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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/NCT02347176
Registration number
NCT02347176
Ethics application status
Date submitted
5/01/2015
Date registered
27/01/2015
Date last updated
23/05/2018
Titles & IDs
Public title
Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis
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Scientific title
A Phase 2b, Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Tralokinumab in Adult Subjects With Moderate-to-Severe Atopic Dermatitis
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Secondary ID [1]
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D2213C00001
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Universal Trial Number (UTN)
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Trial acronym
D2213C00001
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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
Other interventions - Placebo
Other interventions - Tralokinumab Dose 1
Other interventions - Tralokinumab Dose 2
Other interventions - Tralokinumab Dose 3
Placebo Comparator: Placebo - Placebo matched to Tralokinumab will be administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Experimental: Tralokinumab Dose 1 - Tralokinumab Dose 1 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
Experimental: Tralokinumab Dose 2 - Tralokinumab Dose 2 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
Experimental: Tralokinumab Dose 3 - Tralokinumab Dose 3 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
Other interventions: Placebo
Subcutaneous injection with placebo
Other interventions: Tralokinumab Dose 1
Subcutaneous injection with tralokinumab
Other interventions: Tralokinumab Dose 2
Subcutaneous injection with tralokinumab
Other interventions: Tralokinumab Dose 3
Subcutaneous injection with tralokinumab
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Intervention code [1]
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Other interventions
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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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Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12
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Assessment method [1]
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EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
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Timepoint [1]
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Baseline (Day 1) and Week 12
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Primary outcome [2]
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Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12
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Assessment method [2]
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The IGA allows investigators to assess overall disease severity at one given time point and consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline.
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Timepoint [2]
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Week 12
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Secondary outcome [1]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
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Assessment method [1]
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An adverse event (AE) present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug until Week 22. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received Tralokinumab. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.
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Timepoint [1]
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From Study Drug Administration (Day 1) to Week 22
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Secondary outcome [2]
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Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events
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Assessment method [2]
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Vital sign parameters included blood pressure, temperature, pulse rate, and respiratory rate. TEAEs were present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug until Week 22.
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Timepoint [2]
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From Study Drug Administration (Day 1) to Week 22
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Secondary outcome [3]
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Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
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Assessment method [3]
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An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
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Timepoint [3]
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From Study Drug Administration (Day 1) to Week 22
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Secondary outcome [4]
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Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events
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Assessment method [4]
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AEs observed in participants with clinically significant ECG abnormalities were assessed. ECG parameters included heart rate, RR, PR, QRS and QT intervals. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.
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Timepoint [4]
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From Study Drug Administration (Day 1) to Week 22
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Secondary outcome [5]
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Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12
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Assessment method [5]
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EASI50 responder is defined as a participant who achieves at least a 50% reduction in EASI score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a last observation carried forward (LOCF) analysis was used.
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12
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Assessment method [6]
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The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The maximum total score is 103, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
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Timepoint [6]
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Baseline (Day 1) and Week 12
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Secondary outcome [7]
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Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12
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Assessment method [7]
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SCORAD 50 responder is defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a LOCF analysis was used.
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Timepoint [7]
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Week 12
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Secondary outcome [8]
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Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12
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Assessment method [8]
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Pruritus assessed using an NRS (0 - 10) with 0= no itch and 10= worst imaginable itch. Daily pruritus assessments were summarized as weekly peak score and a change from baseline in weekly peak score was calculated. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
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Timepoint [8]
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Baseline (Day 1) and Week 12
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Eligibility
Key inclusion criteria
- Physician diagnosis of atopic dermatitis for greater than (>) 1 year
- Atopic dermatitis involvement of greater than or equal to (>=) 10 percent (%) body
surface area
- EASI score of >= 12
- SCORAD of >= 25
- IGA score of >= 3
- Effective birth control in line with protocol details
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Minimum age
18
Years
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Maximum age
75
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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
- History of anaphylaxis following any biologic therapy
- Hepatitis B, C or human immunodeficiency virus
- Pregnant or breastfeeding
- History of cancer
- Previous receipt of tralokinumab
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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 administering the treatment/s
The people assessing the outcomes
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 2
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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
23/01/2015
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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
5/02/2016
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Sample size
Target
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Accrual to date
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Final
204
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - East Melbourne
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Recruitment hospital [2]
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Research Site - Kogarah
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Recruitment hospital [3]
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Research Site - Liverpool
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Recruitment hospital [4]
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Research Site - Sydney
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Recruitment hospital [5]
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Research Site - Woolloongabba
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Recruitment postcode(s) [1]
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3002 - East Melbourne
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Recruitment postcode(s) [2]
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02217 - Kogarah
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Recruitment postcode(s) [3]
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2170 - Liverpool
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Recruitment postcode(s) [4]
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02010 - Sydney
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Recruitment postcode(s) [5]
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04102 - Woolloongabba
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Florida
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United States of America
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Massachusetts
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United States of America
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Michigan
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New Jersey
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New York
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Oregon
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South Carolina
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Texas
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United States of America
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Virginia
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Country [13]
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Canada
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British Columbia
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Canada
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Ontario
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Dülmen
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Germany
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Frankfurt/Main
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Germany
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Hannover
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Germany
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Munchen
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Germany
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Münster
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Germany
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Stuttgart-Weilimdorf
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Germany
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Wuppertal
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Nakano-ku
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Shinjuku-ku
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Japan
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Yokohama-shi
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Poland
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Katowice
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Szczecin
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Warszawa
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Wroclaw
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State/province [33]
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Lódz
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
MedImmune LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with
atopic dermatitis
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02347176
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02347176
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