NCT03556592 is a Phase 1 clinical trial of Tralokinumab in Atopic Dermatitis, sponsored by LEO Pharma.

Who is sponsoring NCT03556592?

NCT03556592 is sponsored by LEO Pharma.

What drugs are being tested in NCT03556592?

Interventions in NCT03556592: Tralokinumab, Caffeine, Warfarin, Omeprazole, Metoprolol, Midazolam Hydrochloride.

What condition does NCT03556592 study?

NCT03556592 studies Atopic Dermatitis.

Is NCT03556592 still recruiting?

NCT03556592 is currently completed. Last updated 24 February 2025.

Last reviewed 2025-02-24 · How we verify

NCT03556592

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 24 February 2025

What this trial tests

Phase 1 trial testing Tralokinumab in Atopic Dermatitis in 40 participants. Completed in 20 June 2020.

Timeline

13 August 2018

Primary endpoint
16 March 2020

20 June 2020

Quick facts

Lead sponsor	LEO Pharma
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	13 August 2018
Primary completion	16 March 2020
Estimated completion	20 June 2020
Sites	12 locations across United States, Netherlands, France

Drugs / interventions tested

Tralokinumab
Caffeine (caffeine) — full drug profile →
Warfarin (warfarin) — full drug profile →
Omeprazole (omeprazole) — full drug profile →
Metoprolol (metoprolol) — full drug profile →
Midazolam Hydrochloride (Midazolam Hydrochloride) — full drug profile →

Conditions studied

Atopic Dermatitis — all drugs for Atopic Dermatitis →

Sponsor

LEO Pharma — full company profile →

Who can join

18 and older, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Selective IL-13 inhibitors for the treatment of atopic dermatitis.
Gonçalves F, Freitas E, Torres T. · · 2021 · cited 33× · PMID 33889195 · DOI 10.7573/dic.2021-1-7
Tralokinumab: First Approval.
Duggan S. · · 2021 · cited 32× · PMID 34406631 · DOI 10.1007/s40265-021-01583-1
STAT signaling in polycystic kidney disease.
Strubl S, Torres JA, Spindt AK, Pellegrini H, et al · · 2020 · cited 17× · PMID 32325185 · DOI 10.1016/j.cellsig.2020.109639
IL-13 inhibition in the treatment of atopic dermatitis - new and emerging biologic agents.
Teixeira C, Yilmaz O, Bernardo D, Torres T. · · 2024 · cited 7× · PMID 39558725 · DOI 10.1177/03000605241286832
A systematic review on disease-drug-drug interactions with immunomodulating drugs: A critical appraisal of risk assessment and drug labelling.
de Jong LM, Klomp SD, Treijtel N, Rissmann R, et al · · 2022 · cited 5× · PMID 35484780 · DOI 10.1111/bcp.15372

Verify or expand the search:

Other trials of Tralokinumab

Trials testing the same drug.

NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis · Phase 4 · not yet recruiting
NCT05958407 — A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Ecze · Phase 3 · completed
NCT05938478 — Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT · recruiting
NCT05388760 — Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Tria · Phase 2 · active not recruiting
NCT05194540 — Efficacy and Safety of Tralokinumab Administered by an Autoinjector in Adults and Adolescents With Moderate to Severe At · Phase 3 · completed

Other recruiting trials for Atopic Dermatitis

Currently open trials in the same condition.

NCT07262983 — Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopi · Phase 1 · recruiting
NCT07445919 — A Clinical Study to Evaluate SM17 for Atopic Dermatitis · Phase 2 · recruiting
NCT07488065 — A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants · Phase 1 · recruiting
NCT07467564 — The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatit · recruiting
NCT07358156 — A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and E · Phase 1 · recruiting

Other LEO Pharma trials

Trials by the same sponsor.

NCT07335588 — A 52-Week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream in Adult Participants With Lichen Sclerosus · Phase 3 · not yet recruiting
NCT07013201 — A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to · Phase 2 · recruiting
NCT06444867 — A Study to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of LEO 15896 · Phase 1 · completed
NCT06311682 — A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and · Phase 3 · recruiting
NCT05923099 — A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic De · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03556592 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by LEO Pharma
Last refreshed: 24 February 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03556592.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing