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Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 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
Results First Posted : January 14, 2021
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Description
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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.


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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 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 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
Official Title: 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
Actual Study Start Date : February 22, 2018
Actual Primary Completion Date : March 8, 2019
Actual Study Completion Date : September 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Steroids

Arms and Interventions
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Arm Intervention/treatment
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.

 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)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.

 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)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.

 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)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.

 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)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.

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


Outcome Measures
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Primary Outcome Measures :
  1. Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 [ Time Frame: Week 16 ]
    IGA is used to evaluate the severity of atopic dermatitis. It is a 5-point score ranging from 0 (clear) to 4 (severe).

  2. Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16 [ Time Frame: Week 16 ]
    EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.


Secondary Outcome Measures :
  1. 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 ]
    Worst Daily Pruritus NRS is used by the participant to evaluate their worst itch severity over the past 24 hours. The score ranges from 0 ('no itch') to 10 ('worst itch imaginable') on an 11-point scale.

  2. Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16 [ Time Frame: Week 0 to Week 16 ]
    SCORAD is used to evaluate the extent and severity of atopic dermatitis as well as subjective symptoms. The score ranges from 0 to 103 with a higher score indicating a more extensive and/or severe condition.

  3. Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16 [ Time Frame: Week 0 to Week 16 ]
    DLQI is used by the participant to evaluate the impact of their condition on 10 different aspects of health-related quality of life (HRQoL) over the last week. Each item is scored on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much). The total score which is the sum of the 10 items ranges from 0 to 30, with a higher score indicating a poorer HRQoL.

  4. Frequency of Anti-drug Antibodies (ADA) [ Time Frame: Week 0 to Week 16, Week 16 to Week 32 ]
    Presence of ADA from Week 0 to Week 32 was measured. Data were reported in the following categories: positive (presence of ADA at baseline and/or presence of ADA at at least 1 post-baseline assessment), perishing (presence of ADA at baseline and absence of ADA at all post-baseline assessments), negative (absence of ADA at all assessments), no post-baseline ADA assessment. Perishing ADAs were not assessed in the continuation treatment period.

  5. Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes [ Time Frame: Week 1-2 to Week 15-16 ]
    Assessed as the amount of TCS weighed from previous visits, assuming no TCS was used from the non-returned tubes. Measurements were collected as TCS weight (g) between the visits.

  6. Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes [ Time Frame: Week 1-2 to Week 15-16 ]
    Assessed as the amount of TCS weighed from previous visits, assuming all TCS was used from the non-returned tubes. Measurements were collected as TCS weight (g) between the visits.

  7. Number of Atopic Dermatitis Flares Through Week 16 [ Time Frame: Week 0 to Week 16 ]
    Assessed as appearance of new flares since previous visit.

  8. Number of Days Without Topical Treatment Use From Baseline to Week 16 [ Time Frame: Week 1 to Week 16 ]
    Participants assessed their use of topical treatment over the past 24 hours using a response scale ('yes', 'no'). Measurements of number of days per week were used in the analysis.

  9. Participants Achieving at Least 50% Reduction in Eczema Area and Severity Index (EASI) at Week 16 [ Time Frame: Week 16 ]
    EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.

  10. Participants Achieving at Least 90% Reduction in Eczema Area and Severity Index (EASI) at Week 16 [ Time Frame: Week 16 ]
    EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.

  11. Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score [ Time Frame: Week 0 to Week 16 ]
    EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.

  12. Participants Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16 [ Time Frame: Week 16 ]
    SCORAD is used to evaluate the extent and severity of atopic dermatitis as well as subjective symptoms. The score ranges from 0 to 103 with a higher score indicating a more extensive and/or severe condition.

  13. Participants Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16 [ Time Frame: Week 16 ]
    SCORAD is used to evaluate the extent and severity of atopic dermatitis as well as subjective symptoms. The score ranges from 0 to 103 with a higher score indicating a more extensive and/or severe condition.

  14. Change From Baseline to Week 16 in Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) [ Time Frame: Week 0 to Week 16 ]
    Worst Daily Pruritus NRS is used by the participant to evaluate their worst itch severity over the past 24 hours. The score ranges from 0 ('no itch') to 10 ('worst itch imaginable') on an 11-point scale.

  15. Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of at Least 4 Points Among Participants With Baseline DLQI ≥4 [ Time Frame: Week 0 to Week 16 ]
    DLQI is used by the participant to evaluate the impact of their condition on 10 different aspects of health-related quality of life (HRQoL) over the last week. Each item is scored on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much). The total score which is the sum of the 10 items ranges from 0 to 30, with a higher score indicating a poorer HRQoL.

  16. Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 32 Among Participants With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab [ Time Frame: Week 32 ]
    IGA is used to evaluate the severity of atopic dermatitis. It is a 5-point score ranging from 0 (clear) to 4 (severe).

  17. Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 32 Among Participants Who Had Achieved at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab [ Time Frame: Week 32 ]
    EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.
  • 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.
Contacts and Locations
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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): NCT03363854


Locations
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Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Medical expert LEO Pharma
  Study Documents (Full-Text)

Documents provided by LEO Pharma:
Study Protocol  [PDF] August 29, 2018
Statistical Analysis Plan  [PDF] July 15, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03363854    
Other Study ID Numbers: LP0162-1339
2017-002065-21 ( EudraCT Number )
First Posted: December 6, 2017    Key Record Dates
Results First Posted: January 14, 2021
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available to request after results of the trial are available on leopharmatrials.com.
Access Criteria: Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
URL: http://leopharmatrials.com/for-professionals

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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