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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03526861
Registration number
NCT03526861
Ethics application status
Date submitted
4/05/2018
Date registered
16/05/2018
Date last updated
6/05/2023
Titles & IDs
Public title
Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).
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Scientific 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
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Secondary ID [1]
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2017-005143-33
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Secondary ID [2]
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LP0162-1334
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tralokinumab
Treatment: Drugs - Placebos
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.
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.
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.
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.
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.
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
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
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
Treatment: Drugs: 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.
Treatment: Drugs: Placebos
Placebo contains the same excipients in the same concentration only lacking tralokinumab.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
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Assessment method [1]
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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).
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Timepoint [1]
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At Week 16
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Primary outcome [2]
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Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16
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Assessment method [2]
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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.
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Timepoint [2]
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At Week 16
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Secondary outcome [1]
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Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16
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Assessment method [1]
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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'.
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Timepoint [1]
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At Week 16
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Secondary outcome [2]
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Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16
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Assessment method [2]
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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.
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Timepoint [2]
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From Week 0 to Week 16
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Secondary outcome [3]
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Change in Children's Dermatology Life Quality Index (CDLQI) Score From Baseline to Week 16
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Assessment method [3]
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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.
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Timepoint [3]
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From Week 0 to Week 16
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Secondary outcome [4]
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Number of Adverse Events
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Assessment method [4]
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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.
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Timepoint [4]
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From Week 0 to Week 16
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Secondary outcome [5]
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Presence of Anti-drug Antibodies
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Assessment method [5]
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Anti-tralokinumab antibody levels were analysed using a validated bioanalytical method.
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Timepoint [5]
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From Week 0 to Week 16
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Secondary outcome [6]
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Subjects With at Least 50% Reduction in Eczema Area and Severity Index (EASI50) at Week 16.
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Assessment method [6]
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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.
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Timepoint [6]
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At Week 16
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Secondary outcome [7]
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Subjects With at Least 90% Reduction in Eczema Area and Severity Index (EASI90) at Week 16.
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Assessment method [7]
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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.
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Timepoint [7]
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At Week 16
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Secondary outcome [8]
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Change in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16
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Assessment method [8]
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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.
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Timepoint [8]
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From Week 0 to Week 16
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Secondary outcome [9]
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Subjects With at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD75) at Week 16
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Assessment method [9]
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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.
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Timepoint [9]
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At Week 16
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Secondary outcome [10]
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Subjects With at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD50) at Week 16
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Assessment method [10]
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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.
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Timepoint [10]
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At Week 16
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Secondary outcome [11]
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Change in Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) From Baseline to Week 16
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Assessment method [11]
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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'.
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Timepoint [11]
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From Week 0 to Week 16
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Secondary outcome [12]
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Participants With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 3 From Baseline to Week 16
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Assessment method [12]
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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'.
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Timepoint [12]
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At Week 16
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Secondary outcome [13]
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Change in Patient Oriented Eczema Measure (POEM) From Baseline to Week 16
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Assessment method [13]
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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.
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Timepoint [13]
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From Week 0 to Week 16
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Secondary outcome [14]
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Tralokinumab Serum Trough Concentration at Week 16
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Assessment method [14]
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Serum samples for determination of tralokinumab concentrations were analysed by a laboratory using a validated bioanalytical method.
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Timepoint [14]
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At Week 16
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Secondary outcome [15]
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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
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Assessment method [15]
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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).
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Timepoint [15]
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At Week 52
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Secondary outcome [16]
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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
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Assessment method [16]
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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.
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Timepoint [16]
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At Week 52
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Secondary outcome [17]
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Tralokinumab Serum Trough Concentration at Week 66
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Assessment method [17]
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Serum samples for determination of tralokinumab concentrations were analysed by a laboratory using a validated bioanalytical method.
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Timepoint [17]
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At Week 66
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Eligibility
Key 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.
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Minimum age
12
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/06/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/03/2021
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Sample size
Target
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Accrual to date
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Final
301
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Leo Pharma Investigationel Site - Darlinghurst
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Recruitment hospital [2]
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Leo Pharma Investigationel Site - Kogarah
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Recruitment hospital [3]
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Leo Pharma Investigationel Site - Melbourne
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Recruitment hospital [4]
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Leo Pharma Investigationel Site - Woolloongabba
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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3002 - Melbourne
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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Fukuoka
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Kyoto
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Osaka
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Tsu
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Kraków
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Swidnik
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Wroclaw
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Lódz
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United Kingdom
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Glasgow
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
LEO Pharma
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Address
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Ethics approval
Ethics application status
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Summary
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.
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https://clinicaltrials.gov/ct2/show/NCT03526861
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LEO Pharma
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03526861
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