Trial from ClinicalTrials.gov

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Trial ID
NCT02347176
Ethics application status
Date submitted
5/01/2015
Date registered
5/01/2015
Date last updated
11/05/2017

Titles & IDs
Public title
Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis
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
Secondary ID [1] 0 0
D2213C00001
Universal Trial Number (UTN)
Trial acronym
D2213C00001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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 will be administered subcutaneously to participants.

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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12 - 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.
Timepoint [1] 0 0
Week 12
Primary outcome [2] 0 0
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 - 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.
Timepoint [2] 0 0
Week 12
Secondary outcome [1] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) - 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.
Timepoint [1] 0 0
From Study Drug Administration to Week 22
Secondary outcome [2] 0 0
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events - 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.
Timepoint [2] 0 0
From Study Drug Administration to Week 22
Secondary outcome [3] 0 0
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events - 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 first dose of study drug and 10 weeks after the last dose 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.
Timepoint [3] 0 0
From Study Drug Administration to Week 22
Secondary outcome [4] 0 0
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events - 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.
Timepoint [4] 0 0
From Study Drug Administration to Week 22
Secondary outcome [5] 0 0
Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12 - EASI50 responder is defined as a participant who achieves at least a 50% reduction in EASI score from baseline.
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12 - The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of 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.
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12 - SCORAD 50 responder is defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline.
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12 - 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.
Timepoint [8] 0 0
Week 12

Eligibility
Key inclusion criteria
- Physician diagnosis of atopic dermatitis for > 1 year

- Atopic dermatitis involvement of = 10% body surface area

- EASI score of = 12

- SCORAD of = 25

- IGA score of = 3

- Effective birth control in line with protocol details
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of anaphylaxis following any biologic therapy

- Hepatitis B, C or HIV

- Pregnant or breastfeeding

- History of cancer

- Previous receipt of tralokinumab

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - East Melbourne
Recruitment hospital [2] 0 0
Research Site - Kogarah
Recruitment hospital [3] 0 0
Research Site - Liverpool
Recruitment hospital [4] 0 0
Research Site - Sydney
Recruitment hospital [5] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
- East Melbourne
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
- Liverpool
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment postcode(s) [5] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
Arkansas
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United States of America
State/province [3] 0 0
California
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United States of America
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Florida
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United States of America
State/province [5] 0 0
Massachusetts
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United States of America
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Michigan
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United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
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South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Bochum
Country [17] 0 0
Germany
State/province [17] 0 0
Dresden
Country [18] 0 0
Germany
State/province [18] 0 0
Dülmen
Country [19] 0 0
Germany
State/province [19] 0 0
Frankfurt/Main
Country [20] 0 0
Germany
State/province [20] 0 0
Hannover
Country [21] 0 0
Germany
State/province [21] 0 0
Munchen
Country [22] 0 0
Germany
State/province [22] 0 0
Münster
Country [23] 0 0
Germany
State/province [23] 0 0
Stuttgart-Weilimdorf
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Germany
State/province [24] 0 0
Wuppertal
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Japan
State/province [25] 0 0
Nakano-ku
Country [26] 0 0
Japan
State/province [26] 0 0
Shibuya-ku
Country [27] 0 0
Japan
State/province [27] 0 0
Shinjuku-ku
Country [28] 0 0
Japan
State/province [28] 0 0
Yokohama-shi
Country [29] 0 0
Poland
State/province [29] 0 0
Katowice
Country [30] 0 0
Poland
State/province [30] 0 0
Szczecin
Country [31] 0 0
Poland
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Warszawa
Country [32] 0 0
Poland
State/province [32] 0 0
Wroclaw
Country [33] 0 0
Poland
State/province [33] 0 0
Lódz

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
MedImmune LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with
atopic dermatitis
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries
Contact person responsible for updating information