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Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).

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ClinicalTrials.gov Identifier: NCT03526861
Recruitment Status : Completed
First Posted : May 16, 2018
Results First Posted : October 29, 2021
Last Update Posted : October 29, 2021
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:

Primary objective:

To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to <18 years) with 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.

To investigate the safety, immunogenicity, and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 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 healthcare 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, Parallel-group, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) Who Are Candidates for Systemic Therapy
Actual Study Start Date : June 19, 2018
Actual Primary Completion Date : April 15, 2020
Actual Study Completion Date : March 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceA

Week 0 to 16 (initial period):

Tralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A.

Week 16 to 52 (maintenance period):

Tralokinumab (Dose 1) maintenance SC injection regimen A.

Drug: Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.

Experimental: Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceB

Week 0 to 16 (initial period):

Tralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A.

Week 16 to 52 (maintenance period):

Tralokinumab (Dose 1) maintenance SC injection regimen B.

Drug: Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.

Experimental: Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceA

Week 0 to 16 (initial period):

Tralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A.

Week 16 to 52 (maintenance period):

Tralokinumab (Dose 2) maintenance SC injection regimen A.

Drug: Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.

Experimental: Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceB

Week 0 to 16 (initial period):

Tralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A.

Week 16 to 52 (maintenance period):

Tralokinumab (Dose 2) maintenance SC injection regimen B.

Drug: Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.

Experimental: Placebo initial-> Placebo maintenance

Week 0 to 16 (initial period):

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

Week 16 to 52 (maintenance period):

Placebo continuation SC injection regimen A.

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

Experimental: Tralokinumab (Dose1) initial-> Open-label tralokinumab

Week 0 to 16 (initial period):

Tralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A.

Week 16 to 52:

Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids

Drug: Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.

Experimental: Tralokinumab (Dose2) initial-> Open-label tralokinumab

Week 0 to 16 (initial period):

Tralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A.

Week 16 to 52:

Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids

Drug: Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.

Experimental: Placebo initial-> Open-label tralokinumab

Week 0 to 16 (initial period):

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

Week 16 to 52:

Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids

Drug: Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.

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




Primary Outcome Measures :
  1. Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 [ Time Frame: At 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 With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16 [ Time Frame: At 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. Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16 [ Time Frame: At Week 16 ]
    The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.

  2. Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16 [ Time Frame: From 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.

  3. Change in Children's Dermatology Life Quality Index (CDLQI) Score From Baseline to Week 16 [ Time Frame: From Week 0 to Week 16 ]
    The CDLQI 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 various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.

  4. Number of Adverse Events [ Time Frame: From Week 0 to Week 16 ]
    Number of AEs during the Initial treatment period is presented. For a summary of AEs and SAEs by MedDRA system organ class (SOC) and preferred term (PT) during the initial treatment period, maintenance treatment period, open-label treatment period, and safety follow-up period, see the Adverse Events Overview section.

  5. Presence of Anti-drug Antibodies [ Time Frame: From Week 0 to Week 16 ]
    Anti-tralokinumab antibody levels were analysed using a validated bioanalytical method.

  6. Subjects With at Least 50% Reduction in Eczema Area and Severity Index (EASI50) at Week 16. [ Time Frame: At 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.

  7. Subjects With at Least 90% Reduction in Eczema Area and Severity Index (EASI90) at Week 16. [ Time Frame: At 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.

  8. Change in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16 [ Time Frame: From 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.

  9. Subjects With at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD75) at Week 16 [ Time Frame: At Week 16 ]
    The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with a higher values indicating a more extensive and/or severe condition.

  10. Subjects With at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD50) at Week 16 [ Time Frame: At Week 16 ]
    The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with a higher values indicating a more extensive and/or severe condition.

  11. Change in Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) From Baseline to Week 16 [ Time Frame: From Week 0 to Week 16 ]
    The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.

  12. Participants With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 3 From Baseline to Week 16 [ Time Frame: At Week 16 ]
    The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.

  13. Change in Patient Oriented Eczema Measure (POEM) From Baseline to Week 16 [ Time Frame: From Week 0 to Week 16 ]
    The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6' days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.

  14. Tralokinumab Serum Trough Concentration at Week 16 [ Time Frame: At Week 16 ]
    Serum samples for determination of tralokinumab concentrations were analysed by a laboratory using a validated bioanalytical method.

  15. Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16 [ Time Frame: At Week 52 ]
    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).

  16. Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 52 Among Subjects With at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16 [ Time Frame: At Week 52 ]
    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.

  17. Tralokinumab Serum Trough Concentration at Week 66 [ Time Frame: At Week 66 ]
    Serum samples for determination of tralokinumab concentrations were analysed by a laboratory using a validated bioanalytical method.



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:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 12 to 17.
  • Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
  • History of AD for ≥1 year.
  • History of topical corticosteroid (TCS; Europe: Class 3 or higher; US: Class 4 or lower) and/or topical calcineurin inhibitor (TCI) treatment failure or subjects for whom these topical AD treatments are medically inadvisable.
  • 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:

  • 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, 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.
  • 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.

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): NCT03526861


Locations
Show Show 87 study locations
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] February 6, 2020
Statistical Analysis Plan  [PDF] April 23, 2021

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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03526861    
Other Study ID Numbers: LP0162-1334
2017-005143-33 ( EudraCT Number )
First Posted: May 16, 2018    Key Record Dates
Results First Posted: October 29, 2021
Last Update Posted: October 29, 2021
Last Verified: September 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