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

Completed · Phase 1

Conditions studied: Atopic Dermatitis

In brief

The purpose of this trial is to investigate if tralokinumab changes the metabolism of selected CYP substrates in adults with moderate-to-severe AD after: * 14 weeks of treatment with tralokinumab * a single dose of tralokinumab

Key facts

Study ID

NCT03556592

Run by

LEO Pharma

People needed

40

Starts

2018-08-13

Expected to finish

2020-06-20

Last updated by the study team

2025-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• LEO Pharma Investigational Site — Little Rock, Arkansas, United States
• LEO Pharma Investigational Site — Rogers, Arkansas, United States
• LEO Pharma Investigational Site — San Diego, California, United States
• LEO Pharma Investigational Site — Doral, Florida, United States
• LEO Pharma Investigational Site — Miami, Florida, United States
• LEO Pharma Investigational Site — Miami, Florida, United States
• LEO Pharma Investigational Site — Quincy, Massachusetts, United States
• LEO Pharma Investigational Site — Spartanburg, South Carolina, United States
• LEO Pharma Investigational Site — Norfolk, Virginia, United States
• LEO Pharma Investigational Site — Nice, France
• LEO Pharma Investigational Site — Paris, France
• LEO Pharma Investigational Site — Leiden, Netherlands

Full record on ClinicalTrials.gov

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