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

NCT03556592 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-24

No results posted yet for this study

Summary

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

Conditions

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

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Medical expert · LEO Pharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-13
Primary Completion
2020-03-16
Completion
2020-06-20
FDA Drug
Yes

Countries

  • United States
  • France
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03556592 on ClinicalTrials.gov