Phase 2a Study to Evaluate the Efficacy and Safety of MEDI9929 in Adults With Atopic Dermatitis
NCT ID: NCT02525094
Last Updated: 2018-02-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
113 participants
INTERVENTIONAL
2015-08-15
2016-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
MEDI9929
Participants will receive 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10.
Placebo
Participants will receive 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10.
Placebo
Participants will receive 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10.
Interventions
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MEDI9929
Participants will receive 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10.
Placebo
Participants will receive 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10.
Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Simpson, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Roderick Mcphee, MD
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Research Site
North Miami Beach, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Arlington Hts, Illinois, United States
Research Site
Carmel, Indiana, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Berlin, New Jersey, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Portland, Oregon, United States
Research Site
ACT, , Australia
Research Site
Liverpool, , Australia
Research Site
Woolloongabba, , Australia
Research Site
Surrey, British Columbia, Canada
Research Site
Barrie, Ontario, Canada
Research Site
Québec, Quebec, Canada
Research Site
Berlin, , Germany
Research Site
Frankfurt am Main, , Germany
Research Site
Gera, , Germany
Research Site
Hanover, , Germany
Research Site
Leipzig, , Germany
Research Site
München, , Germany
Research Site
Münster, , Germany
Research Site
Debrecen, , Hungary
Research Site
Kaposvár, , Hungary
Research Site
Miskolc, , Hungary
Research Site
Pécs, , Hungary
Research Site
Szeged, , Hungary
Research Site
Szombathely, , Hungary
Research Site
Tauranga, , New Zealand
Research Site
Wellington, , New Zealand
Countries
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Other Identifiers
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D5240C00001
Identifier Type: -
Identifier Source: org_study_id
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