's Global Assessment \[IGA\] scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits
AD involvement \>=10 percent (%) of body surface area (BSA) at both the screening and baseline visits
Peak (maximum) pruritus numeric rating scale (PP NRS) score of at least 4.0 at both the screening and baseline visit
Documented recent history (within 6 months before the screening visit) of inadequate response to topical medications (topical corticosteroid \[TCS\] with or without topical calcineurin inhibitor \[TCI\])
You may not be if
Body weight less than (\<) 45 kilogram (kg)
Participants meeting 1 or more of the following criteria at screening or baseline: (a) Had an exacerbation of asthma requiring hospitalization in the preceding 12 months; (b) Reporting asthma that has not been well-controlled in the previous 3 months; (c) Asthma Control Test (ACT) \<= 19 (for those with a history of asthma); (d) Peak expiratory flow \< 80% of the predicted value
Participants with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis
Cutaneous infection within 1 week prior to the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks prior to the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks before the screening or baseline visit. Participants may be rescreened once the infection has resolved. Resolution of COVID-19 infection can be confirmed by recovery assessment methods
Requiring rescue therapy for AD during the screening period or expected to require systemic rescue therapy during the treatment period
Positive serology results (hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\], hepatitis C antibody, or human immunodeficiency virus antibody) at the screening visit
Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to Screening
Known active or latent tuberculosis
Treatment with Biologics and their biosimilars within 8 weeks from Screening
Use of Phototherapy or tanning beds within 4 weeks from Screening
Use of medication known as inducer, inhibitor, or competitive substrate of one or more of the following cytochrome (CYP) enzymes: CYP3A4/5, CYP2C19, CYP2C9, CYD2D6, and CYP1A2 within 2 weeks from Screening
Treatment with Midazolam, Omeprazole, Warfarin Sodium, Metoprolol Tartrate within 2 weeks from Screening
History of hypersensitivity or intolerance to CYP substrates and their excipients
Participants for whom administration of the CYP substrates provided in this study is contraindicated or medically inadvisable
Participants with international normalized ratio (INR) \> 1.5
Consumption of any 1 or more of the following food items and/or beverages within 1 week prior to baseline: Grapefruit or grapefruit juice, apple or apple juice, orange or orange juice, lemons or lemon juice, limes or lime juice, cranberries or cranberry juice; Vegetables from the mustard green family (eg, broccoli, kale); Charbroiled meats; Beverages, foods, or drugs containing caffeine
