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Trial record 2 of 10 for:    Tralokinumab atopic

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

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ClinicalTrials.gov Identifier: NCT03587805
Recruitment Status : Not yet recruiting
First Posted : July 16, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Tralokinumab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1125 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : September 20, 2018
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : June 7, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Tralokinumab, all subjects

Week 0: subcutaneous (SC) injection of tralokinumab loading dose.

From Week 2 up to Week 140*: SC injection of tralokinumab maintenance dose.

* The length of treatment for each subject will depend on when they enter the trial.

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.




Primary Outcome Measures :
  1. Number of adverse events from baseline through the last treatment visit (up to Week 142) [ Time Frame: From Week 0 up to Week 142 ]

Secondary Outcome Measures :
  1. Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Weeks 16, 56, 80, 104, and 128 [ Time Frame: From Week 16 up to Week 128 ]
    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, 80, 104, and 128 [ Time Frame: From Week 16 up to Week 128 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completed the treatment period(s) of one of the parent trials: LP0162-1325, -1326, -1339, -1341, -1342, or -1346.
  • 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 20 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03587805


Contacts
Contact: LEO Pharma A/S (+1) 877-557-1168 disclosure@leo-pharma.com

  Show 142 Study Locations
Sponsors and Collaborators
LEO Pharma
Investigators
Study Director: Medical expert LEO Pharma

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03587805     History of Changes
Other Study ID Numbers: LP0162-1337
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs