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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02525094
Registration number
NCT02525094
Ethics application status
Date submitted
29/07/2015
Date registered
17/08/2015
Date last updated
15/02/2018
Titles & IDs
Public title
Phase 2a Study to Evaluate the Efficacy and Safety of MEDI9929 in Adults With Atopic Dermatitis
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Scientific title
A Phase 2a, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI9929 in Adult Subjects With Moderate-to-Severe Atopic Dermatitis
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Secondary ID [1]
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D5240C00001
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Universal Trial Number (UTN)
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Trial acronym
ALLEVIAD
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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: Other - MEDI9929
Treatment: Other - Placebo
Experimental: MEDI9929 280 mg - Participants will receive 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10.
Placebo comparator: Placebo - Participants will receive 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10.
Treatment: Other: MEDI9929
Participants will receive 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10.
Treatment: Other: Placebo
Participants will receive 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10.
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Intervention code [1]
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Treatment: Other
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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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Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI 50) at Week 12
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Assessment method [1]
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The eczema area and severity index (EASI) evaluates 4 natural anatomical regions for severity (0 \[none\] to 3 \[severe\]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease. The EASI50 responder defined as a participant who achieved at least 50% reduction in EASI score from baseline.
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Timepoint [1]
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Baseline (Day 1) and Week 12
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Secondary outcome [1]
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Percentage of Participants Achieving >= 75 % Reduction From Baseline in EASI75 at Week 12
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Assessment method [1]
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The EASI evaluates 4 natural anatomical regions for severity (0 \[none\] to 3 \[severe\]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease. The EASI75 responder defined as a participant who achieves at least a 75% reduction in EASI score from baseline.
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Timepoint [1]
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Baseline (Day 1) and Week 12
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Secondary outcome [2]
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Mean Change From Baseline in EASI Total Score at Week 12
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Assessment method [2]
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The EASI evaluates 4 natural anatomical regions for severity (0 \[none\] to 3 \[severe\]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease.
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Timepoint [2]
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Baseline (Day 1) and Week 12
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Secondary outcome [3]
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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
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Assessment method [3]
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The investigator's global assessment (IGA) allows investigators to assess overall disease severity at one given time point and consists of a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, and 4 = 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 [3]
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Baseline (Day 1) and Week 12
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Secondary outcome [4]
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Mean Change From Baseline in the Scoring of Atopic Dermatitis (SCORAD) at Week 12
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Assessment method [4]
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The scoring of atopic dermatitis (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 range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease.
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Timepoint [4]
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Baseline (Day 1) and Week 12
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Secondary outcome [5]
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Percentage of Participants Achieving >= 50% Reduction From Baseline in SCORAD 50
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Assessment method [5]
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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 range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease. The SCORAD 50 responder defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline.
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Timepoint [5]
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Baseline (Day 1) and Week 12
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Secondary outcome [6]
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Percentage of Participants Achieving >= 75% Reduction From Baseline in SCORAD 75
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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 range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease. The SCORAD 75 responder is defined as a participant who achieves at least a 75% reduction in SCORAD score from baseline.
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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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Mean Change From Baseline in Average Pruritus Numeric Rating Scale (NRS) at Week 12
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Assessment method [7]
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Pruritus is assessed using an Numeric Rating Scale (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.
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Timepoint [7]
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Baseline (Day 1) and Week 12
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Secondary outcome [8]
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Mean Change From Baseline in 5-D Pruritus Score at Week 12
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Assessment method [8]
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The 5-D pruritus scale is a brief questionnaire designed to assess itch. This scale takes into account the multidimensional nature of pruritus, its impact on quality of life, and is capable of detecting change over time. The 5-D pruritus scale included 5 domains (duration, degree, direction, disability, and distribution of pruritus). The total 5-D score was obtained by scoring each of the domains separately and then summing them together. 5-D total scores ranged between 5 (no pruritus) and 25 (most severe pruritus). The higher values indicating more severe pruritus.
