Study to Investigate the Effect of Rocatinlimab (AMG 451) on the Pharmacokinetics of Multiple Cytochrome P450 (CYP450) Substrates in Participants With Moderate to Severe Atopic Dermatitis

Prior treatment

• Have previously completed or withdrawn from this study or any other study investigating rocatinlimab or have previously received a dose of an investigational drug within the past 90 days or 5 half-lives, whichever is longer, prior to Check-in
• The use of any of the following treatments within 4 weeks before Check-in:
  • Systemic corticosteroids
  • Immunosuppressive/immunomodulating drugs
• The use of any of the following treatments within one week before Check-in:
  • Topical corticosteroids of any super-high potency
  • Topical phosphodiesterase 4 (PDE4) inhibitors
  • Phototherapy
• Administration, within 14 days before baseline or within a period of 5 times the elimination half-life of the medication before baseline, whichever is longer, of any medication that is a known inducer or inhibitor of either one or more of the following cytochrome P450 (CYP) enzymes: CYP3A4, CYP2C19, CYP2C9, CYP2D6, and CYP1A2. Participants who are on any of these medications at the time of screening and cannot be safely taken off these medications will be excluded from the study.
• Any contraindication to one or more of the following drugs, according to the applicable labeling:
  • Midazolam
  • Omeprazole
  • Warfarin (and Vitamin K)
  • Caffeine
  • Metoprolol
• Consumption of any 1 or more of the following food items and/or beverages within 1 week prior to Check-in:
  • Grapefruit or grapefruit juice, apple or apple juice, orange or orange juice, lemons or lemon juice, limes or lime juice
  • Vegetables from the mustard green family (eg, broccoli)
  • Charbroiled meats
  • Caffeinated beverages, foods or drugs containing caffeine
• History of alcoholism or drug/chemical abuse within 1 year prior to Check-in or regular alcohol consumption (\>14 units per week for males and \>7 units for females)
• Active, chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals at screening or Check-in
• Superficial skin infections, including tinea infections, within 2 weeks prior to Check-in
• Positive hepatitis B or hepatitis C panel and/or positive human immunodeficiency virus test, at screening as per Center for Disease Control interpretation. Participants whose hepatitis B and C results are compatible with prior immunity (resulting from inoculation) may be included. Participants with positive hepatitis B core antibody will be excluded.
• Active malignancy, multiple myeloma, myeloproliferative or lymphoproliferative disorder, or a history of any of these conditions within 5 years prior to informed consent (except curatively treated in situ cervical carcinoma, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma)
• Diagnosis of a helminth parasitic infection within 6 months prior to screening that had not been treated with or failed to respond to standard of care therapy.
• History of suicidal ideation (thoughts), suicide-related behaviors, suicide attempt(s), depression or major psychiatric illness within 6 months prior to signing the informed consent

Other illness

• History of acquired, common variable, primary or secondary immunodeficiency

Lab values

• Presence of any one or more of the following lab abnormalities at screening or Check-in:
  • Platelet count \<100k /µL, international normalized ratio (INR)\>1.2, prothrombin time (PT)\>13.5 sec or partial thromboplastin time (PTT)\>35 sec

Other

• Smoke more than 10 cigarettes or use the equivalent (as determined by site staff) tobacco- or nicotine-containing products per day and unwilling to adhere to smoking restrictions.
• Poor metabolizers for CYP2C9, CYP2C19, or CYP2D6 based on genotyping
• Female participants who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study through 18 weeks after the end of study visit
• Unwilling to adhere to contraceptive requirements through 18 weeks after the end of study visit
• Male participant with a pregnant partner or partner planning to become pregnant while the participant is on study through 18 weeks after the end of study visit

• Male or female participant, aged 18 to 65 years
• Diagnosis of AD, defined as diagnosis of AD for at least 6 months before signing of informed consent
• Eczema Area Severity Index score ≥8 at the screening and Check-in
• Investigator's Global Assessment (IGA) score ≥3 (on the 0 to 4 IGA scale) at screening and Check-in
• ≥7% Body Surface Area of AD involvement at initial screening
• History of inadequate response to topical corticosteroid therapy (TCS) of medium to higher potency within 6 months (with or without topical calcineurin inhibitors \[TCI\]) or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
• Provide signed informed consent