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Trial record 3 of 7 for:    ECZTRA

Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1) (ECZTRA 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03131648
Recruitment Status : Completed
First Posted : April 27, 2017
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:

Primary objective:

To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe AD.

Secondary objectives:

To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health related quality of life compared with placebo.

Maintenance objective:

To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared to placebo for subjects achieving clinical response at Week 16.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 802 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:

Neither the subject nor any of the investigator or LEO staff who are involved in the treatment or clinical evaluation and monitoring of the subjects will be aware of the treatment received. The packaging and labelling of the IMPs will contain no evidence of their identity.

Since tralokinumab and placebo are visually distinct and not matched for viscosity, IMP will be handled and administered by a qualified, unblinded HCP at the site who will not be involved in the management of trial subjects and who will not perform any of the assessments.

Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Monotherapy in Subjects With Moderate to Severe Atopic Dermatitis Who Are Candidates for Systemic Therapy
Actual Study Start Date : May 30, 2017
Actual Primary Completion Date : August 7, 2018
Actual Study Completion Date : October 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Tralokinumab initial period -> Tralokinumab maintenance A

Week 0 to Week 16:

tralokinumab loading SC injection at Day 0 - loading dose tralokinumab SC injection regimen A

Week 16 to Week 52:

tralokinumab maintenance SC injection regimen A

Drug: Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration

Experimental: Tralokinumab initial period -> Tralokinumab maintenance B

Week 0 to Week 16:

tralokinumab loading SC injection at Day 0 - loading dose tralokinumab SC injection regimen A

Week 16 to Week 52:

tralokinumab maintenance SC injection regimen B

Drug: Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration

Experimental: Tralokinumab initial period -> Placebo maintenance

Week 0 to Week 16:

tralokinumab loading SC injection at Day 0 - loading dose tralokinumab SC injection regimen A

Week 16 to Week 52:

placebo maintenance SC injection regimen A

Drug: Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration

Drug: Placebo
Placebo contains the same excipients, in the same concentration only lacking tralokinumab

Placebo Comparator: Placebo initial period -> Placebo maintenance

Week 0 to Week 16:

placebo loading SC injection at Day 0 - loading dose placebo SC injection regimen A

Week 16 to Week 52:

placebo maintenance SC injection regimen A

Drug: Placebo
Placebo contains the same excipients, in the same concentration only lacking tralokinumab

Experimental: Tralokinumab initial period -> Open-label tralokinumab

Week 0 to Week 16:

tralokinumab loading SC injection at Day 0 - loading dose tralokinumab SC injection regimen A

Week 16 to Week 52:

tralokinumab maintenance SC injection regimen A - open-label with allowed use of topical corticosteroids

Drug: Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration

Experimental: Placebo initial period -> Open-label tralokinumab

Week 0 to Week 16:

placebo loading SC injection at Day 0 - loading dose placebo SC injection regimen A

Week 16 to Week 52:

tralokinumab maintenance SC injection regimen A - open-label with allowed use of topical corticosteroids

Drug: Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration

Drug: Placebo
Placebo contains the same excipients, in the same concentration only lacking tralokinumab




Primary Outcome Measures :
  1. Subjects with Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Week 16 [ Time Frame: Week 0 to Week 16 ]
    The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  2. Subjects achieving at least 75% reduction in Eczema Area and Severity Index [EASI] [ Time Frame: Week 0 to Week 16 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.


Secondary Outcome Measures :
  1. Change in Scoring Atopic Dermatitis (SCORAD) from baseline to Week 16 [ Time Frame: Week 0 to Week 16 ]
    The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.

  2. Reduction of Worst Daily Pruritus numeric rating scale (weekly average) of at least 4 from baseline to Week 16. [ Time Frame: Week 0 to Week 16 ]
    Subjects will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.

  3. Change in Dermatology Life Quality Index (DLQI) score from baseline to Week 16 [ Time Frame: Week 0 to Week 16 ]
    The Dermatology Life Quality Index (DLQI) is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life (QoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4 point Likert scale (0 = not at all ⁄not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor QoL.



Information from the National Library of Medicine

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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:

  • Age 18 and above
  • Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
  • Diagnosis of AD for ≥1 year.
  • Subjects who have a recent history of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable.
  • AD involvement of ≥10% body surface area at screening and baseline.
  • Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation

Exclusion Criteria:

  • Active dermatologic conditions that may confound the diagnosis of AD.
  • Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
  • Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation.
  • Treatment with topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI) within 2 weeks prior to randomisation.
  • Active skin infection within 1 week prior to randomisation.
  • Clinically significant infection within 4 weeks prior to randomisation.
  • A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
  • History of anaphylaxis following any biologic therapy.
  • Tuberculosis requiring treatment within the 12 months prior to screening.
  • Known primary immunodeficiency disorder.
  • Alanine aminotransferase or aspartate aminotransferase level ≥2.0 times the upper limit of normal at screening.
  • Positive hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B core antibody or hepatitis C virus antibody serology at screening.

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): NCT03131648


Locations
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Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: Andreas Wollenberg, Prof. Dr. med. Department of Dermatology and Allergy, Ludwig-Maximilian University Munich, Germany

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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03131648    
Other Study ID Numbers: LP0162-1325
2016-004200-65 ( EudraCT Number )
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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