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Timepoint [8]
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Baseline (Day 1) and Week 12
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Secondary outcome [9]
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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 [9]
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An Adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of investigational product, whether or not considered related to investigational product. Serious adverse event is any AE that resulted in:death;inpatient hospitalization or prolongation of existing hospitalization;persistent or significant disability or incapacity;is life-threatening;is a congenital anomaly/birth defect in offspring of a study participant;or was an important medical event that may not have resulted in death, threatened life,or required hospitalization and that, based on appropriate medical judgment, may have jeopardized participant and may have required medical or surgical intervention to prevent one of outcomes above. TEAEs are defined as AEs 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 [9]
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From treatment administration (Day1) to 22 weeks
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Secondary outcome [10]
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Mean Trough Serum Concentration of MEDI9929
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Assessment method [10]
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The mean serum concentrations of MEDI9929 was observed at specified timepoints.
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Timepoint [10]
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Week 0 (Pre dose), Weeks 4, 8, and 12 (post dose)
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Secondary outcome [11]
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Number of Participants Who Developed Detectable MEDI9929 Anti-drug Antibodies
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Assessment method [11]
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A participant was considered ADA-positive across the study if they had a positive reading (titer of 50 or higher) at any time point during the study period.
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Timepoint [11]
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Baseline (Day 1) to Week 22
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Eligibility
Key inclusion criteria
* AD meeting Hanifin and Rajka criteria
* Age 18-75 years inclusive at screening
* Atopic dermatitis that affects greater than/equal to 10% body surface area
* Moderate to severe AD
* Effective birth control in line with protocol details
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Minimum age
18
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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
* Active dermatologic conditions which may confuse the diagnosis of Atopic Dermatitis
* Hepatitis B, C or HIV
* Pregnant or breastfeeding
* History of anaphylaxis following any biologic therapy
* History of clinically significant infections within 4 weeks prior to Visit 3
* Diagnosis of helminth parasitic infection within 6 months to screening
* History of Cancer except basal cell
* Receipt of any marketed or investigational biologic agent within 4 months to visit 3
* Any clinically relevant abnormal finding
* Major surgery within 8 weeks prior to Visit 1
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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
15/08/2015
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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
15/07/2016
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Sample size
Target
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Accrual to date
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Final
113
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - ACT
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Recruitment hospital [2]
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Research Site - Liverpool
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Recruitment hospital [3]
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Research Site - Woolloongabba
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Recruitment postcode(s) [1]
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02606 - ACT
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Recruitment postcode(s) [2]
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2170 - Liverpool
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Recruitment postcode(s) [3]
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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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Florida
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United States of America
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State/province [2]
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Illinois
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Country [3]
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United States of America
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Indiana
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United States of America
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State/province [4]
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New Jersey
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Country [5]
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United States of America
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State/province [5]
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North Carolina
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Country [6]
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United States of America
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State/province [6]
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Oregon
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Country [7]
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Canada
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State/province [7]
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British Columbia
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Country [8]
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Canada
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State/province [8]
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Ontario
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Country [9]
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Canada
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Quebec
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Country [10]
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Germany
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State/province [10]
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Berlin
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Country [11]
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Germany
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State/province [11]
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Frankfurt/Main
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Germany
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Gera
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Germany
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Hannover
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Germany
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State/province [14]
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Leipzig
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Germany
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State/province [15]
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München
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Germany
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State/province [16]
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Münster
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Hungary
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State/province [17]
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Debrecen
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Hungary
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Kaposvár
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Hungary
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Miskolc
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Hungary
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Pécs
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Hungary
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Szeged
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Hungary
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Szombathely
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New Zealand
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State/province [23]
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Tauranga
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New Zealand
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State/province [24]
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Wellington
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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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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Amgen
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
To assess the efficacy and safety of MEDI9929 in adult subjects with Atopic Dermatitis
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Trial website
https://clinicaltrials.gov/study/NCT02525094
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Eric Simpson, MD
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Address
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Oregon Health and Science University
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Phone
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Fax
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Email
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Contact person for public queries
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02525094
Download to PDF