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

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 13, 2018

Primary Completion Date

March 16, 2020

Study Completion Date

June 20, 2020

Conditions
Atopic Dermatitis
Interventions
DRUG

Tralokinumab

Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.

DRUG

Caffeine

1x 100 mg tablet

DRUG

Warfarin

2x 5 mg tablets

DRUG

Omeprazole

1x 20 mg capsule

DRUG

Metoprolol

1x 100 mg tablet

DRUG

Midazolam Hydrochloride

1 mL of 2 mg/mL oral solution/syrup

Trial Locations (12)

23502

LEO Pharma Investigational Site, Norfolk

29303

LEO Pharma Investigational Site, Spartanburg

33015

LEO Pharma Investigational Site, Miami

33122

LEO Pharma Investigational Site, Doral

33144

LEO Pharma Investigational Site, Miami

72212

LEO Pharma Investigational Site, Little Rock

72758

LEO Pharma Investigational Site, Rogers

75010

LEO Pharma Investigational Site, Paris

92119

LEO Pharma Investigational Site, San Diego

02169

LEO Pharma Investigational Site, Quincy

06202

LEO Pharma Investigational Site, Nice

2333 ZC

LEO Pharma Investigational Site, Leiden

Sponsors

Lead Sponsor

All Listed Sponsors
lead

LEO Pharma

INDUSTRY

NCT03556592 - Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4 | Biotech Hunter | Biotech Hunter