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Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3 (ECZema TRAlokinumab Trial no. 3)

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: NCT03363854
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Tracking Information
First Submitted Date  ICMJE December 1, 2017
First Posted Date  ICMJE December 6, 2017
Last Update Posted Date January 29, 2020
Actual Study Start Date  ICMJE February 22, 2018
Actual Primary Completion Date October 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2017)
  • 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).
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2017)
  • 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.
  • Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (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'.
  • Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16 [ Time Frame: Week 0 to Week 16 ]
    The 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 health-related quality of life (HRQoL) 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 HRQoL.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3 (ECZema TRAlokinumab Trial no. 3)
Official Title  ICMJE A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Subjects With Moderate to Severe Atopic Dermatitis Who Are Candidates for Systemic Therapy
Brief Summary

Primary objective:

To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD).

Secondary objectives:

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

To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 32 weeks.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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 investigational medicinal products (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 health-care professional 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
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Tralokinumab(initial)responders-> Tralokinumab(continuation A)

    Week 0 to 16 (initial period):

    Tralokinumab loading SC injection on Day 0 followed by tralokinumab injection regimen A.

    Week 16 to 32 (continuation period):

    Tralokinumab continuation SC injection regimen A.

    Intervention: Drug: Tralokinumab
  • Experimental: Tralokinumab(initial)responders-> Tralokinumab(continuation B)

    Week 0 to 16 (initial period):

    Tralokinumab loading SC injection on Day 0 followed by tralokinumab injection regimen A.

    Week 16 to 32 (continuation period):

    Tralokinumab continuation SC injection regimen B.

    Intervention: Drug: Tralokinumab
  • Experimental: Tralokinumab(initial)non-respon-> Tralokinumab(continuation A)

    Week 0 to 16 (initial period):

    Tralokinumab loading SC injection on Day 0 followed by tralokinumab injection regimen A.

    Week 16 to 32 (continuation period):

    Tralokinumab continuation SC injection regimen A.

    Intervention: Drug: Tralokinumab
  • Experimental: Placebo (initial)non-respon-> Tralokinumab(continuation A)

    Week 0 to 16 (initial period):

    Placebo loading SC injection on Day 0 followed by placebo injection regimen A.

    Week 16 to 32 (continuation period):

    Tralokinumab continuation SC injection regimen A.

    Interventions:
    • Drug: Tralokinumab
    • Drug: Placebo
  • Placebo Comparator: Placebo(initial)responders-> Placebo(continuation A)

    Week 0 to 16 (initial period):

    Placebo loading SC injection on Day 0 followed by placebo injection regimen A.

    Week 16 to 32 (continuation period):

    Placebo continuation SC injection regimen A.

    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2019)
380
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2017)
369
Actual Study Completion Date  ICMJE September 26, 2019
Actual Primary Completion Date October 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects for whom TCS are medically inadvisable e.g., due to important side effects or safety risks in the opinion of the investigator.
  • 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 TCS, topical calcineurin inhibitors (TCI), or topical phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomisation.
  • Receipt of any marketed biological therapy (i.e. immunoglobulin, anti- immunoglobulin E) including dupilumab or investigational biologic agents within 3 months or 5 half-lives, whichever is longer 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.
  • Tuberculosis requiring treatment within the 12 months prior to screening.
  • Known primary immunodeficiency disorder.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Germany,   Netherlands,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03363854
Other Study ID Numbers  ICMJE LP0162-1339
2017-002065-21 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party LEO Pharma
Study Sponsor  ICMJE LEO Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical expert LEO Pharma
PRS Account LEO Pharma
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP