Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4

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.