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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
1x 100 mg tablet
2x 5 mg tablets
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
Ratio of the AUC-last at Week 15 (after multiple doses of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates
AUC-last = area under the plasma concentration curve from time 0 to the last quantifiable observation
Time frame: Day -7 and Week 15
Ratio of the Cmax at Week 15 (after multiple doses of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates
Cmax = maximum observed plasma concentration
Time frame: Day -7 and Week 15
Ratio of the AUC-last on Day 8 (after a single dose of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates
AUC-last = area under the plasma concentration curve from time 0 to the last quantifiable observation
Time frame: Day -7 and Day 8
Ratio of the Cmax on Day 8 (after a single dose of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates
Cmax = maximum observed plasma concentration
Time frame: Day -7 and Day 8
Ratio of the AUC-inf on Day 8 (after a single dose of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates
AUC-inf = area under the plasma concentration curve from time 0 to infinity
Time frame: Day -7 and Day 8
Number of adverse events
Time frame: From Day 1 up to Week 30
Presence of anti-drug antibodies (yes/no)
Time frame: From Day 1 up to Week 30
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1x 20 mg capsule
1x 100 mg tablet
1 mL of 2 mg/mL oral solution/syrup
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
...and 2 more locations