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Completed

NCT Number: NCT03587805

Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND

The purpose of this extension trial is to evaluate the long-term safety of tralokinumab.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

LEO Pharma Investigational Site, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Completed the treatment period(s) of one of the parent trials: LP0162-1325, -1326, -1334, -1339, -1341, -1342, -1343, -1346, or TRA-WEI-0015-I.
  • Complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
  • Able and willing to self-administer tralokinumab treatment (or have it administered by a caregiver) at home after the initial 3 injection visits at the trial site (in this trial).
  • Stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.

Exclusion criteria

  • Any condition that required permanent discontinuation of trial treatment in the parent trial.
  • More than 26 weeks have elapsed since the subject received the last injection of investigational medicinal product (IMP) in the parent trial (to be assessed at baseline).
  • Subjects who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to tralokinumab by the investigator, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject.
  • Subjects who, during their participation in the parent trial, developed an AE that was deemed related to tralokinumab by the investigator and led to temporary discontinuation of trial treatment, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject.
  • Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to baseline.
  • Treatment with topical phosphodiesterase 4 inhibitors or topical JAK inhibitors within 2 weeks prior to baseline.
  • Clinically significant infection within 4 weeks prior to baseline.
  • A helminth parasitic infection within 6 months prior to the date when informed consent is obtained.
  • Tuberculosis requiring treatment within 12 months prior to screening.
  • Known primary immunodeficiency disorder.

Treatment and study plan

Tralokinumab

Drug

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.

Primary outcomes

  1. Number of Adverse Events From Baseline Through the Last Treatment Visit (up to Week 268)

    Time frame: From Week 0 up to Week 268

Secondary outcomes

  1. Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248

    Time frame: From Week 16 up to Week 248

    The IGA is an instrument used in clinical trials to rate the severity of the subject's global atopic dermatitis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  2. At Least 75% Reduction in Eczema Area and Severity Index (EASI75) Relative to Baseline in Parent Trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248

    Time frame: From Week 16 up to Week 248

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe or more extensive condition.

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

An Open-label, Single-arm, Multi-centre, Long-term Extension Trial to Evaluate the Safety and Efficacy of Tralokinumab in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Clinical Trials

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jul 16, 2018
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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