Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis
NCT ID: NCT04212169
Last Updated: 2023-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
148 participants
INTERVENTIONAL
2019-12-09
2022-09-20
Brief Summary
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Detailed Description
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Each participant will be assigned randomly to a treatment arm, which could be different strengths of the active treatment or a placebo which does not contain active treatment. Both Participants and investigators will be masked to the treatment assignment.
Approximately 152 participants will take part in this study. There is a 4 weeks screening period to determine eligibility. After eligibility is confirmed, participants will receive investigational drug or placebo during the 16 weeks treatment period. This is then followed by an 8-week follow-up period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MEDI3506 at dose level 1
Participant will receive multiple doses of MEDI3506 at dose level 1.
MEDI3506
multiple doses
MEDI3506 at dose level 2
Participant will receive multiple doses of MEDI3506 at dose level 2.
MEDI3506
multiple doses
MEDI3506 at dose level 3
Participant will receive multiple doses of MEDI3506 at dose level 3.
MEDI3506
multiple doses
Placebo
Participant will receive multiple doses of Placebo
Placebo
multiple doses
Interventions
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MEDI3506
multiple doses
Placebo
multiple doses
Eligibility Criteria
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Inclusion Criteria
* Body mass index between 19.0 and 40.0 kg/m2 inclusive.
* Documented history of chronic AD, for at least 1 year prior to screening Visit 1.
* Meets at minimum 1 of the criteria, as follows:
* History of inadequate response to topical medications for AD
* Subject intolerance to treatment with topical medications for AD, or
* Topical medications are otherwise medically inadvisable
* AD that affects ≥ 10% of the body surface area (BSA).
* An EASI score of ≥ 12 at Visit 1 and ≥ 16 at Visit 3 (Day 1).
* An IGA score of ≥ 3.
Exclusion Criteria
* Any other clinically relevant abnormal findings from physical examination (including vital signs and electrocardiogram \[ECG\]) or from safety laboratory analysis.
* Active dermatologic conditions that might confound the diagnosis of AD or would interfere with the assessment of the skin.
* Known active allergic or irritant contact dermatitis.
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Santa Monica, California, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Tulsa, Oklahoma, United States
Research Site
Providence, Rhode Island, United States
Research Site
Spartanburg, South Carolina, United States
Research Site
Memphis, Tennessee, United States
Research Site
San Antonio, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Box Hill, , Australia
Research Site
Carlton, , Australia
Research Site
East Melbourne, , Australia
Research Site
Fremantle, , Australia
Research Site
Berlin, , Germany
Research Site
Dresden, , Germany
Research Site
Hamburg, , Germany
Research Site
Mahlow, , Germany
Research Site
Bialystok, , Poland
Research Site
Kielce, , Poland
Research Site
Lodz, , Poland
Research Site
Poznan, , Poland
Research Site
Skierniewice, , Poland
Research Site
Wroclaw, , Poland
Research Site
Alcobendas, , Spain
Research Site
Leganés, , Spain
Research Site
Seville, , Spain
Research Site
Corby, , United Kingdom
Research Site
High Wycombe, , United Kingdom
Research Site
Kenilworth, , United Kingdom
Research Site
Northwood, , United Kingdom
Research Site
Romford, , United Kingdom
Research Site
Shipley, , United Kingdom
Research Site
Sidcup, , United Kingdom
Research Site
Wokingham, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2019-003304-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D9182C00001
Identifier Type: -
Identifier Source: org_study_id
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